Mikele Bicolli
Mar 11, 2024

Top 10 Pharmaceuticals Losing Exclusivity in the US in 2024

ANDA Litigation

As the relentless march of time continues, pharmaceutical executives find themselves facing the inevitability of patent expirations and the subsequent entry of generic or biosimilar competition. This reality underscores the imperative for continual innovation and new product launches to offset revenue losses from drugs facing the patent cliff.

In a landscape where even the most successful drugs succumb to generics or biosimilars, it's essential for companies to anticipate and strategize for such transitions. A prime example is Humira, a pharmaceutical that once boasted over $21 billion in global sales. However, as biosimilars entered the market in early 2023, Humira experienced a precipitous decline in sales.

Each year, industry observers compile lists of top drugs expected to lose exclusivity, based on factors such as U.S. sales from the previous year. In 2024, this list includes blockbusters from Bristol Myers Squibb and Biogen, alongside renowned medicines from Novo Nordisk, Astellas, and Novartis. Additionally, companies like PTC Therapeutics, Organon, and Supernus are bracing for significant potential losses of exclusivity. 

1. Sprycel (dasatinib):

Used for chronic myeloid leukemia.
Bristol Myers Squibb's exclusive rights are expiring, leading to potential generic launches in September 2024.
Settlements with Apotex and other undisclosed companies pave the way for generic entry.

2. Tysabri (natalizumab):

Treats multiple sclerosis and Crohn's disease.
Biogen's patent protection is ending, allowing Sandoz to proceed with a biosimilar launch.
Biogen aims to maintain Tysabri's role in treatment despite upcoming biosimilar competition.

3. Myrbetriq (mirabegron):

Addressing overactive bladder.
Astellas faces legal battles over patent protection.
Generic approvals from Lupin and Alkem, with expectations of launches in 2024.

4. Victoza (liraglutide):

Used for type 2 diabetes.
Novo Nordisk anticipates generic competition from Teva, Viatris, and Sandoz in June 2024.
Sales decline expected due to patent expiration and market shifts towards newer medications.

5. Emflaza (deflazacort):

Treats Duchenne muscular dystrophy.
PTC Therapeutics faces generic competition from Aurobindo following patent expiration.
Emflaza experienced a prior pricing controversy before facing generic entry.

6. Sandostatin LAR (octreotide acetate):

Addresses acromegaly and severe diarrhea from carcinoid tumors.
Novartis retains U.S. exclusivity due to manufacturing complexities despite patent expiration.
Viatris aims to launch a generic in 2024, potentially ending Novartis' exclusivity.

7. Dulera (mometasone furoate/formoterol fumarate dihydrate):

Used for asthma.
Organon expects generic competition in the second half of 2024 despite complex inhaler formulations.
Sales have declined due to competitive pricing and lower demand.

8. Oxtellar XR (oxcarbazepine):

Treats epilepsy.
Supernus Pharmaceuticals faces generic competition following patent expiration.
Expected sales decline with generic entry.

9. Venofer (iron sucrose):

Addresses iron deficiency anemia in chronic kidney disease patients.
CSL anticipates generic competition in 2024 from Viatris.
Sales figures suggest significant market impact with generic entry.

10. Prolensa (bromfenac):

Used for postoperative eye inflammation after cataract surgery.
Lupin's generic approval led to market entry in January 2024, challenging Bausch + Lomb's exclusivity.
Prolensa contributed a modest percentage of Bausch + Lomb's revenues in 2023.

Original article published by Fierce Pharma