Patent Cliff Calendar
Drugs losing US patent exclusivity in 2039
76 drugs face loss of exclusivity in 2039 · 76 small-molecule via Orange Book
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.
2039 is long-dated (13 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2039
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Mounjaro (TIRZEPATIDE) | Eli Lilly | Small molecule | 2039-06-14 | 144 patents | Composition of Matter Formulation Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2039-02-06 | 32 patents | Formulation Method of Use |
| Bylvay (ODEVIXIBAT) | Ipsen | Small molecule | 2039-06-20 | 24 patents | Composition of Matter Formulation Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2039-08-20 | 21 patents | Formulation |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2039-09-17 | 15 patents | Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2039-02-01 | 14 patents | Method of Use |
| Aristada (ARIPIPRAZOLE LAUROXIL) | Alkermes Inc | Small molecule | 2039-04-06 | 10 patents | Method of Use |
| Lioresal (BACLOFEN) | — | Small molecule | 2039-07-29 | 10 patents | Formulation Method of Use |
| Retevmo (SELPERCATINIB) | Eli Lilly | Small molecule | 2039-04-10 | 10 patents | Other |
| Rezlidhia (OLUTASIDENIB) | Rigel Pharms | Small molecule | 2039-05-16 | 9 patents | Composition of Matter Formulation Method of Use |
| Romvimza (VIMSELTINIB) | Deciphera Pharms | Small molecule | 2039-12-23 | 9 patents | Method of Use |
| lutetium-lu-177-dotatate (Lutetium Lu 177 Dotatate) | National Cancer Institute (NCI) | Small molecule | 2039-01-25 | 9 patents | Other |
| chembl-chembl2106195 (DEXMEDETOMIDINE HYDROCHLORIDE) | — | Small molecule | 2039-06-26 | 8 patents | Formulation Method of Use |
| Elucirem (GADOPICLENOL) | Guerbet | Small molecule | 2039-08-06 | 7 patents | Composition of Matter |
| Prilosec (omeprazole) | AstraZeneca (originally Astra AB) | Small molecule | 2039-07-16 | 7 patents | Formulation Method of Use |
| Invega Sustenna (PALIPERIDONE PALMITATE) | Johnson & Johnson | Small molecule | 2039-09-24 | 6 patents | Method of Use |
| Radicava (EDARAVONE) | Kk Bcj-94 | Small molecule | 2039-11-01 | 6 patents | Formulation Method of Use |
| Sodium Thiosulfate (SODIUM THIOSULFATE) | Us Army | Small molecule | 2039-07-01 | 6 patents | Formulation Method of Use |
| Xcopri (CENOBAMATE) | Sk Life | Small molecule | 2039-06-16 | 6 patents | Method of Use |
| Cellcept (MYCOPHENOLATE MOFETIL) | Roche Palo | Small molecule | 2039-08-16 | 5 patents | Formulation Method of Use |
| Angiomax (BIVALIRUDIN) | Novartis | Small molecule | 2039-05-20 | 4 patents | Formulation Method of Use |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2039-02-21 | 4 patents | Method of Use |
| Col-Probenecid (probenecid) | Pfizer Inc. | Small molecule | 2039-04-01 | 4 patents | Method of Use |
| Gavreto (PRALSETINIB) | Rigel Pharms | Small molecule | 2039-04-03 | 4 patents | Method of Use |
| Levophed (Norepinephrine Bitartrate) | Pfizer Inc. | Small molecule | 2039-04-26 | 4 patents | Formulation |
| Onfi (CLOBAZAM) | Lundbeck Pharms Llc | Small molecule | 2039-09-05 | 4 patents | Method of Use |
| tapinarof (TAPINAROF) | — | Small molecule | 2039-11-13 | 4 patents | Method of Use |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2039-02-27 | 4 patents | Other |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2039-01-25 | 4 patents | Formulation |
| Lumakras (SOTORASIB) | Amgen | Small molecule | 2039-11-18 | 3 patents | Method of Use |
| Pemazyre (PEMIGATINIB) | Incyte Corp | Small molecule | 2039-05-03 | 3 patents | Method of Use |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2039-06-06 | 3 patents | Method of Use |
| Sinemet Cr (CARBIDOPA) | Aton | Small molecule | 2039-03-28 | 3 patents | Method of Use |
| Testosterone Cypionate (Testosterone Cypionate) | Azurity | Small molecule | 2039-03-25 | 3 patents | Formulation |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2039-01-10 | 3 patents | Other |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2039-10-09 | 3 patents | Formulation |
| Yupelri (REVEFENACIN) | Mylan Ireland Ltd | Small molecule | 2039-08-29 | 3 patents | Method of Use |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2039-01-07 | 3 patents | Method of Use |
| phentolamine-mesylate (PHENTOLAMINE MESYLATE) | — | Small molecule | 2039-10-25 | 3 patents | Method of Use |
| elinzanetant (ELINZANETANT) | — | Small molecule | 2039-03-13 | 3 patents | Formulation Method of Use |
| Brinsupri (BRENSOCATIB) | Insmed Inc | Small molecule | 2039-03-01 | 2 patents | Formulation |
| Brukinsa (ZANUBRUTINIB) | BeiGene | Small molecule | 2039-06-24 | 2 patents | Method of Use |
| Diprolene (BETAMETHASONE DIPROPIONATE) | Merck & Co. | Small molecule | 2039-03-18 | 2 patents | Formulation Method of Use |
| Epidiolex (CANNABIDIOL) | Jazz Pharms Res | Small molecule | 2039-04-26 | 2 patents | Method of Use |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2039-07-18 | 2 patents | Method of Use |
| Fusilev (levoleucovorin) | Acrotech Biopharma | Small molecule | 2039-03-25 | 2 patents | Formulation |
| Lytgobi (futibatinib) | Taiho Oncology | Small molecule | 2039-11-05 | 2 patents | Formulation |
| Merrem (Meropenem) | Pfizer | Small molecule | 2039-04-06 | 2 patents | Method of Use |
| Metro I.V. In Plastic Container (METRONIDAZOLE) | Baxter | Small molecule | 2039-01-16 | 2 patents | Formulation Method of Use |
| Micro-K 10 (POTASSIUM CHLORIDE) | Nesher Pharms | Small molecule | 2039-03-07 | 2 patents | Formulation |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2039-03-08 | 2 patents | Method of Use |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2039-01-10 | 2 patents | Formulation Method of Use |
| Tavneos (AVACOPAN) | Chemocentryx | Small molecule | 2039-11-27 | 2 patents | Formulation Method of Use |
| Voranigo (VORASIDENIB) | Servier | Small molecule | 2039-01-16 | 2 patents | Method of Use |
| imetelstat-sodium (IMETELSTAT SODIUM) | — | Small molecule | 2039-06-16 | 2 patents | Method of Use |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2039-02-27 | 2 patents | Method of Use |
| pilocarpine-hydrochloride (PILOCARPINE HYDROCHLORIDE) | — | Small molecule | 2039-04-24 | 2 patents | Method of Use |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2039-03-06 | 2 patents | Method of Use |
| fosaprepitant-dimeglumine (FOSAPREPITANT DIMEGLUMINE) | — | Small molecule | 2039-01-11 | 2 patents | Formulation |
| Altace (RAMIPRIL) | King Pfizer | Small molecule | 2039-08-16 | 1 patents | Method of Use |
| Brexafemme (IBREXAFUNGERP CITRATE) | GSK | Small molecule | 2039-06-10 | 1 patents | Method of Use |
| Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container (POTASSIUM PHOSPHATE, DIBASIC) | Pfizer | Small molecule | 2039-04-19 | 1 patents | Method of Use |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2039-06-23 | 1 patents | Method of Use |
| Ekterly (SEBETRALSTAT) | Kalvista | Small molecule | 2039-01-26 | 1 patents | Method of Use |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2039-04-08 | 1 patents | Composition of Matter |
| Glucagen (GLUCAGON) | Xeris | Small molecule | 2039-09-23 | 1 patents | Formulation |
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2039-06-14 | 1 patents | Formulation |
| Inrebic (FEDRATINIB HYDROCHLORIDE) | Bristol-Myers Squibb | Small molecule | 2039-09-24 | 1 patents | Method of Use |
| Nurtec Odt (Rimegepant Sulfate) | Pfizer | Small molecule | 2039-03-25 | 1 patents | Method of Use |
| Rocuronium (Rocuronium Bromide) | Merck & Co. | Small molecule | 2039-07-22 | 1 patents | Formulation |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2039-10-11 | 1 patents | Method of Use |
| Skelaxin (METAXALONE) | Pfizer | Small molecule | 2039-07-29 | 1 patents | Formulation |
| Spy Agent Green Kit (INDOCYANINE GREEN) | Renew Pharms | Small molecule | 2039-07-14 | 1 patents | Formulation |
| Tibsovo (IVOSIDENIB) | Servier | Small molecule | 2039-06-07 | 1 patents | Method of Use |
| amlodipine-benzoate (AMLODIPINE BENZOATE) | — | Small molecule | 2039-04-11 | 1 patents | Formulation |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2039-05-24 | 1 patents | Formulation |
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.