Over the years, many top drugs have witnessed its growth and development due to its novelty. But as the patent is about to expire for this top pharma industry drugs, many generic competitors are ready to enter the pharma market and give a tough time to these leading drugs.
As generic drugs offer high affordability the revenue for them is expected to rise decreasing the sale of novel drugs.
Why Are Drug Patents Important?
Here are some key points about pharmaceutical drugs patent expiry:
- Drug patents serve as a protection shield to the novel drug, when the drug is patented, no other company can manufacture its generic version. 
- It helps in drug brand recognition.
- The patent helps the innovator to profit from its revenue.
- Patents promote research development and innovation.
- Patents help to cope with the cost of the development and research of the novel drug.
- Patent restricts the loss of exclusivity of the drugs.
- The balance of market access and their returns is maintained by patents.
List Of Expected Patent Expiry Drugs By 2030:
Below are the patent expiry drugs explained in depth that are losing their patents in the upcoming years.
| Drug Name | Company | 2023 Sale (Approx) | Patent Expiry |
| Imbruvica | AbbVie / Johnson & Johnson | $4B | 2027 |
| Apixaban | BMS / Pfizer | $12B | 2026 |
| Keytruda | Merck | $25B | 2028 |
| Revlimid | Bristol Myers Squibb | $9B | 2025 |
| Eliquis | BMS/Pfizer | $12B | 2026 |
| Ibrance | Pfizer | $5.39B | 2027 |
| Enbrel | Amgen | $3B | 2028 (EU) 2029 (US) |
| Opdivo | Bristol Myers Squibb | $9B | 2028 |
| Trulicity | Eli Lilly | $7B | 2027 |
| Xarelto | Bayer/ Janssen (J &J) | $4.5B | 2026 |
| Eylea | Regeneron / Bayer | $9B | 2025 |
| Januvia | Merck | $1.5B | 2025 |
| Prolia/Xgeva | Amgen | $5B | 2026 |
| Stelara | Johnson & Johnson | $10B | 2024 (EU) 2025 (US) |
| Dolutegravir | GSK / ViiV Healthcare | $2B+ | 2027 |
| Cosentyx | Novartis | $5B+ | 2027 |
| Ozembic | Novo Nordisk | $3.6B | 2025 |
| Xtandi | Astellas / Pfizer | $4B | 2027 |
Drugs losing patent protection in the next five years
Over the next five years, several high-profile drugs are expected to lose patent protection. Here are some notable examples:
Imbruvica (Ibrutinib):
- Imbruvica was found to be approved by the FDA in the year 2013
- Various blood cancers including chronic lymphocytic leukemia (CLL) are treated using the drug Imbruvica.
- There are certain generics that have come in, but some legal procedures remain for their final approvals.
- Imbruvica patent expiration is expected in the year 2027.
Apixaban:
- Apixaban is a drug used to treat blood clot formation that takes place in the blood vessels.
- Apixaban got approval from the FDA in 2012.
- The Apixaban patent expiry is expected by the year 2023.
Keytruda:
- Keytruda is a novel drug used to treat conditions like biliary tract cancers (which include cancers of the gall bladder, biliary duct, etc.), breast cancers, gastroesophageal cancers, etc.
- This drug is a highly demanding drug with its peak growth in the pharma market.
- Keytruda was approved by the FDA in 2014, and its patent is about to expire in 2028.
Revlimid:
- Bristol Myers Squibb invented a novel drug called Revlimid.
- Conditions such as multiple myeloma are known to be treated with Revlimid.
- This drug is known to be approved in 2005 by the FDA.
- Revlimid has recorded its peak sale of $9 billion in the year 2025.
- Its first generic from India’s Natco Pharma was approved in 2022 and is waiting for the drug patent expiration of Revlimid in 2025.
Eliquis:
- Eliquis is the novel creation of the company Pfizer and Bristol Myers Squibb.
- It has been proven to be a blockbuster drug for the treatment and prevention of blood clot formation.
- Eliquis saw a 16% increase in its sales in 2020 increasing to a sale of $12 Billion in 2025.
- The manufacturers of Eliquis have another formulation of an anti-coagulant drug with a patent expiry in the year 2031.
- For now, there are no generic approved for this drug, but there is a prediction for it’s generic to come in soon.
Ibrance:
- Ibrance is used to treat metastatic breast cancers.
- Ibrance is a novel creation by Pfizer with patent validity up till 2027.
- After the approval of Ibrance, there were certain companies that attempted to launch their generics trying to claim false statements against the approval of Pfizer’s patent for Ibrance. However, these generic companies failed in their false plans.
- In the early phase of Ibrance, it recorded a 7% decline in its sales rate but then after some years, it recorded a 9% sale growth every year with a sale of $5.39 Billion recorded in 2024.
Enbrel:
- Enbrel is an injectable drug used to treat conditions like rheumatoid arthritis, ulcerative colitis, etc.
- It has been found that there are 19 active patents that are active for various formulations of this drug protecting its novelty till 2029.
- Enbrel, through its sales, has managed to generate a revenue of $ 3.3 billion.
- While no generics are available yet, there have come into existence some biosimilars that are ready to compete with Enbrel in the pharma market.
Opdivo:
- Cancers such as colorectal cancer and esophageal cancer are treated using the novel drug Opdivo.
- This drug is carrying out its research to form combinational therapies.
- This drug has brought a revolution in cancer treatment.
- Opdivo is expected to expire its patent in the year 2028.
Trulicity:
- Trulicity is a blockbuster production of Eli Lilly company aiming to target type 2 diabetes patients.
- Trulicity witnessed a growth of 24% in 2024.
- There are many generic competitors ready to enter the pharma market soon after the drug patent expiration of Trulicity this decade.
- The drug won a highly anticipated FDA nod in 2020 for reducing the risk of cardiovascular effects in type 2 diabetes patients.
- Trulicity with its admirable results is expected to take over half of the pharma injectables market for type 2 diabetes.
Xarelto:
- Xarelto is also known for treating blood clot formation, that is it belongs to the anti-coagulant category.
- Xarelto is a key production of Bayer and Johnsons which was approved in the year 2007 and is expected to expire in 2026.
- In 2022 it was recorded as the best manufacturing drug in the US.
Eylea:
- Eylea is another blockbuster drug of Bayer which is expected to expire in 2026.
- A 5.9 billion sales were recorded for Eylea in the year 2023.
- Companies such as Sandoz and Viatris are ready with their biosimilars to enter the market soon after the patent expiration.
Januvia:
- Januvai is an innovation production of the company Merk targeting to treat type 2 diabetes.
- Januvia is a combination drug of sitagliptin and metformin.
- Januvia observed a drop in sales of 4% on its last sale with its expected patent expiration in 2023.
- Zituvio, a generic of Januvia is about to enter the pharma market soon after the patent expiry of Januvia.
Prolia/Xgeva:
- Prolia was invented by the company Amgen for the treatment of secondary bone cancer.
- Prolia observed a 9% increment in its sales in the year 2023.
- This drug is going to expire this year, with its competitive generics ready to enter the market.
- Two new biosimilars of denosumab have been approved by the FDA, which are generics of Prolia/ Xgeva.
Stelara:
- Stelara is blockbuster drug of Johnson and Johnson which is expected to lose its patent in 2026.
- This drug is recording a 21% increase in its sales since 2019.
- In 2024 it recorded a revenue collection of $10 billion.
- Biosimilars such as Stelarsdi have been approved by the FDA for its sale in the US.
Dolutegravir:
- GlaxoSmithKline is the company who manufactured Dolutegravir for the first time for the treatment of AIDS.
- The patent for this drug is going to expire in 2029.
- No such generics are found up till now who are ready to compete with Dolutegravir.
- This drug has managed to collect a revenue of $2 plus billion in 2024.
Cosentyx:
- In 2015 Novartis produced Cosentyx for the treatment of psoriasis, ankylosing spondylitis, etc.
- It observed a 14% incremental sale in 2020 and recorded a revenue of $5 plus billion in 2024.
- The patent for this drug is going to expire in 2026, with no biosimilars yet approved to enter the market.
- However, there are biosimilars on which research is going to compete with Cosentyx.
Ozembic:
- Ozembic is an injectable used to treat cardiovascular symptoms.
- It recorded a revenue of $3.6 billion in 2024, and its patent is about to expire this year.
- Companies such as Sun Pharma, Dr. Reddy are all set to enter with their generics soon after the patent expiry.
Xtandi:
- Xtandi is an anti-cancer drug developed in 2009 by Medivation which is a part of Pfizer company now.
- Xtandi’s patent is expected to expire in 2027.
- Zydus is expected to get the US FDA approval for the generic sale of Xtandi.
- A revenue of $4 billion was generated by Xtandi in 2024.
Strategies To Extend Patent Expiration:
The manufacturers of novel drug sometimes follow strategies to extend their patent expiration. Some of the strategies are as follows:
- Patent evergreening: The manufacturers make some slight changes to the drug formulation and file a new patent, thus increasing the patent life of the drug.
- Supplementary Protection Certificate (SPCs): This certificate is issued by the drug manufacturer to extend some more years of patent validity by adding the years lost during the drug approval process.
- Pediatric exclusivity: The patent validity can be increased up to 6 months when drug studies are carried out for pediatric drug products.
Conclusion:
Thus, we came to know that there are many blockbusters drugs that are soon going to expire this decade and many of the generics are approved by the FDA and are all set to soon launch in the pharma market after the novel drug patent expiration. Generics are widely accepted and offer affordability that makes it the most prescribed drug declining the sale of novel drug by which its revenue drops down. However, some of the novel drug manufacturers follow strategies to extend their patent and keep it safe from the generic competitors.
For any regulatory help for your drug to launch in the market or any patent-related procedures, our experienced team at Artixio is ready to help you make your regulatory journey easy and help you achieve success with your pharma product in the market. So, contact today at info@artixio.com.
FAQs:
From where can I know about the patent expiry dates?
The FDA has a book called orange book which has in it all the enlisted drugs and their patent approval period, thus from the orange book we can find out the expiry dates of drug patents.
What are authorized generics?
Authorized generics are the generic form of original branded drug sold under the generic name. These authorized generics come into the market soon after the patent expiry and compete with other generics.
What is Paragraph IV certification?
Paragraph IV certification is used by the generic manufacturers to challenge the validity of drug patents, after which if they are successful, they can launch early their own generic product in the market.
Is the patent expiry date the same globally?
No, patent expiry is region specific. The drug patent may expire in different year in US and in different year in India. Thus, to know the drug patent expiration date one should look in for its region specifically.
