Many blockbuster drugs that have held a strong position in the market are now moving closer to patent expiry. As their protection ends, generic and biosimilar manufacturers may get a chance to launch competing versions.
The expected patent expiry drugs list below covers important drugs coming off patent by 2030 and their drug patent expiration dates, along with products nearing loss of exclusivity.
Why Are Drug Patents Important?
Patent drugs, or patented drugs, have protection that keeps generic versions from entering the market for a period of time. For pharmaceutical companies, this gives some room to recover the money spent on research and development and continue working on new treatments. Drug patents also help in several other ways:
- prevent other manufacturers from making and selling generic versions while patent protection is active
- help protect the market position of the original drug
- allow innovators to earn revenue from their research and development
- encourage further pharmaceutical research and innovation
- help companies recover some of the costs involved in developing new drugs
- delay loss of exclusivity and the entry of generic competitors
- help balance innovation with wider market access once protection ends
How Long Do Drug Patents Last?
A drug patent usually runs for 20 years from its filing date. But the full period is not necessarily available after the drug is launched, since research, clinical development and approval happen during the patent term. This is why the actual drug patent expiry and the point at which generic competition begins can vary from one product to another.
Patent Expiry vs Loss of Exclusivity
A drug can have more than one layer of protection. One patent may expire while another patent or a regulatory exclusivity period is still in place.
Because of this, the drug patent expiry date and the loss of exclusivity date are not always identical. LOE is generally the more useful point when looking at when generic or biosimilar competition may begin.
Drug Patent Expiry List: Drugs Coming Off Patent By 2030
| Drug Name (Brand) | Generic Name | Company | Patent Expiry |
| Imbruvica | Ibrutinib | AbbVie / Johnson & Johnson | 2027 |
| Eliquis | Apixaban | BMS / Pfizer | 2026 |
| Keytruda | Pembrolizumab | Merck | 2028 |
| Revlimid | Lenalidomide | Bristol Myers Squibb | 2025 |
| Ibrance | Palbociclib | Pfizer | 2027 |
| Enbrel | Etanercept | Amgen | 2028 (EU), 2029 (US) |
| Opdivo | Nivolumab | Bristol Myers Squibb | 2028 |
| Trulicity | Dulaglutide | Eli Lilly | Sept 25, 2039 |
| Xarelto | Rivaroxaban | Bayer / Janssen (J&J) | 2026 |
| Eylea | Aflibercept | Regeneron / Bayer | 2025 |
| Januvia | Sitagliptin | Merck | 2025 |
| Prolia / Xgeva | Denosumab | Amgen | 2026 |
| Stelara | Ustekinumab | Johnson & Johnson | 2024 (EU), 2025 (US) |
| Dolutegravir | Dolutegravir | GSK / ViiV Healthcare | 2027 |
| Cosentyx | Secukinumab | Novartis | 2027 |
| Ozempic | Semaglutide | Novo Nordisk | Mar 20, 2026 |
| Rybelsus | Semaglutide | Novo Nordisk | Mar 20, 2026 |
| Wegovy | Semaglutide | Novo Nordisk | Mar 20, 2026 |
| Adlyxine | Lixisenatide | Sanofi | Oct 26, 2032 |
| Soliqua | Lixisenatide + Glargine | Sanofi | Oct 26, 2032 |
| Xtandi | Enzalutamide | Astellas / Pfizer | 2027 |
Top Drugs Losing Patent Protection By 2030
Over the next five years, several high-profile drugs are expected to lose patent protection. Here are some notable examples:
Imbruvica (Ibrutinib) Patent Expiration:
- 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.
Eliquis (Apixaban) Patent Expiration:
- 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.
Keytruda (Pembrolizumab) Patent Expiration:
- 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 (Lenalidomide) Patent Expiry:
- 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.
Ibrance (Palbociclib) Patent Expiration:
- 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.
Overall, Pfizer’s patent cliff is significant, as its major drugs like Eliquis, Ibrance, and Xtandi all have upcoming expirations, highlighting why tracking Pfizer major drugs patent expiry dates is crucial for market watchers.
Enbrel Patent Expiration:
- 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 (Nivolumab) Patent Expiry:
- 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 (Dulaglutide) Patent Expiration:
- 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 (Rivaroxaban) Patent Expiration:
- 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 Patent Expiration:
- 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 (Sitagliptin) Patent Expiration:
- 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 (Denosumab) Patent Expiration:
- 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 Patent Expiration:
- 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 Patent Expiry:
- 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 (Secukinumab) Patent Expiry:
- 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.
Ozempic (Semaglutide) Patent Expiration:
- Ozempic was approved by the FDA in 2017.
- It is widely used for the treatment of type 2 diabetes and has also gained popularity for weight management.
- The drug has seen a surge in demand in recent years due to its effectiveness.
- Ozempic patent expiration is expected in March 2026.
Wegovy (Semaglutide) Patent Expiration:
- Wegovy was approved by the FDA in 2021.
- It is prescribed for chronic weight management in adults with obesity or overweight who also have related health conditions.
- The drug quickly gained attention as one of the leading anti-obesity treatments worldwide.
- Wegovy patent expiration is expected in March 2026.
Xtandi (Enzalutamide) Patent Expiration:
- 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 Drug Patent Protection
Drug manufacturers may use different approaches to extend patent protection or maintain exclusivity for a longer period. Some of the common strategies include:
- 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.
GLP-1 Drugs: Data Protection and Patent Expiry
GLP-1 drugs are protected by both data exclusivity and patents. These two do not end at the same time. Data protection usually expires first. Patent protection often lasts longer and controls market entry.
For semaglutide products such as Ozempic, Wegovy, and Rybelsus, data protection is expected to end in 2026. Key patents extend slightly beyond that period. Trulicity is different. Its data protection has ended, but patent protection continues for several years. Older liraglutide products have also lost data exclusivity, though remaining patents still apply.
As a result, generic or biosimilar availability depends mainly on patent expiry, not data protection alone.
Conclusion
Patent expiry is approaching for a number of major drugs over the next few years. As these products lose exclusivity, generic and biosimilar competition may begin to change their position in the market. This makes it useful for pharmaceutical companies to keep an eye on drugs coming off patent by 2030.
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 or fill out the form here: Contact us.
FAQs
Where Can I Find Drug Patent Expiry Dates?
Drug patent expiry dates in the US can be checked through the FDA Orange Book. It lists approved drug products along with available patent and exclusivity information.
What are the Pfizer major drugs patent expiry dates?
Some of Pfizer’s major drugs approaching patent expiry include Eliquis, Ibrance, and Xtandi. These products are also part of Pfizer’s broader patent cliff, where loss of exclusivity can open the market to generic competition.
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.
Do Drug Patent Expiry Dates Differ by Country?
Yes. Drug patent expiry dates can differ from one country to another because patent rights are granted and enforced separately in each jurisdiction. A drug may therefore lose patent protection in one market while still being protected in another. For this reason, patent expiry and loss of exclusivity should be checked for the specific country or region being considered.
