Patent Cliff Calendar
Drugs losing US patent exclusivity in 2038
83 drugs face loss of exclusivity in 2038 · 73 small-molecule via Orange Book · 10 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.
2038 is long-dated (12 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2038
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2038-03-15 | 44 patents | Formulation Method of Use Other |
| Retevmo (SELPERCATINIB) | Eli Lilly | Small molecule | 2038-04-10 | 28 patents | Method of Use Other |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2038-08-24 | 23 patents | Method of Use |
| Levophed (Norepinephrine Bitartrate) | Pfizer Inc. | Small molecule | 2038-01-30 | 21 patents | Formulation Method of Use |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2038-03-23 | 20 patents | Formulation |
| Jesduvroq (DAPRODUSTAT) | GSK | Small molecule | 2038-03-13 | 10 patents | Method of Use |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2038-06-01 | 10 patents | Method of Use |
| lutetium-lu-177-dotatate (Lutetium Lu 177 Dotatate) | National Cancer Institute (NCI) | Small molecule | 2038-07-25 | 9 patents | Formulation Method of Use |
| Xdemvy (LOTILANER) | Tarsus | Small molecule | 2038-12-14 | 8 patents | Formulation Method of Use |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2038-01-26 | 8 patents | Formulation |
| Caduet (Amlodipine Besylate) | Pfizer Inc. | Small molecule | 2038-01-23 | 7 patents | Formulation Method of Use |
| Barhemsys (AMISULPRIDE) | Acacia | Small molecule | 2038-02-09 | 6 patents | Method of Use |
| Ferriprox (DEFERIPRONE) | Chiesi | Small molecule | 2038-10-25 | 6 patents | Formulation Method of Use |
| Invega Sustenna (PALIPERIDONE PALMITATE) | Johnson & Johnson | Small molecule | 2038-10-26 | 6 patents | Method of Use |
| Nimotop (NIMODIPINE) | — | Small molecule | 2038-04-16 | 6 patents | Formulation Method of Use |
| Rinvoq (upadacitinib) | AbbVie Inc. | Small molecule | 2038-03-09 | 6 patents | Method of Use |
| Sephience (SEPIAPTERIN) | Ptc Therap | Small molecule | 2038-04-16 | 6 patents | Method of Use |
| Tukysa (tucatinib) | Seagen | Small molecule | 2038-04-27 | 6 patents | Method of Use |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2038-09-25 | 6 patents | Formulation |
| pexidartinib-hydrochloride (PEXIDARTINIB HYDROCHLORIDE) | — | Small molecule | 2038-07-24 | 6 patents | Formulation Method of Use |
| lazertinib-mesylate (LAZERTINIB MESYLATE) | — | Small molecule | 2038-04-18 | 6 patents | Composition of Matter Formulation Method of Use |
| Viagra (Sildenafil Citrate) | Pfizer Inc. | Small molecule | 2038-12-24 | 5 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2038-10-25 | 5 patents | Formulation |
| Cialis (tadalafil) | Eli Lilly | Small molecule | 2038-12-24 | 4 patents | Method of Use |
| Cubicin (Daptomycin) | Baxter | Small molecule | 2038-08-28 | 4 patents | Formulation Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2038-02-06 | 4 patents | Formulation Method of Use |
| Evrysdi (RISDIPLAM) | Roche | Small molecule | 2038-10-01 | 4 patents | Method of Use |
| Itovebi (INAVOLISIB) | Genentech Inc | Small molecule | 2038-04-26 | 4 patents | Composition of Matter Method of Use |
| Jascayd (NERANDOMILAST) | Boehringer Ingelheim | Small molecule | 2038-10-22 | 4 patents | Method of Use |
| Posluma (FLOTUFOLASTAT F-18 GALLIUM) | Blue Earth | Small molecule | 2038-08-23 | 4 patents | Composition of Matter Method of Use |
| Ranexa (RANOLAZINE) | Menarini Intl | Small molecule | 2038-01-24 | 4 patents | Formulation |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2038-07-18 | 4 patents | Formulation |
| Tryvio (APROCITENTAN) | Idorsia | Small molecule | 2038-02-26 | 4 patents | Composition of Matter Formulation Method of Use |
| donepezil-hydrochloride (DONEPEZIL HYDROCHLORIDE) | — | Small molecule | 2038-05-20 | 4 patents | Method of Use |
| elacestrant-hydrochloride (ELACESTRANT HYDROCHLORIDE) | — | Small molecule | 2038-01-05 | 4 patents | Composition of Matter Method of Use |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2038-08-27 | 4 patents | Formulation Method of Use |
| eltrombopag-choline (ELTROMBOPAG CHOLINE) | — | Small molecule | 2038-11-05 | 4 patents | Method of Use |
| Balversa (ERDAFITINIB) | Johnson & Johnson | Small molecule | 2038-02-02 | 3 patents | Method of Use |
| Klisyri (TIRBANIBULIN) | Almirall | Small molecule | 2038-03-12 | 3 patents | Composition of Matter Method of Use |
| Lumakras (SOTORASIB) | Amgen | Small molecule | 2038-05-21 | 3 patents | Composition of Matter |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2038-08-22 | 3 patents | Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2038-05-18 | 3 patents | Formulation Method of Use |
| Ritalin (methylphenidate) | Novartis | Small molecule | 2038-01-25 | 3 patents | Method of Use |
| Sincalide (SINCALIDE) | Bracco | Small molecule | 2038-04-20 | 3 patents | Method of Use |
| Tymlos (ABALOPARATIDE) | Radius | Small molecule | 2038-04-30 | 3 patents | Formulation Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2038-07-10 | 3 patents | Formulation Method of Use |
| Xolremdi (MAVORIXAFOR) | X4 Pharms | Small molecule | 2038-12-11 | 3 patents | Formulation |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2038-08-30 | 3 patents | Formulation |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2038-07-12 | 2 patents | Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2038-04-30 | 2 patents | Method of Use |
| Lorbrena (lorlatinib) | Pfizer | Small molecule | 2038-10-04 | 2 patents | Composition of Matter |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2038-10-05 | 2 patents | Formulation |
| Retin-A (TRETINOIN) | Bausch Health | Small molecule | 2038-08-22 | 2 patents | Method of Use |
| Versed (midazolam) | Generic (originally Roche) | Small molecule | 2038-06-20 | 2 patents | Formulation |
| Vocabria (CABOTEGRAVIR) | GSK | Small molecule | 2038-07-18 | 2 patents | Method of Use |
| Ycanth (CANTHARIDIN) | Verrica Pharms | Small molecule | 2038-08-22 | 2 patents | Method of Use |
| danicopan (DANICOPAN) | — | Small molecule | 2038-08-02 | 2 patents | Method of Use |
| tapinarof (TAPINAROF) | — | Small molecule | 2038-11-13 | 2 patents | Composition of Matter |
| Cipro (Ciprofloxacin) | Alk Abello | Small molecule | 2038-11-27 | 1 patents | Formulation |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2038-09-03 | 1 patents | Formulation |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2038-05-03 | 1 patents | Method of Use |
| Komzifti (ZIFTOMENIB) | Kura | Small molecule | 2038-09-06 | 1 patents | Method of Use |
| Leustatin (CLADRIBINE) | — | Small molecule | 2038-11-23 | 1 patents | Method of Use |
| Merrem (Meropenem) | Pfizer | Small molecule | 2038-01-08 | 1 patents | Method of Use |
| Nubeqa (darolutamide) | Bayer | Small molecule | 2038-02-27 | 1 patents | Composition of Matter |
| Reglan (Metoclopramide Hydrochloride) | Hikma | Small molecule | 2038-11-17 | 1 patents | Method of Use |
| Renacidin (CITRIC ACID) | Baxter | Small molecule | 2038-01-27 | 1 patents | Formulation |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2038-11-20 | 1 patents | Method of Use |
| Sodium Thiosulfate (SODIUM THIOSULFATE) | Us Army | Small molecule | 2038-01-05 | 1 patents | Method of Use |
| Subutex (BUPRENORPHINE) | Purdue Pharma Lp | Small molecule | 2038-06-22 | 1 patents | Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2038-07-19 | 1 patents | Method of Use |
| Zavesca (MIGLUSTAT) | AstraZeneca | Small molecule | 2038-09-16 | 1 patents | Method of Use |
| sufentanil-citrate (SUFENTANIL CITRATE) | — | Small molecule | 2038-02-02 | 1 patents | Formulation |
| AVLAYAH (TIVIDENOFUSP ALFA-EKNM) | DENALI THERAPEUTICS INC. | Biologic | 2038-03-24 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AWIQLI | NOVO NORDISK INC | Biologic | 2038-03-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LOARGYS (PEGZILARGINASE-NBLN) | IMMEDICA PHARMA AB | Biologic | 2038-02-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYBREVANT FASPRO | JANSSEN BIOTECH | Biologic | 2038-02-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SAPHNELO (ANIFROLUMAB) | AstraZeneca | Biologic | 2038-04-24 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ACCORD BIOPHARMA INC. | Biologic | 2038-05-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ACCORD BIOPHARMA INC. | Biologic | 2038-01-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | CELLTRION INC | Biologic | 2038-01-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | TEVA PHARMACEUTICALS, INC. | Biologic | 2038-03-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SUNSHINE LAKE PHARMA CO LTD | Biologic | 2038-04-29 | 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.