Drugs losing US patent exclusivity in 2042
29 drugs face loss of exclusivity in 2042 · 29 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.
2042 is long-dated (16 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2042
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2042-12-30 | 23 patents | Method of Use |
| Daybue (TROFINETIDE) | Acadia Pharms Inc | Small molecule | 2042-07-12 | 8 patents | Method of Use |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2042-03-17 | 7 patents | Method of Use |
| Remodulin (TREPROSTINIL) | United Therap | Small molecule | 2042-02-03 | 6 patents | Method of Use |
| Velcade (bortezomib) | Shilpa | Small molecule | 2042-09-23 | 6 patents | Formulation Method of Use |
| tenapanor-hydrochloride (TENAPANOR HYDROCHLORIDE) | — | Small molecule | 2042-11-26 | 4 patents | Formulation |
| dextroamphetamine (DEXTROAMPHETAMINE) | — | Small molecule | 2042-01-06 | 4 patents | Formulation |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2042-07-29 | 4 patents | Formulation |
| Ayvakit (AVAPRITINIB) | Blueprint Medicines | Small molecule | 2042-03-08 | 3 patents | Method of Use |
| Livtencity (MARIBAVIR) | Takeda | Small molecule | 2042-11-18 | 3 patents | Method of Use |
| Otezla (APREMILAST) | Amgen | Small molecule | 2042-05-27 | 3 patents | Formulation Method of Use |
| Yorvipath (PALOPEGTERIPARATIDE) | Ascendis Pharma Bone | Small molecule | 2042-11-12 | 3 patents | Method of Use |
| vosoritide (VOSORITIDE) | — | Small molecule | 2042-07-11 | 3 patents | Method of Use |
| Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) | Innocoll | Small molecule | 2042-03-17 | 2 patents | Method of Use |
| Heparin Sodium In Plastic Container (Heparin Sodium) | Fresenius Kabi | Small molecule | 2042-04-15 | 2 patents | Composition of Matter |
| Sephience (SEPIAPTERIN) | Ptc Therap | Small molecule | 2042-03-06 | 2 patents | Method of Use |
| Tryptyr (ACOLTREMON) | Alcon Labs Inc | Small molecule | 2042-12-16 | 2 patents | Method of Use |
| Ztalmy (GANAXOLONE) | Marinus | Small molecule | 2042-09-30 | 2 patents | Method of Use |
| Alphagan (BRIMONIDINE TARTRATE) | Senju Pharmaceutical Co., Ltd | Small molecule | 2042-11-10 | 1 patents | Method of Use |
| Amoxil (amoxicillin) | Generic (originally Beecham/GSK) | Small molecule | 2042-05-27 | 1 patents | Method of Use |
| Daliresp (ROFLUMILAST) | Arcutis | Small molecule | 2042-08-19 | 1 patents | Formulation |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2042-11-05 | 1 patents | Formulation |
| Gavreto (PRALSETINIB) | Rigel Pharms | Small molecule | 2042-07-07 | 1 patents | Composition of Matter |
| Lotrimin (clotrimazole) | Bayer AG | Small molecule | 2042-05-26 | 1 patents | Method of Use |
| Nubeqa (darolutamide) | Bayer | Small molecule | 2042-06-17 | 1 patents | Formulation |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2042-09-27 | 1 patents | Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2042-04-01 | 1 patents | Method of Use |
| Welireg (BELZUTIFAN) | Merck & Co. | Small molecule | 2042-06-30 | 1 patents | Formulation |
| vibegron (VIBEGRON) | — | Small molecule | 2042-07-06 | 1 patents | Method of Use |
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 2026-05-18. Patent term extensions, supplementary protection certificates, pediatric exclusivity, and pending IPR challenges may shift the effective expiry date. Not legal advice.