Patent Cliff Calendar
Drugs losing US patent exclusivity in 2026
118 drugs face loss of exclusivity in 2026 · 111 small-molecule via Orange Book · 7 biologic via Purple Book BPCIA
What "patent cliff" means
When a drug's primary US patent expires, generic (small molecule) or biosimilar (biologic) competitors can apply to sell copies of that drug. The originator's revenue typically erodes by 30-50% within the first year of generic entry, and 60-80% within three years. For biologics, BPCIA 12-year reference product exclusivity acts as a parallel runway alongside patent protection.
2026 is the current year — these drugs are facing loss of exclusivity now.
Drugs losing exclusivity in 2026
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2026-12-28 | 70 patents | Composition of Matter Formulation Method of Use |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2026-07-06 | 69 patents | Composition of Matter Formulation Method of Use |
| lurasidone-hydrochloride (LURASIDONE HYDROCHLORIDE) | — | Small molecule | 2026-05-26 | 35 patents | Formulation Method of Use Other |
| Androgel (TESTOSTERONE) | Besins Hlthcare | Small molecule | 2026-06-02 | 26 patents | Formulation Method of Use |
| Rexulti (BREXPIPRAZOLE) | Otsuka | Small molecule | 2026-10-12 | 24 patents | Other |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2026-07-28 | 20 patents | Formulation Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2026-07-17 | 20 patents | Formulation |
| Picato (INGENOL MEBUTATE) | Leo Labs | Small molecule | 2026-12-18 | 20 patents | Formulation Method of Use |
| bosutinib-monohydrate (BOSUTINIB MONOHYDRATE) | — | Small molecule | 2026-06-11 | 15 patents | Composition of Matter Other |
| fostamatinib-disodium (FOSTAMATINIB DISODIUM) | — | Small molecule | 2026-06-12 | 10 patents | Formulation Method of Use |
| pasireotide-pamoate (PASIREOTIDE PAMOATE) | — | Small molecule | 2026-10-25 | 10 patents | Composition of Matter Formulation |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2026-06-07 | 10 patents | Method of Use |
| Lyrica (Pregabalin) | Pfizer Inc. | Small molecule | 2026-11-02 | 9 patents | Formulation Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2026-08-27 | 9 patents | Composition of Matter Method of Use |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2026-10-31 | 9 patents | Method of Use |
| nilotinib-hydrochloride (Nilotinib Hydrochloride) | Jan Beumer | Small molecule | 2026-07-18 | 9 patents | Formulation Method of Use |
| metformin-hydrochloride (METFORMIN HYDROCHLORIDE) | — | Small molecule | 2026-07-31 | 9 patents | Formulation Method of Use |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2026-06-26 | 8 patents | Formulation Method of Use |
| Samsca (TOLVAPTAN) | Otsuka | Small molecule | 2026-09-01 | 8 patents | Composition of Matter |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2026-07-12 | 8 patents | Other |
| ivabradine-hydrochloride (IVABRADINE HYDROCHLORIDE) | — | Small molecule | 2026-08-22 | 8 patents | Method of Use Other |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2026-10-04 | 8 patents | Formulation |
| Dexilant (DEXLANSOPRAZOLE) | Takeda | Small molecule | 2026-07-17 | 7 patents | Formulation Other |
| Fycompa (PERAMPANEL) | Catalyst Pharms | Small molecule | 2026-07-01 | 7 patents | Composition of Matter |
| Prezista (DARUNAVIR) | Janssen Prods | Small molecule | 2026-12-26 | 7 patents | Composition of Matter |
| Subutex (BUPRENORPHINE) | Purdue Pharma Lp | Small molecule | 2026-07-31 | 7 patents | Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2026-05-26 | 6 patents | Other |
| Opsumit (MACITENTAN) | AstraZeneca | Small molecule | 2026-06-05 | 6 patents | Method of Use Other |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2026-11-09 | 6 patents | Formulation Method of Use |
| Sprycel (dasatinib) | Handa Therap | Small molecule | 2026-09-28 | 6 patents | Other |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2026-05-26 | 6 patents | Other |
| Vitekta (ELVITEGRAVIR) | Gilead Sciences | Small molecule | 2026-08-27 | 6 patents | Composition of Matter Method of Use |
| Zocor (simvastatin) | Merck & Co. | Small molecule | 2026-10-11 | 6 patents | Other |
| Ztalmy (GANAXOLONE) | Marinus | Small molecule | 2026-11-28 | 6 patents | Formulation Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2026-06-01 | 6 patents | Formulation |
| cinacalcet-hydrochloride (CINACALCET HYDROCHLORIDE) | — | Small molecule | 2026-09-22 | 6 patents | Formulation Method of Use |
| asenapine-maleate (ASENAPINE MALEATE) | — | Small molecule | 2026-10-06 | 6 patents | Other |
| afatinib-dimaleate (AFATINIB DIMALEATE) | — | Small molecule | 2026-07-13 | 6 patents | Method of Use Other |
| imetelstat-sodium (IMETELSTAT SODIUM) | — | Small molecule | 2026-09-09 | 6 patents | Composition of Matter Method of Use |
| Adempas (RIOCIGUAT) | Bayer | Small molecule | 2026-12-04 | 5 patents | Composition of Matter |
| Pepcid (famotidine) | Generic (originally Yamanouchi/Merck) | Small molecule | 2026-07-18 | 5 patents | Formulation Method of Use |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2026-07-11 | 5 patents | Method of Use |
| Xeljanz (Tofacitinib Citrate) | Pfizer | Small molecule | 2026-06-08 | 5 patents | Other |
| cabozantinib-s-malate (CABOZANTINIB S-MALATE) | — | Small molecule | 2026-08-14 | 5 patents | Composition of Matter |
| Bevyxxa (BETRIXABAN) | Portola Pharms Inc | Small molecule | 2026-11-07 | 4 patents | Composition of Matter Method of Use |
| Eliquis (apixaban) | Bristol-Myers Squibb | Small molecule | 2026-11-21 | 4 patents | Method of Use |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2026-08-18 | 4 patents | Method of Use |
| chembl-chembl428647 (PACLITAXEL) | — | Small molecule | 2026-08-13 | 4 patents | Method of Use Other |
| ponatinib-hydrochloride (PONATINIB HYDROCHLORIDE) | — | Small molecule | 2026-12-22 | 4 patents | Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2026-12-12 | 3 patents | Formulation |
| Kyprolis (carfilzomib) | Amgen | Small molecule | 2026-07-20 | 3 patents | Composition of Matter |
| Linzess (LINACLOTIDE) | AbbVie | Small molecule | 2026-08-30 | 3 patents | Method of Use |
| Ritalin (methylphenidate) | Novartis | Small molecule | 2026-06-05 | 3 patents | Formulation |
| Xtandi (enzalutamide) | Astellas Pharma | Small molecule | 2026-08-24 | 3 patents | Method of Use |
| Zelboraf (vemurafenib) | Hoffmann La Roche | Small molecule | 2026-06-21 | 3 patents | Composition of Matter Method of Use |
| sitagliptin-phosphate (SITAGLIPTIN PHOSPHATE) | — | Small molecule | 2026-11-24 | 3 patents | Method of Use |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2026-10-04 | 3 patents | Formulation |
| resmetirom (RESMETIROM) | — | Small molecule | 2026-09-12 | 3 patents | Composition of Matter |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2026-08-24 | 3 patents | Method of Use |
| diazoxide-choline (DIAZOXIDE CHOLINE) | — | Small molecule | 2026-12-20 | 3 patents | Composition of Matter |
| Amoxil (amoxicillin) | Generic (originally Beecham/GSK) | Small molecule | 2026-12-08 | 2 patents | Formulation Method of Use |
| Aubagio (TERIFLUNOMIDE) | Sanofi | Small molecule | 2026-09-12 | 2 patents | Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2026-08-26 | 2 patents | Other |
| Differin (ADAPALENE) | Galderma Labs Lp | Small molecule | 2026-09-15 | 2 patents | Method of Use |
| Horizant (GABAPENTIN ENACARBIL) | Azurity | Small molecule | 2026-11-10 | 2 patents | Composition of Matter |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2026-10-17 | 2 patents | Formulation Method of Use |
| Lumigan (BIMATOPROST) | — | Small molecule | 2026-12-19 | 2 patents | Formulation |
| Mitozytrex (MITOMYCIN) | Kyowa Kirin Co., Ltd. | Small molecule | 2026-07-19 | 2 patents | Formulation |
| Pantoprazole Sodium (Pantoprazole Sodium) | Pfizer | Small molecule | 2026-06-07 | 2 patents | Formulation Other |
| Spiriva (TIOTROPIUM BROMIDE) | Boehringer Ingelheim | Small molecule | 2026-07-19 | 2 patents | Formulation Other |
| Steglatro (ERTUGLIFLOZIN) | Merck & Co. | Small molecule | 2026-11-24 | 2 patents | Method of Use |
| Sustiva (EFAVIRENZ) | Bristol-Myers Squibb | Small molecule | 2026-06-13 | 2 patents | Method of Use |
| Trecondi (TREOSULFAN) | Medexus | Small molecule | 2026-10-12 | 2 patents | Method of Use |
| Vyndaqel (Tafamidis Meglumine) | Foldrx Pharms | Small molecule | 2026-12-19 | 2 patents | Composition of Matter Method of Use |
| Vyndaqel (tafamidis) | Foldrx Pharms | Small molecule | 2026-12-19 | 2 patents | Composition of Matter Method of Use |
| sugammadex-sodium (SUGAMMADEX SODIUM) | — | Small molecule | 2026-07-27 | 2 patents | Other |
| elacestrant-hydrochloride (ELACESTRANT HYDROCHLORIDE) | — | Small molecule | 2026-08-18 | 2 patents | Method of Use |
| ropivacaine-hydrochloride (ROPIVACAINE HYDROCHLORIDE) | — | Small molecule | 2026-11-28 | 2 patents | Formulation |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2026-05-30 | 2 patents | Composition of Matter |
| Acetadote (Acetylcysteine) | Bristol-Myers Squibb | Small molecule | 2026-05-21 | 1 patents | Formulation |
| Adasuve (LOXAPINE) | — | Small molecule | 2026-10-23 | 1 patents | Formulation |
| Beleodaq (belinostat) | Acrotech Biopharma | Small molecule | 2026-08-10 | 1 patents | Method of Use |
| Calquence (ACALABRUTINIB) | AstraZeneca | Small molecule | 2026-11-24 | 1 patents | Composition of Matter |
| Cleocin T (CLINDAMYCIN PHOSPHATE) | Pfizer | Small molecule | 2026-12-02 | 1 patents | Method of Use |
| Corlanor (IVABRADINE) | Amgen | Small molecule | 2026-12-12 | 1 patents | Method of Use |
| Cytarabine (Cytarabine) | Nippon Shinyaku Co., Ltd. | Small molecule | 2026-06-07 | 1 patents | Formulation |
| Dovonex (CALCIPOTRIENE) | — | Small molecule | 2026-05-26 | 1 patents | Method of Use |
| Ecclock (SOFPIRONIUM BROMIDE) | Kaken Pharmaceutical | Small molecule | 2026-11-13 | 1 patents | Method of Use |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2026-11-29 | 1 patents | Method of Use |
| Epanova (OMEGA-3-CARBOXYLIC ACIDS) | AstraZeneca | Small molecule | 2026-12-20 | 1 patents | Formulation |
| Hernexeos (ZONGERTINIB) | Boehringer Ingelheim | Small molecule | 2026-11-15 | 1 patents | Composition of Matter |
| Inrebic (FEDRATINIB HYDROCHLORIDE) | Bristol-Myers Squibb | Small molecule | 2026-12-16 | 1 patents | Composition of Matter |
| Jevtana Kit (cabazitaxel) | Accord Hlthcare | Small molecule | 2026-06-10 | 1 patents | Other |
| Lignospan Forte (Lidocaine Hydrochloride) | Fresenius Kabi | Small molecule | 2026-07-24 | 1 patents | Method of Use |
| Nexplanon (ETONOGESTREL) | — | Small molecule | 2026-08-28 | 1 patents | Formulation |
| Osphena (OSPEMIFENE) | Duchesnay | Small molecule | 2026-08-11 | 1 patents | Method of Use |
| Ovide (MALATHION) | Taro | Small molecule | 2026-08-14 | 1 patents | Formulation |
| Synribo (OMACETAXINE MEPESUCCINATE) | Teva Pharms Intl | Small molecule | 2026-10-26 | 1 patents | Method of Use |
| Topicort (DESOXIMETASONE) | Taro | Small molecule | 2026-05-26 | 1 patents | Method of Use |
| Torisel (temsirolimus) | Pfizer | Small molecule | 2026-07-20 | 1 patents | Other |
| Xeglyze (ABAMETAPIR) | Hatchtech | Small molecule | 2026-10-28 | 1 patents | Method of Use |
| azelastine-hydrochloride (AZELASTINE HYDROCHLORIDE) | — | Small molecule | 2026-08-24 | 1 patents | Other |
| olodaterol-hydrochloride (OLODATEROL HYDROCHLORIDE) | — | Small molecule | 2026-10-10 | 1 patents | Formulation |
| albuterol-sulfate (ALBUTEROL SULFATE) | — | Small molecule | 2026-10-10 | 1 patents | Formulation |
| dextromethorphan-hydrobromide (DEXTROMETHORPHAN HYDROBROMIDE) | — | Small molecule | 2026-08-13 | 1 patents | Method of Use |
| sinecatechins (SINECATECHINS) | — | Small molecule | 2026-10-02 | 1 patents | Method of Use |
| donepezil-hydrochloride (DONEPEZIL HYDROCHLORIDE) | — | Small molecule | 2026-10-04 | 1 patents | Formulation |
| elinzanetant (ELINZANETANT) | — | Small molecule | 2026-09-15 | 1 patents | Composition of Matter |
| histrelin-acetate (HISTRELIN ACETATE) | — | Small molecule | 2026-06-16 | 1 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2026-08-16 | 1 patents | Formulation |
| avacincaptad-pegol-sodium (AVACINCAPTAD PEGOL SODIUM) | — | Small molecule | 2026-11-11 | 1 patents | Method of Use |
| AFREZZA (INSULIN HUMAN) | MANNKIND | Biologic | 2026-06-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BLINCYTO (blinatumomab) | Amgen | Biologic | 2026-12-03 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENTYVIO (vedolizumab) | Takeda | Biologic | 2026-05-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Keytruda (pembrolizumab) | Merck & Co. | Biologic | 2026-09-04 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Opdivo (nivolumab) | Bristol-Myers Squibb | Biologic | 2026-12-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PLEGRIDY PEN (PEGINTERFERON BETA-1A) | Biogen Idec Inc | Biologic | 2026-08-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TRULICITY (DULAGLUTIDE) | Eli Lilly | Biologic | 2026-09-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
Sources
- FDA Orange Book — patents listed against approved small-molecule drugs (NDAs).
- FDA Purple Book — BPCIA 12-year reference product exclusivity for licensed biologics (BLAs).
- USPTO PatentsView + Google Patents — title, abstract, and claim text grounding.
- Drug Landscape — AI-augmented enrichment and consolidated estate analysis.
Data shown is sourced from public regulatory and patent databases as of 2026-05-17. Patent term extensions, supplementary protection certificates, pediatric exclusivity, and pending IPR challenges may shift the effective expiry date. Not legal advice.