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2026 Patent Cliff

Updated ยทnext FDA decision on the calendar

19 drugs lose patent protection in 2026. The biggest single group is Neurology & psychiatry, with 4 drugs. Losing protection does not mean a drug disappears: it means other manufacturers can apply to sell the same medicine, and the original maker usually loses most of the sales within a year or two.

This is the earliest date a generic could enter; it is not a guarantee one will. We calculate it as the later of the last patent the company listed with the FDA and the last regulatory exclusivity. Companies often reach settlement agreements with generic makers for a different date, and those agreements are not public in this data.
Nuedexta (dextromethorphan hydrobromide; quinidine)Otsuka America Pharmaceutical · 1 patent · August 13, 2026
Tekturna (aliskiren hemifumarate)LXO Ireland · 4 patents · August 19, 2026
Dymista (azelastine hydrochloride; fluticasone pr)Mylan Specialty · 2 patents · August 24, 2026
Sensipar (cinacalcet hydrochloride)Amgen · 6 patents · September 22, 2026
Sprycel (dasatinib)Bristol Myers Squibb · 12 patents · September 28, 2026
Veregen (sinecatechins)ANI Pharmaceuticals · 1 patent · October 2, 2026
Aricept (donepezil hydrochloride)Eisai · 1 patent · October 4, 2026
Saphris (asenapine maleate)Abbvie · 21 patents · October 6, 2026
Juvisync (simvastatin; sitagliptin phosphate)Merck Sharp AND Dohme · 12 patents · October 11, 2026
Androgel (testosterone)Besins Healthcare Ireland · 24 patents · October 12, 2026
Adasuve (loxapine)Nova Pneuma · 1 patent · October 23, 2026
Synribo (omacetaxine mepesuccinate)Teva Pharmaceuticals International · 1 patent · October 26, 2026
Sumavel Dosepro (sumatriptan succinate)Endo Operations · 2 patents · November 22, 2026
Naropin (ropivacaine hydrochloride)Fresenius Kabi USA · 2 patents · November 28, 2026
Clindesse (clindamycin phosphate)Padagis US · 1 patent · December 2, 2026
Protonix (pantoprazole sodium)Wyeth Pharmaceuticals · 2 patents · December 7, 2026
Corlanor (ivabradine)Amgen · 4 patents · December 12, 2026
Signifor (pasireotide diaspartate)Recordati Rare Diseases · 3 patents · December 14, 2026
Vyndaqel (tafamidis meglumine)Foldrx Pharmaceuticals LLC A Wholl · 2 patents · December 19, 2026

Questions

How many drugs lose patent protection in 2026?

19 brand-name drugs lose patent protection in 2026, per the FDA Orange Book.

What is the largest therapeutic group in the 2026 patent cliff?

Neurology & psychiatry, with 4 drugs.

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