Several high-value drug patents are expiring as early as February 2025, along with their data exclusivities. The list includes Farxiga, Mounjaro, and Ozempic, opening a window for generic developers to strategically target high-value drugs.
GreyB analyzed all the drug patents expiring between 2025 and 2040 and spotted the top 12 high-value drugs. The analysis highlights:
- Patent and data exclusivity expiration details.
- Market leaders like Eli Lilly and their expansion plans.
- Key insights of top 5 drugs to prioritize your development pipeline.
Get a deeper dive into the Top Blockbuster drugs expiring and the key opportunities for generic drug makers. Fill out the form below to download the report:
Xarelto
Rivaroxaban
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US7157456B2 | February 28, 2025 | New Product.Reducing The Risk of Major Thrombotic Vascular Events; Pediatric Exclusivity | Molecule | June 20, 2025 |
| US9415053B2 | May 13, 2025 | Method of preparation of formulation | ||
| US9539218B2 | August 17, 2034 | Dosage regimen | ||
| US10828310B2 | July 31, 2039 | Combinational regimen |
Form: Suspension; Tablet
Company: Janssen Pharmaceuticals
Total sales in 2023: 4.4 Billion USD
The Xarelto molecule patent was initially set to expire in August 2024. Interestingly, it has received an additional six-month extension due to pediatric exclusivity. The drug patent is now expiring in February 2025. Generic companies must wait until next month to introduce their generic versions in the U.S. market.
Other patents in the Orange Book protect the dosage and combination regimen of Rivaroxaban with Aspirin until 2034 and 2039, respectively. Generic manufacturers will have to wait for these patents to expire before launching their versions related to single and combination Rivaroxaban dosage regimens.
The following companies have already received tentative ANDA approval for generic Rivaroxaban, positioning them to potentially launch their products after the molecule patent expires in February 2025.
| Company name | Number of tentative approval | Month in 2024 |
| Apotex | 3 | October (2) and November (1) |
| Ascent Pharma | 1 | November |
| Aurobindo | 1 | October |
| Breckenridge Pharma | 1 | January |
| Dr. Reddy’s Lab | 1 | November |
| Invagen Pharma | 2 | January and May |
| Lupin | 1 | January |
| Macleods Pharma | 1 | October |
| Prinston | 1 | June |
Revlimid
Lenalidomide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US7465800B2 | April 27, 2027 | In Combination With Rituximab For The Treatment of Patients With Previously Treated For Marginal Zone Lymphoma; | Crystalline form | May 28, 2026 |
| US8741929B2 | March 08, 2028 | Dosage regimen |
Form: Capsule
Company: Bristol Myers Squibb
Total sales in 2023: 6 Billion USD
The upcoming 1.5 years present an excellent opportunity for generic companies to establish their strategies for developing generic Lenalidomide. It can be combined with Rituximab to treat marginal zone lymphoma (MZL). Companies like Cipla and Sun Pharma have already settled patent litigation with BMS and Celgene regarding the generic version of Lenalidomide in the US.
As a result of these settlements, they are selling a limited quantity of the generic version starting from March 2022. Moreover, the settlement grants Sun Pharma and Cipla the right to manufacture and sell an unlimited amount of generic Lenalidomide capsules beginning January 31, 2026.
Several other generic manufacturers are actively engaged in developing lenalidomide. These include Dr. Reddy’s Laboratories, Delphis Pharma, Sandoz, Reliance Life Sciences, Teva, Hetero Healthcare, Deva Pharma, and Synton.
The existing patents remain in effect and may challenge your generic development efforts. It is crucial to monitor these patents closely before launching your generic version.
Get instant alerts for expiring drug patents that will impact your generic launch. From the Notice of Allowance, Abandoned, and Oppositions to NCE1, Elixir covers different regulations by USPTO, EPO, and Orange Book.
Monitor Revlimid’s patent activity on Elixir.
Farxiga
Dapagliflozin
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US6515117B2 | April 04, 2026 | New Patient Population; Pediatric Exclusivity | New Patient Population; | December 12, 2027 |
| US8501698B2 | December 20, 2027 | Pediatric Exclusivity | ||
| US8221786B2 | September 21, 2028 | Oral formulation | ||
| US8361972B2 | September 21, 2028 | Dosage regimen | ||
| US8716251B2 | September 21, 2028 | Oral formulation | ||
| US7851502B2 | February 19, 2029 | Oral formulation | ||
| US7919598B2 | June 16, 2030 | Crystalline solvate | ||
| US8721615B2 | July 18, 2030 | Container | ||
| US8685934B2 | November 26, 2030 | Dosage regimen (condition) | ||
| US11826376B2 | January 18, 2040 | Dosage regimen (condition) | ||
| US10973836B2 | September 09, 2040 | Method of use | ||
| US11903955B2 | September 09, 2040 | Dosage regimen (condition) |
Form: Capsule
Company: AstraZeneca
Total sales in 2023: 5.9 Billion USD
In 2023, the SGLT2 inhibitors market reached a significant size of USD 15.85 billion. Farxiga (Dapagliflozin) took the lead by capturing 40% of sales for AstraZeneca. The molecule patent of this drug is expiring in the next 16 months.
AstraZeneca has strategically enhanced Farxiga’s market presence by securing approval for its use in pediatric patients with type 2 diabetes aged 10 and above. This aims to extend the product’s lifecycle in the changing markets.
Biktarvy
Bictegravir, Emtricitabine, Tenofovir alafenamide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US7390791B2 | October 17, 2025 | Hiv-1 Infection | Isomeric form of Tenofovir alafenamide | June 18, 2026 |
| US8754065B2 | February 15, 2033 | Ester form of Tenofovir | ||
| US9296769B2 | February 15, 2033 | Composition | ||
| US9216996B2 | December 19, 2033 | Molecule (Bictegravir) | ||
| US9732092B2 | December 19, 2033 | Molecule (Bictegravir) | ||
| US10385067B2 | June 19, 2035 | Method of use | ||
| US9708342B2 | June 19, 2035 | Molecule (Bictegravir) | ||
| US10548846B2|US11744802B2 | November 08, 2036 | Oral combination formulation |
Form: Tablet
Company: Gilead Sciences
Total sales in 2023: 11.8 Billion USD
Biktarvy’s exclusivity for HIV-1 infection will end in the next 1.5 years. However, the drug’s molecule patent is expiring in 2033. It’s important to note that Gilead is fortifying its position in the HIV treatment arena. The company has secured FDA approval for an updated label that highlights Biktarvy’s safety and efficacy in treating pregnant individuals with HIV-1.
Looking ahead, Gilead has laid out a plan to extend its HIV dominance into the next decade and beyond. At the forefront of this strategy is Lenacapivir, which is a treatment for multidrug-resistant HIV. Clinical trials show promising results, with over 99.5% of participants not contracting HIV after receiving Lenacapivir.
Beyond Lenacapivir, Gilead is developing seven new treatments, encompassing 12 new molecules and 11 combination therapies. These measures ensure that Gilead remains a formidable force in the HIV treatment landscape for years to come.
Mounjaro
Tirzepatide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US9474780B2 | January 05, 2036 | New Chemical Entity (NCE) | Molecule | May 13, 2027 |
| US11357820B2 | June 14, 2039 | Injectable formulation |
Form: Injection
Company: Eli Lilly
Total sales in 2023: 5.1 Billion USD
Mounjaro’s new chemical entity (NCE) exclusivity is set to expire in 2027. This expiration will allow access to its regulatory data. Generic manufacturers can access bioequivalence studies and develop their versions. This strategy will help you to be the first to file the ANDA after the expiry of specific periods.
Eli Lilly’s Mounjaro has already surpassed Novo Nordisk’s Wegovy, capturing 70% of the weight loss market sales in the UK. As Lilly continues its global expansion, the company has announced its impending entry into the Indian market in 2025. This could create a potential goldmine for manufacturing companies interested in licensing or collaborating on Mounjaro’s production and sale.
Moreover, Lilly has already established partnerships in India, such as with Cipla for Humalog and Trulicity and with Lupin for the Huminsulin range products, alongside contract manufacturing with Gland Pharma for insulin vials. Industry watchers are keen to see which company will secure a collaboration to manufacture Mounjaro in India next year, marking the next chapter in this unfolding narrative.
Trikafta
Elexacaftor, Tezacaftor, Ivacaftor and Ivacaftor
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US10239867B2 | US11639347B2 | April 09, 2027 | Treatment of Cystic Fibrosis (CF) | Molecule | June 08, 2028 |
| US10022352B2 | April 09, 2027 | Oral formulation | ||
| US8324242B2 | August 05, 2027 | Method of use | ||
| US9012496B2 | July 15, 2033 | Combination dosage regimen | ||
| US11179367B2 | December 08, 2037 | Combination oral formulation |
Form: Tablet
Company: Vertex Pharmaceuticals
Total sales in 2023: 9.8 Billion USD
Get detailed insights on this drug's market potential.
Xtandi
Enzalutamide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US9126941B2 | May 15, 2026 | Treatment of Non-Metastatic Castration-Sensitive Prostate Cancer (NMCSPC) | Method of use | November 17, 2026 |
| US8183274B2 | August 24, 2026 | Method of use | ||
| US7709517B2 | August 13, 2027 | Molecule | ||
| US11839689B2 | September 11, 2033 | Oral formulation |
Form: Capsule; Tablet
Company: Astellas Pharma
Total sales in 2023: 5 Billion USD
Imbruvica
Ibrutinib
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US7514444B2|US8697711B2|US8735403B2|US8957079B2|US9181257B2 | June 28, 2027 | Treatment of Chronic Graft-Versus-Host Disease (cGVHD); Pediatric Exclusivity | Molecule | February 24, 2030 |
| US10653696B2 | December 03, 2031 | Dosage regimen | ||
| US10213386B2 | September 03, 2036 | Oral formulation |
Form: Capsule; Suspension; Tablet
Company: Pharmacyclics
Total sales in 2023: 3.5 Billion USD
Wegovy
Semaglutide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US8536122B2 | March 20, 2026 | New Patients Population | Molecule | December 23, 2025 |
| US8129343B2 | December 05, 2031 | Molecule | ||
| US9764003B2 | June 21, 2033 | Dosage regimen | ||
| US11752198B2 | August 24, 2038 | Injectable formulation | ||
| US10888605B2 | August 24, 2038 | Injectable formulation | ||
| US12029779B2 | October 10, 2038 | Dosage regimen | ||
| US11318191B2 | February 17, 2041 | Injectable formulation |
Form: Injection
Company: Novo Nordisk
Total sales in 2023: 4.4 Billion USD
Ozempic
Semaglutide
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US8114833B2 | August 13, 2025 | Addition of 3rd Maintenance Dose of Semaglutide | Injectable formulation | March 28, 2025 |
| US8684969B2 | October 20, 2025 | Device | ||
| US8536122B2 | March 20, 2026 | Molecule | ||
| US8129343B2 | December 05, 2031 | Molecule | ||
| US10335462B2 | June 21, 2033 | Dosage regimen |
Form: injection
Company: Novo Nordisk
Total sales in 2023: 13.6 Billion USD
Tagrisso
Osimertinib
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US9732058B2|US11524951B2 | July 25, 2032 | First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) | Molecule | April 18, 2025 |
| US8946235B2 | August 08, 2032 | Molecule | ||
| US10183020B2 | January 02, 2035 | Oral formulation |
Form: Tablet
Company: AstraZeneca
Total sales in 2023: 5.7 Billion USD
Rinvoq
Upadacitinib
| Patents | Expiration Date | Earliest Data Exclusivity Expiring For- | Categorization | Expiry Date of Data Exclusivity |
| US8962629B2 | January 15, 2031 | Treatment of Refractory, Moderate-To-Severe Atopic Dermatitis | Molecule | January 14, 2025 |
| US10202393B2 | October 17, 2036 | Oral formulation | ||
| US10550126B2 | October 17, 2036 | Dosage regimen |
Form: Tablet
Company: Abbvie
Total sales in 2023: 3.9 Billion USD
Future Outlook
The upcoming expirations of data exclusivity of Tirzepatide (NCE exclusivity expiring in May 2027) and Dapagliflozin (molecule patent expiring in April 2026) will allow cost-effective alternatives to enter this rapidly growing space. With the demand for affordable diabetes treatments rising, this is the moment to invest, innovate, and secure your place in this transformative market. Companies like MSN laboratories, Lupin, and Glenmark have already received tentative approval for the generic version of Dapagliflozin. They can launch their version right after the expiry of their patents.
To lead the generic market, pharmaceutical companies must establish R&D pipelines, initiate bioequivalence studies, and prepare for regulatory submissions.
Monitoring expiring drug patents will protect you from litigation that could jeopardize your generic development efforts. Elixir supports this by tracking various regulations, from the Notice of Allowance, Abandoned, and Oppositions to NCE1, across USPTO, EPO, and Orange Book.
Get instant alerts for patent lifecycle events that will impact your generic launch.
Authored by: Shadab Riyaz, Patent Search
