According to Food and Drug Administration (FDA), a ‘generic drug’ is the same as a brand name drug in many aspects such as dosage, safety, strength, how it is taken, quality, performance, and intended use. On the other hand, the term supergeneric is applied to the development process for small molecule drugs which represent new therapeutic entities which demonstrate an improvement in either product delivery, design or through the application of a more efficient manufacturing process.

The comparison between generics, super generics, and new chemical entities is shown in the figure below. If such a product is launched by the originator it is considered as a ‘life cycle management’ or ‘brand extension’. If it is launched by a generic company, then such a product is called ‘super generics’.

There are many super generic types depending on their application and innovation, such as:

1. Combination products of patent expired drugs.

2. Products demonstrating therapeutic differentiation from mono-therapies.

3. New dosage forms of off-patent drug substances.

4. Altering pharmacokinetic profiles.

5. Enhanced bioavailability and dose reduction.

Super Generics as promising market

The super generics global market is estimated to reach the anticipated market value of USD 413 billion by 2033 while expanding its global space at a promising CAGR of 7.2% (2023 to 2033). The market holds a revenue of USD 205 billion in 2023.

In Europe, the market was valued at USD 11.4 billion in 2022 and is expected to reach USD 14.2 billion by 2033. It is estimated to surge at a CAGR of close to 2.0% over the forecast period from 2023 to 2033. The anti-diabetic segment held 13.3% in terms of value share and topped Europe in the drug class category in 2022.

The market’s growth prospects as an outcome of the growing demand for alternative medicine and medically advanced companies increasing their research and development programs to add more value to the generics. ultimately helps the end user, the patient, apart from the quality drugs manufactured for a specific disease. The super generic helps the patient in reviving soon and smoothly.

Moreover, the growing geriatric population and dependence on alternate and generic medicines are increasing daily while governments worldwide are working hard to make generic medication available for end users.

Many super generic products stand in the global market and here are some examples:

1) Abraxane

a super generic form of Taxol (FDA, 2005), which uses albumin to deliver the chemotherapy, not Cremophor, and so avoids hypersensitivity and claims a greater tumor response rate than Taxol. The drug Abraxane (nanoparticle albumin-bound paclitaxel) uses the approach of coating Taxol with albumin to reduce the side effects associated with standard Taxol (paclitaxel), making it possible to give it without steroids.

2) Subacap

a super generic of the conventional itraconazole formulation used to treat fungal infections. Mayne Pharma Subacap provides enhancements to patients and prescribers with reduced inter- and intra-patient variability and therefore a more predictable clinical response enabling a reduction in active drug quantity to deliver therapeutic blood levels. Itraconazole is one of the broadest spectrum antifungal drugs on the market and can be used to treat both superficial fungal infections such as onychomycosis (nail infection) and systemic fungal infections such as histoplasmosis, aspergillosis and candidiasis which can be life-threatening to immunocompromised patients.

3) Absorica

Ranbaxy Laboratories Limited launched Absorica Capsules in U. S healthcare market, a superior version of (Isotretinoin). Absorica is being prescribed for the treatment of severe recalcitrant nodular acne in patients of the age group of 12 years and above. The drug has a total market size of $1 billion (at the price of Absorica). Absorica, a super generic version of isotretinoin that is bioequivalent to the Accutane capsule when both are taken with a high-fat meal. But the former shows a better bioavailability than the latter when taken fasted. 

4) Dymista

Cipla & Meda, the two generic players, signed the MOU and came into collaboration to get commercialization rights for Dymista, used for seasonal allergic rhinitis. Dymista (Azelastine hydrochloride and fluticasone propionate) is a novel formulation of Azelastine Hydrochloride, an antihistamine, and Fluticasone Propionate; a corticosteroid approved by the US FDA in May 2012.

Dymista is being marketed as a sprayed suspension designed for intranasal administration. The recommended dose of Dymista is one spray per nostril twice daily. Dymista has consistently shown speeder and more complete symptom relief than standard treatment in the US and was approved in the US in May 2012 and in Europe in January 2013.

5) Ambil and Doxisome

Ambil is the liposomal encapsulate formulation of Amphotericin B & Doxisome is the liposomal formulation of Doxorubicin. Both formulations come under the super generic category and can register marked improvement in patients’ compliance by reducing side effects and providing an effective dosage.

The Role of Patents in Pharmaceutical Innovation

Patents serve as a cornerstone of pharmaceutical innovation by offering legal protection that encourages investment in research and development (R&D). This is particularly critical in the pharmaceutical sector, where the development of a new drug—or an enhanced version, such as a super generic—requires substantial financial and time commitments. By granting innovators exclusive rights for a limited period (typically 20 years from filing), patents ensure a temporary monopoly, allowing companies to recoup their investments and reinvest in future advancements.

Pharmaceutical innovation thrives on addressing unmet medical needs or improving existing therapies. Super generics exemplify this innovation, offering improved bioavailability, novel delivery mechanisms, or better therapeutic outcomes compared to their traditional generic counterparts. For instance, drugs like Abraxane and Absorica demonstrate how patents incentivize the development of enhancements that provide significant clinical and commercial benefits.

Moreover, the costs of clinical trials and bioequivalence studies for super generics, although lower than for new chemical entities, remain substantial. Patents help justify these expenses by safeguarding the resulting innovations from immediate replication by competitors. This assurance is especially critical for companies developing unique formulations, such as controlled-release systems or liposomal encapsulations, which require significant technical expertise.

Finally, patents contribute to broader pharmaceutical progress by fostering collaborations and licensing agreements. Innovators can leverage their patent portfolios to attract partners or licensees, as seen in the case of Dymista, where Cipla and Meda used the patented dual-action formulation to mutual benefit. In this way, patents not only protect individual inventions but also promote knowledge-sharing and investment across the industry.

Challenges Faced by Super Generic Manufacturers

Super generic manufacturers face unique challenges in bringing their products to market. Unlike traditional generics, which largely avoid the complexities of innovation, super generics require careful planning including navigating existing patents, meeting stricter requirements, and evaluating the risk of legal challenges.

Navigating Existing Patents

One of the biggest hurdles is understanding and working around the patents that protect active pharmaceutical ingredients (APIs) and formulations. Developers of super generics must conduct thorough Freedom to Operate (FTO) analyses to ensure their products don’t infringe any existing patents. This involves identifying gaps in the patent landscape where improvements can be made legally. However, this process is complex, time-consuming, and can lead to unintentional disputes if overlooked. Without careful patent research, manufacturers risk expensive litigation or delays in product approval.

Meeting Stricter Requirements

Super generics are held to much higher standards than standard generics. While traditional generics only need to prove bioequivalence to the originator drug, super generics must demonstrate the added value of their improvements. This often means conducting additional lab tests, stability studies, and even clinical trials to prove enhanced efficacy, safety, or delivery mechanisms. These extra requirements come with significant costs, which can strain smaller companies that lack the resources of larger pharmaceutical firms.

Risk of Legal Challenges

Despite efforts to innovate within legal boundaries, super generic manufacturers often face litigation from originator companies. These companies may argue that the innovations in super generics are too similar to their patented products, even if the patents on the original API have expired. Lawsuits can be financially and reputationally damaging, and defending against them requires substantial legal expertise. For smaller players in the industry, these challenges can be a major deterrent to innovation.

Strategic Use of Patents by Super Generic Manufacturers

Super generic manufacturers employ strategic patenting practices to attain a competitive edge in the pharmaceutical market. Unlike traditional generics, which replicate off-patent drugs without modifications, super generics rely on innovations that must be carefully protected to ensure market success. Many strategies can be conducted after patent granting, the main strategies are:

1) Securing Secondary Patents

While the primary patent on the active pharmaceutical ingredient (API) may have expired, super generic manufacturers often file secondary patents for:

• Formulations: Novel delivery mechanisms or dosage forms, such as the nanoparticle-based formulation of Abraxane.
• Processes: Improved or more cost-effective manufacturing methods, like those used for Subacap.
• Combination Therapies: Unique combinations of APIs, as in Dymista.

These secondary patents extend exclusivity and make it harder for competitors to introduce bioequivalent products.

2) Building Patent Thickets

A “patent thicket” involves filing multiple overlapping patents around a single product to create a robust barrier against generic competition. For example, a super generic manufacturer might patent various aspects of a drug, including its formulation, delivery method, and manufacturing process. This strategy complicates the pathway for competitors seeking to launch competing products.

3) Defensive Patenting

Super generic manufacturers also use defensive patenting to block rivals from entering the market. By filing patents on foreseeable modifications or improvements, they limit the ability of competitors to innovate in the same space.

4) Licensing and Revenue Generation

Patents are valuable assets that can generate revenue through licensing agreements. For instance, the partnership between Cipla and Meda on Dymista illustrates how super generic manufacturers can monetize their innovations by licensing patented technologies to larger pharmaceutical companies.

5) Supporting Lifecycle Management

For originator companies venturing into super generics, patents serve as a vital tool for lifecycle management. By patenting improved versions of their original products, they can sustain revenue streams even after the primary patent expires. This approach is particularly evident in products like Ambil and Doxisome, which use patented liposomal formulations to enhance patient outcomes.

6) Mitigating Market Risks

Patents also serve as a risk mitigation tool. They provide legal grounds for challenging infringing competitors and ensure that investments in product development are not undermined by immediate copycat products.

Summary and Conclusion

Super generic medicines are a step beyond traditional generics, offering improved formulations, better delivery methods, and enhanced therapeutic effects. They address unmet medical needs while remaining cost-effective, as seen in examples like Abraxane and Dymista. With the global market projected to double by 2033, super generics are gaining traction due to rising healthcare needs and government support for affordable medicine.

Patents are crucial for protecting these innovations and ensuring companies can recover their investments. Strategies like securing secondary patents and forming licensing partnerships help manufacturers stay competitive. However, navigating existing patents, meeting stricter regulations, and avoiding legal disputes pose significant challenges.

In conclusion, super generics combine innovation with accessibility, filling an important niche in the pharmaceutical landscape. With thoughtful patent strategies and ongoing innovation, they are poised to make a lasting impact on global healthcare.

References

1. Suresh Garud. “SUPERGENERICS – A COST SAVING PARADIGM.” International Journal of Pharmaceutical Research & Development 5 (January 2014).
2. “Super Generics Market Outlook (2023 to 2033).” Future Market Insights, July 2023. https://www.futuremarketinsights.com/reports/super-generics-market. Accessed on 20 November 2024.

3.“Europe Super Generics Industry Outlook from 2023 to 2033.” Future Market Insights, October 2023. https://www.futuremarketinsights.com/reports/super-generics-industry-analysis-in-europe. Accessed on 20 November 2024

4.LOKESH KUMAR. “SUPER GENERICS / IMPROVED THERAPEUTIC ENTITIES: AN APPROACH TO FULFIL UNMET MEDICAL NEEDS AND EXTENDING MARKET EXCLUSIVITY OF GENERIC MEDICINES” International Journal of Pharmaceutical Science 7 (November 2014)  
5. Barei, Fereshteh, Claude Le Pen, and Steven Simoens. “The Generic Pharmaceutical Industry: Moving beyond Incremental Innovation towards Re-Innovation.” Generics and Biosimilars Initiative Journal 2, no. 1 (March 15, 2013).

6. ABG Intellectual Property. “Freedom to Operate Reports (FTO). https://abg-ip.com/freedom-to-operate-reports/. Accessed on 25 November 2024.

7. Patents. “Frequently Asked Questions: Patents,” https://www.wipo.int/web/patents/faq_patents. Accessed on 25 November 2024.

Artykuł Patents Cruciality for Super Generic Medicines pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Due to the registration qualifications, there are innovative and generic drugs as well as preparations with the so-called well established use. Companies producing innovative (original) drugs are of great importance in the development of new technologies. However, the pharmaceutical industry in Central and Eastern Europe is dominated by companies producing generic drugs (the so-called generics).
Generic drugs are equivalents of original products, the patent protection of which has already expired or has not been applied for. The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same.
Analysts say that the generic drugs market in 2008 was worth EUR 17.2 billion, and predict its further development. Also in Poland, generic companies have a large share in the pharmaceutical sector. Among many European countries, it is Poland that is the leader in terms of value and quantity of generic drugs sold. In terms of value, generic drugs constitute 88% of the drug market in our country, and in quantitative terms – approx. 66%, which is definitely more than in other countries.

Patent law regulations in UE

Generic drugs and biosimilars are manufactured and placed on the market after the period of protection of innovative drugs – in particular, patent protection and protection resulting from granting a given product the so-called Supplementary Protection Certification (“SPC”).
Currently, the legal act regulating the SPC is Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 on the supplementary protection certificate for medicinal products (the “SPC Regulation”).
According to it, the term of patent protection in the European Union is 20 years and may be extended for another 5 years. As a rule, medicinal products are protected by multiple patents – in some cases from 20 to 40 patents and sometimes even more. According to the data of the European Commission, there is a drug protected in the European Union by up to 1,300 different patents. Patent protection may apply to the product itself, the manufacturing process, use or formulation.
A separate element of patent protection is Data Exclusivity of an innovative medicine. Data exclusivity determines the period during which the company applying for registration of a generic medicine cannot refer to the results of clinical trials conducted by the manufacturer of the original drug. In such a case, the generic medicine may be placed on the market only after the period of data exclusivity has expired. When applying for registration of a generic drug, the same rules apply as in the case of introducing original drugs to the market. Drug registration is valid for 5 years. During this time, the manufacturer is required to assess the safety of its own product and all other drugs containing the same active substance. The registration can be renewed with a comprehensive safety report.
Companies producing innovative drugs try to use many mechanisms that may delay the introduction of generic drugs to the market. The most frequently introduced strategies of pharmaceutical companies include refreshing patents, increasing the number of patents for the same drug, bringing court cases against manufacturers of generic drugs, and applying for a generic sales ban until a court dispute is resolved.

SPC Manufacturing Waiver

It is worth paying attention to the recent changes in patent law, namely to the restriction of patent law introduced by the European Union. It turned out that strong regulations limited European generics producers to such an extent that they lost their competitiveness.
Previously, a manufacturer with plants outside this area could start the production of drug equivalents during the protection period (without being accused of infringement of exclusive rights). As a result, it was able to bring generics to the European market as soon as the SPC has expired.
On the other hand, entrepreneurs whose production centers were located within the European Union were in a much worse situation. Under the previous legislation, they could start production only after the expiry of the additional protection right. As a result, generic drugs manufactured by manufacturers from Europe appeared on the market a few months later than the goods of entrepreneurs operating outside the European Union. These few months could be crucial for building a competitive advantage.
For this reason, the European Union has granted manufacturers of generic drugs a special privilege called SPC Manufacturing Waiver. A production exception introduced by Regulation (EU) 2019/933 of the European Parliament and of the Council of May 20, 2019 amending the SPC Regulation (“SPC Waiver Regulation”) allows generic drug manufacturers to:
o manufacture, within the territory of the European Union, of medicinal products for the purpose of export to the markets of third countries, as well as any related operations necessary for such manufacture or for the export itself.
o production and storage of medicinal products in a Member State within 6 months prior to the expiry date of the SPC in order to enter the Member State’s market from the first day after the expiry of the SPC, as well as any related operations strictly necessary for such manufacturing or storage, provided that such related activities will take place no earlier than six months before the expiry of the SPC.
These activities are intended to help manufacturers of generic and biosimilar medicinal products to compete effectively on the markets of third countries and to provide support for manufacturers of generics and biosimilars to compete effectively in the territory of the Union from the first day after the expiry of the SPC protection.

Launching a generic drug to the market

Thanks to the guarantee of equally high production standards and constant monitoring of safety and effectiveness, patients can freely choose the product that best suits them in the pharmacy. The manufacturing process of generic drugs must follow the principles of Good Manufacturing Practice (GMP). Compliance with the GMP rules allows for the provision of good quality medical devices.
A drug must also undergo the appropriate amount of tests and studies. The drug must contain the same composition (quantitative and qualitative) of active substances as the original (reference) medicinal product, must be at the same form (tablets, syrup, inhaler, etc.) as the original and it has to prove that its operation is consistent with the reference medicinal product (bioequivalence and bioavailability studies).
The highest quality standard in Europe is The Certificate of Suitability (CoS) awarded by the European Directorate for the Quality of Medicines (EDQM). It confirms that the active substances meet the requirements of the European Pharmacopoeia standards.
After approval of a generic drug, it is subject to further “observation”, similarly to innovative drugs. Regardless of the type of drug manufactured, all pharmaceutical companies are required to monitor the use and safety of a given product. Due to the fact that generic drugs are introduced to the market many years after the appearance of the original drug, the effects of the active substance contained in them are already well known. For this reason, the occurrence of unpredictable side effects is very rarely observed. However, this does not release the company from supervision over the safety of a specific medicinal product (pharmacovigilance). Such procedures are to confirm that effective and safe medicinal products are available on the market.
The marketing of a generic drug is simpler than the registration of an innovative drug, as the applicant may rely on the clinical and preclinical studies of the prototype. He is obliged to provide evidence that the quality, effectiveness and safety requirements have been met. The registration process of a generic drug itself takes from 1 to 2 years, sometimes it may be extended.

Polish law and the problem with the obligatory reduction of drug prices

In Poland, generic drugs are regulated in the Pharmaceutical Law Act of September 6, 2001. It guarantees the Polish patient the possibility of replacing the original drug with a cheaper equivalent – the pharmacist, at the patient’s request, may issue a drug other than the drug prescribed on the prescription, with the same international name, dose, pharmaceutical form or similar pharmaceutical form, which does not cause therapeutic differences, and about this the therapeutic indication itself, the price of which is lower than the price of the drug prescribed on the prescription. This process is called “generic substitution”.
In Poland, however, generics are one of the cheapest in Europe and, contrary to appearances, it is not a positive fact at all. According to the report of the Polish Association of Pharmaceutical Industry Employers, the average cost of one tablet of a generic drug sold in hospital and pharmacy channels is 10 cents. It is less than in another 19 EU countries, with which Poland was compared. It is still so cheap in the Netherlands and Romania. In other EU countries, one generic tablet is more expensive.
In Poland, according to the applicable reimbursement act, the first generic drug to enter the reimbursement list must be 25 percent cheaper than a drug that has expired. If more generics appear on the market, the price drops even more. Despite the fact that this is the case – the Ministry of Health, during the negotiations, forces producers to reduce the prices of the same products every three years – as a result, Poland has reached the lowest level in the EU.

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Further price reductions will inhibit the development of the domestic industry for which the Polish market is a priority, as assessed by the Polish Association of Pharmaceutical Industry Employers. A significant drop in the profitability of the production of pharmaceutical products in Poland results in a reduction in investment outlays. The large difference in prices between Poland and other EU countries is conducive to the illegal export of drugs abroad. It also threatens to give up sales on the Polish market, because lowering prices in one country generates similar price expectations in other markets. As a result, Polish patients may be left without therapy.

Sources:
https://journals.viamedica.pl/forum_medycyny_rodzinnej/article/viewFile/10143/8643
https://www.rp.pl/zdrowie/art9707421-spc-manufacturing-waiver-czyli-przywilej-wczesniejszej-produkcji-generycznej
https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:32009R0469&from=FR
https://medycynaipasje.com.pl/a2184/Co-warto-wiedziec-o-lekach-generycznych-.html
https://przemyslfarmaceutyczny.pl/artykul/spc-manufacturing-waiver-czyli-mozliwosc-produkcji-lekow-generycznych-i-biopodobnych-na-magazyn-lub-w-celu-ich-eksportu-w-okresi
https://www.prawo.pl/zdrowie/ceny-lekow-generycznych-w-polsce-i-krajach-unii,505885.html
https://pulsmedycyny.pl/leki-generyczne-w-polsce-sa-najtansze-w-ue-1107714

Artykuł THE LEGAL ASPECTS OF GENERIC DRUGS – EU AND POLAND pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.