Every year, the pharma industry anxiously watches the calendar, anticipating the moment when some of its biggest drugs face a new reality: the arrival of generic competition.
This patent cliff — when exclusivity for blockbuster medications expires — opens the door for lower-cost generics to enter the market. For patients and healthcare systems, it often means better access and affordability. But for drugmakers, it’s a critical moment that forces them to adapt to shifting revenues and more competition.
In 2025, a lineup of high-profile drugs will lose their patents, representing billions in sales and years of therapeutic innovation. From life-saving diabetes medications to essential respiratory treatments, these drugs have had a significant impact on modern care.
Here’s a closer look at the major players facing the next chapter of their respective lifecycles.
1. Glenmark Pharmaceuticals’ Ryaltris
Patent expiration: January 2025
Ryaltris, (mometasone furoate; olopatadine hydrochloride), a combination nasal spray containing a corticosteroid and an antihistamine, was approved in 2021 for the treatment of seasonal allergic rhinitis.
The drug provides dual-action relief by addressing inflammation and histamine-related symptoms, making it a key player in allergy care. For 2024, Glenmark forecased sales for the drug exceeding $80 million.
2. Cumberland Pharmaceuticals’ Sancuso
Patent expiration: January 2025
Sancuso (granisetron), approved in 2008, is a transdermal patch delivering granisetron to prevent chemotherapy-induced nausea and vomiting, offering a convenient alternative to oral medications. Its innovative delivery system has made it a valuable tool in oncology supportive care, contributing to its reported $40 million in sales in 2023.
3. Covis Pharma’s Tudorza Pressair
Patent expiration: February 2025
Tudorza Pressair, (aclidinium bromide), an anticholinergic bronchodilator for managing chronic obstructive pulmonary disease (COPD), received FDA approval in 2012.
Covis Pharma acquired the global rights to Tudorza Pressair from AstraZeneca in January 2022. In 2020, combined sales of Tudorza and Duaklir amounted to $143 million.
4. Covis Pharma’s Duaklir Pressair
Patent expiration: February 2025
Duaklir Pressair (aclidinium bromide; formoterol fumarate), combining aclidinium bromide and formoterol fumarate, was approved in 2019 for maintenance treatment of COPD. Its patent, also expiring on February 10, 2025, aligns with Tudorza Pressair, Covis Pharma’s related product.
5. AstraZeneca’s Farxiga
Patent expiration: February 2025
Blockbuster Farxiga (dapagliflozin), approved in 2014 as an SGLT2 inhibitor, addresses type 2 diabetes and has since gained indications for heart failure and chronic kidney disease. The drug belongs to a class of SGLT2-inhibitors and works by causing kidneys to expel blood sugar through urine. AstraZeneca reported $5.96 billion in sales for Farxiga in 2023, making it one of the most successful drugs in its class.
6. Boehringer Ingelheim’s Jardiance
Patent expiration: February 2025
Jardiance (empagliflozin), another SGLT2 inhibitor, was approved in 2014 for type 2 diabetes and later expanded to include heart failure and kidney disease indications. In 2023, the drug generated $8 billion in global sales. The list price of a 30-day supply of Jardiance oral tablets can vary, but typically is around $600. India-based Alembic got the nod for a generic version in 2020 but with patent disputes pending, the generic likely won’t hit the market until 2029. In February 2025, the drug will lose exclusivity relating to labeling revisions regarding clinical studies.
7. Bristol Myers Squibb’s Abilify Maintena
Patent expiration: June 2025
Abilify Maintena (aripiprazole), a long-acting injectable formulation of aripiprazole, received FDA approval in 2013 for schizophrenia and bipolar I disorder maintenance. In 2021, aripiprazole capsules ranked as the second most prescribed medication in the U.S., surpassed only by opioids. Globally, aripiprazole accounted for 44% of all antipsychotic prescriptions that year. Bristol Myers Squibb co-markets the drug with Otsuka Pharmaceutical.
8. Bayer’s Xarelto
Patent expiration: August 2025
Xarelto (rivaroxaban), a Factor Xa inhibitor approved in 2011, is widely prescribed for preventing and treating blood clots associated with atrial fibrillation and deep vein thrombosis. In 2023, Bayer reported $4.5 billion in sales for Xarelto. Last year, the drug became became one of the initial 10 medications designated for 2024 Medicare drug price negotiations in accordance with the Inflation Reduction Act (IRA).
9. Collegium Pharmaceutical’s Nucynta ER
Patent expiration: December 2025
Nucynta ER (tapentadol hydrochloride), an extended-release opioid analgesic, was approved in 2011 for the management of severe chronic pain. In 2020, Collegium acquired U.S. rights to the Nucynta franchise from Assertio Therapeutics for $375 million in cash.
