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: 3

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: 4
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. BREXAFEMME

Brexafemme is a brand drug owned by Glaxosmithkline Llc. It is Used for preventing and treating recurrent and acute vulvovaginal candidiasis in adult and post-menarchal pediatric females. It was approved for market use on Jun 1, 2021. Brexafemme uses Ibrexafungerp Citrate as an active ingredient.

Total Patents: 5
Expired Patents: 0

Brexafemme's NCE-1 date is Jun 01, 2025 which is when its patents will be open to challenges.

Check the entire list of patents and their expiration dates for Brexafemme

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: 16
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: 11
Expired Patents: 3

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. 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: 14
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

8. CYTALUX

Cytalux is a brand drug owned by On Target Laboratories Inc. It is used for aiding in the intraoperative identification of malignant lesions in adult patients with ovarian cancer. It was approved for market use on Nov 29, 2021. Cytalux uses Pafolacianine Sodium as an active ingredient.

Total Patents: 6
Expired Patents: 0

Cytalux's NCE-1 date is Nov 29, 2025 which is when its patents will be open to challenges.

Check the entire list of patents and their expiration dates for Cytalux

9. EMPAVELI

Empaveli is a brand drug owned by Apellis Pharmaceuticals Inc. It is used for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by reducing sensitivity to complement-dependent damage. It was approved for market use on May 14, 2021. Empaveli uses Pegcetacoplan as an active ingredient.

Total Patents: 11
Expired Patents: 0

Empaveli's NCE-1 date is May 14, 2025 which is when its patents will be open to challenges.

Check the entire list of patents and their expiration dates for Empaveli

10. EXKIVITY

Exkivity is a brand drug owned by Takeda Pharmaceuticals Usa Inc. It is Used for treating non-small cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. It was approved for market use on Sep 15, 2021. Exkivity uses Mobocertinib Succinate as an active ingredient.

Total Patents: 2
Expired Patents: 0

Exkivity's NCE-1 date is Sep 15, 2025 which is when its patents will be open to challenges.

Check the entire list of patents and their expiration dates for Exkivity

Download full list of 40+ drugs as PDF

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