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Top 12 Drug Patents Expiring as early as February 2025

Drug Expiry Patents

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Senior Research Analyst

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.

Download the full report covering all the drug patents expiring from 2026 to 2030. Get a deeper dive into the upcoming expirations shaping the generic drug market. Fill out the form below:

Drug Patent Expiration Report 

Drug Patent Expiration Report 

Download the Drug Expiration Report 2026-2030 in pdf:​

Xarelto

Rivaroxaban

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US7157456B2February 28, 2025New Product.
Reducing The Risk of Major Thrombotic Vascular Events; 

Pediatric Exclusivity
June 20, 2025
US9415053B2May 13, 2025
US9539218B2August 17, 2034
US10828310B2July 31, 2039

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 nameNumber of tentative approvalMonth in 2024
Apotex3October (2) and November (1)
Ascent Pharma1November
Aurobindo1October
Breckenridge Pharma1January
Dr. Reddy’s Lab1November
Invagen Pharma2January and May
Lupin1January 
Macleods Pharma1October
Prinston1June

Revlimid

Lenalidomide

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US7465800B2April 27, 2027In Combination With Rituximab For The Treatment of Patients With Previously Treated For Marginal Zone Lymphoma; May 28, 2026
US8741929B2March 08, 2028

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

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US6515117B2April 04, 2026New Patient Population; 
Pediatric Exclusivity
December 12, 2027
US8501698B2December 20, 2027
US8221786B2September 21, 2028
US8361972B2September 21, 2028
US8716251B2September 21, 2028 
US7851502B2February 19, 2029
US7919598B2June 16, 2030
US8721615B2July 18, 2030
US8685934B2November 26, 2030
US11826376B2January 18, 2040
US10973836B2September 09, 2040
US11903955B2September 09, 2040

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

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US7390791B2October 17, 2025Hiv-1 InfectionJune 18, 2026
US8754065B2February 15, 2033
US9296769B2February 15, 2033
US9216996B2December 19, 2033
US9732092B2December 19, 2033
US10385067B2June 19, 2035
US9708342B2June 19, 2035
US10548846B2|US11744802B2November 08, 2036

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

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US9474780B2January 05, 2036New Chemical Entity (NCE)May 13, 2027
US11357820B2June 14, 2039

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

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US10239867B2 | US11639347B2April 09, 2027Treatment of Cystic Fibrosis (CF)June 08, 2028
US10022352B2April 09, 2027
US8324242B2August 05, 2027
US9012496B2July 15, 2033
US11179367B2December 08, 2037

Form: Tablet
Company: Vertex Pharmaceuticals
Total sales in 2023: 9.8 Billion USD

Get detailed insights on this drug's market potential.

Xtandi

Enzalutamide

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US9126941B2May 15, 2026Treatment of Non-Metastatic Castration-Sensitive Prostate Cancer (NMCSPC)November 17, 2026
US8183274B2August 24, 2026
US7709517B2August 13, 2027
US11839689B2September 11, 2033

Form: Capsule; Tablet
Company: Astellas Pharma
Total sales in 2023: 5 Billion USD

Imbruvica

Ibrutinib

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US7514444B2|US8697711B2|US8735403B2|US8957079B2|US9181257B2June 28, 2027Treatment of Chronic Graft-Versus-Host Disease (cGVHD); 
Pediatric Exclusivity
February 24, 2030
US10653696B2December 03, 2031
US10213386B2September 03, 2036

Form: Capsule; Suspension; Tablet
Company: Pharmacyclics
Total sales in 2023: 3.5 Billion USD

Wegovy

Semaglutide

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US8536122B2March 20, 2026New Patients PopulationDecember 23, 2025
US8129343B2December 05, 2031
US9764003B2June 21, 2033
US11752198B2August 24, 2038
US10888605B2August 24, 2038
US12029779B2October 10, 2038
US11318191B2February 17, 2041

Form: Injection
Company: Novo Nordisk
Total sales in 2023: 4.4 Billion USD

Ozempic

Semaglutide

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US8114833B2August 13, 2025Addition of 3rd Maintenance Dose of SemaglutideMarch 28, 2025
US8684969B2October 20, 2025
US8536122B2March 20, 2026
US8129343B2December 05, 2031
US10335462B2June 21, 2033

Form: injection
Company: Novo Nordisk
Total sales in 2023: 13.6 Billion USD

Tagrisso

Osimertinib

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US9732058B2|US11524951B2July 25, 2032First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC)April 18, 2025
US8946235B2August 08, 2032
US10183020B2January 02, 2035

Form: Tablet
Company: AstraZeneca
Total sales in 2023: 5.7 Billion USD

Rinvoq

Upadacitinib

PatentsExpiration DateEarliest Data Exclusivity Expiring For-Expiry Date of Data Exclusivity
US8962629B2January 15, 2031Treatment of Refractory, Moderate-To-Severe Atopic DermatitisJanuary 14, 2025
US10202393B2October 17, 2036
US10550126B2October 17, 2036

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

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