Drugs Opening to Patent Challenges in 2025
As we look ahead to 2025, significant shifts in the pharmaceutical landscape are coming. This year is crucial for several high-profile drugs as they approach their NCE-1 dates, opening the door to potential patent challenges. These challenges could pave the way for generic competition, lowering costs and increasing accessibility for patients. On this page, we highlight the drugs whose NCE-1 date lies in 2025, making them eligible for generic manufacturers to begin the process of seeking approval for alternatives. Explore the key players set to face competition and what it could mean for the market.
1. AMONDYS 45
Amondys 45 is a brand drug owned by Sarepta Therapeutics Inc. It is used for treating Duchenne Muscular Dystrophy (DMD) in patients with a mutation of the DMD gene amenable to exon 45 skipping. It was approved for market use on Feb 25, 2021. Amondys 45 uses Casimersen as an active ingredient.
Total Patents:
9
Expired Patents:
2
Amondys 45's NCE-1 date is Feb 25, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Amondys 45
2. APRETUDE
Apretude is a brand drug owned by Viiv Healthcare Co. It was approved for market use on Dec 20, 2021. Apretude uses Cabotegravir as an active ingredient.
Total Patents:
3
Expired Patents:
0
Apretude's NCE-1 date is Jan 21, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Apretude
3. AZSTARYS
Azstarys is a brand drug owned by Commave Therapeutics Sa. It is Used for managing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with Serdexmethylphenidate and Dexmethylphenidate. It was approved for market use on May 7, 2021. Azstarys uses Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride as an active ingredient.
Total Patents:
6
Expired Patents:
0
Azstarys's NCE-1 date is May 07, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Azstarys
4. BREO ELLIPTA
Breo Ellipta is a brand drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is used for the long-term maintenance treatment of airflow obstruction in patients with COPD and asthma, including chronic bronchitis and emphysema, to reduce exacerbations. It was approved for market use on May 10, 2013. Breo Ellipta uses Fluticasone Furoate; Vilanterol Trifenatate as an active ingredient.
Total Patents:
25
Expired Patents:
9
Breo Ellipta's NCE-1 date is Nov 13, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Breo Ellipta
5. BYLVAY
Bylvay is a brand drug owned by Ipsen Biopharmaceuticals Inc. It is used for reducing serum bile acids and treating pruritus in patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis. It was approved for market use on Jul 20, 2021. Bylvay uses Odevixibat as an active ingredient.
Total Patents:
12
Expired Patents:
1
Bylvay's NCE-1 date is Jul 20, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Bylvay
6. CABENUVA KIT
Cabenuva Kit is a brand drug owned by Viiv Healthcare Co. It is Used for treating HIV-1 infection in adults and adolescents aged 12 years and older. It was approved for market use on Jan 21, 2021. Cabenuva Kit uses Cabotegravir; Rilpivirine as an active ingredient.
Total Patents:
7
Expired Patents:
2
Cabenuva Kit's NCE-1 date is Jan 21, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Cabenuva Kit
7. CORLANOR
Corlanor is a brand drug owned by Amgen Inc. It is Used for treating heart failure in humans. It was approved for market use on Apr 22, 2019. Corlanor uses Ivabradine as an active ingredient.
Total Patents:
4
Expired Patents:
0
Corlanor's NCE-1 date is Oct 22, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Corlanor
8. COSELA
Cosela is a brand drug owned by Pharmacosmos As. It is Used for reducing chemotherapy-induced myelosuppression in adult patients receiving specific regimens for extensive-stage small cell lung cancer. It was approved for market use on Feb 12, 2021. Cosela uses Trilaciclib Dihydrochloride as an active ingredient.
Total Patents:
12
Expired Patents:
0
Cosela's NCE-1 date is Feb 12, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Cosela
9. COTELLIC
Cotellic is a brand drug owned by Genentech Inc. It is used for the treatment of adult patients with histiocytic neoplasms and melanoma. It was approved for market use on Nov 10, 2015. Cotellic uses Cobimetinib Fumarate as an active ingredient.
Total Patents:
13
Expired Patents:
0
Cotellic's NCE-1 date is Jan 28, 2025 which is when its patents will be open to challenges.
Check the entire list of patents and their expiration dates for Cotellic