Patent Cliff Calendar
Drugs losing US patent exclusivity in 2028
146 drugs face loss of exclusivity in 2028 · 131 small-molecule via Orange Book · 15 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.
2028 is a near-term cliff (2 years away). Biosimilar / generic filers are preparing IPR petitions and 351(k) / ANDA filings now.
Drugs losing exclusivity in 2028
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Remodulin (TREPROSTINIL) | United Therap | Small molecule | 2028-03-10 | 50 patents | Composition of Matter Formulation Method of Use |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2028-03-21 | 34 patents | Formulation Method of Use Other |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2028-02-05 | 34 patents | Formulation Method of Use Other |
| Sinemet Cr (CARBIDOPA) | Aton | Small molecule | 2028-12-26 | 32 patents | Formulation Method of Use |
| Prograf (TACROLIMUS) | Astellas Pharma | Small molecule | 2028-05-30 | 30 patents | Formulation Method of Use |
| Invokana (CANAGLIFLOZIN) | Johnson & Johnson | Small molecule | 2028-01-14 | 20 patents | Other |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2028-08-01 | 16 patents | Composition of Matter |
| Aptiom (ESLICARBAZEPINE ACETATE) | Sumitomo Pharma Am | Small molecule | 2028-09-13 | 12 patents | Formulation Method of Use |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2028-02-13 | 12 patents | Formulation Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2028-10-06 | 11 patents | Method of Use |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2028-07-10 | 11 patents | Composition of Matter Formulation Method of Use |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2028-07-08 | 10 patents | Composition of Matter Formulation Method of Use |
| fentanyl-citrate (FENTANYL CITRATE) | — | Small molecule | 2028-06-15 | 10 patents | Formulation |
| doxepin-hydrochloride (DOXEPIN HYDROCHLORIDE) | — | Small molecule | 2028-01-18 | 10 patents | Formulation Method of Use |
| Rayaldee (CALCIFEDIOL) | — | Small molecule | 2028-04-25 | 8 patents | Formulation Method of Use |
| Viberzi (ELUXADOLINE) | AbbVie | Small molecule | 2028-07-07 | 8 patents | Method of Use |
| chembl-chembl2103744 (MORPHINE SULFATE) | — | Small molecule | 2028-08-12 | 8 patents | Formulation |
| Elucirem (GADOPICLENOL) | Guerbet | Small molecule | 2028-09-19 | 7 patents | Composition of Matter |
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2028-05-13 | 7 patents | Other |
| Kybella (DEOXYCHOLIC ACID) | AbbVie | Small molecule | 2028-02-21 | 7 patents | Composition of Matter Formulation Method of Use |
| Otezla (APREMILAST) | Amgen | Small molecule | 2028-02-16 | 7 patents | Composition of Matter Other |
| ferric-oxyhydroxide (FERRIC OXYHYDROXIDE) | — | Small molecule | 2028-11-13 | 7 patents | Formulation |
| milsaperidone (Milsaperidone) | Vanda Pharmaceuticals | Small molecule | 2028-03-28 | 7 patents | Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2028-12-16 | 6 patents | Formulation |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2028-02-03 | 6 patents | Formulation Method of Use |
| Dificid (FIDAXOMICIN) | Cubist Pharms Llc | Small molecule | 2028-01-31 | 6 patents | Other |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2028-03-12 | 6 patents | Formulation |
| Jublia (EFINACONAZOLE) | Bausch Health | Small molecule | 2028-01-03 | 6 patents | Formulation Method of Use |
| Revlimid (lenalidomide) | Bristol-Myers Squibb | Small molecule | 2028-03-08 | 6 patents | Method of Use |
| Rexulti (BREXPIPRAZOLE) | Otsuka | Small molecule | 2028-12-23 | 6 patents | Composition of Matter |
| vadadustat (VADADUSTAT) | — | Small molecule | 2028-03-13 | 6 patents | Composition of Matter Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2028-03-12 | 6 patents | Formulation |
| nilotinib-hydrochloride (Nilotinib Hydrochloride) | Jan Beumer | Small molecule | 2028-03-25 | 6 patents | Composition of Matter Other |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2028-06-03 | 6 patents | Composition of Matter Other |
| Jesduvroq (DAPRODUSTAT) | GSK | Small molecule | 2028-12-11 | 5 patents | Composition of Matter |
| OxyContin (oxycodone) | Purdue Pharma | Small molecule | 2028-10-09 | 5 patents | Formulation |
| Winlevi (CLASCOTERONE) | Sun Pharma | Small molecule | 2028-07-24 | 5 patents | Formulation Method of Use |
| pasireotide-pamoate (PASIREOTIDE PAMOATE) | — | Small molecule | 2028-05-23 | 5 patents | Formulation |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2028-10-11 | 5 patents | Formulation |
| Afinitor (everolimus) | Novartis | Small molecule | 2028-07-01 | 4 patents | Method of Use |
| Aloprim (ALLOPURINOL) | Casper Pharma Llc | Small molecule | 2028-11-26 | 4 patents | Method of Use |
| Dexilant (DEXLANSOPRAZOLE) | Takeda | Small molecule | 2028-01-11 | 4 patents | Formulation Other |
| Injectafer (FERRIC CARBOXYMALTOSE) | Am Regent | Small molecule | 2028-02-15 | 4 patents | Method of Use |
| Inpefa (SOTAGLIFLOZIN) | Lexicon Pharms Inc | Small molecule | 2028-05-04 | 4 patents | Method of Use |
| Marinol (DRONABINOL) | Wellhouse Pharma | Small molecule | 2028-08-06 | 4 patents | Composition of Matter |
| Omnaris (CICLESONIDE) | Covis | Small molecule | 2028-02-01 | 4 patents | Method of Use |
| Topamax (topiramate) | Janssen | Small molecule | 2028-04-04 | 4 patents | Method of Use |
| Versed (midazolam) | Generic (originally Roche) | Small molecule | 2028-01-18 | 4 patents | Formulation Method of Use |
| cysteamine-bitartrate (CYSTEAMINE BITARTRATE) | — | Small molecule | 2028-03-22 | 4 patents | Other |
| azelastine-hydrochloride (AZELASTINE HYDROCHLORIDE) | — | Small molecule | 2028-06-04 | 4 patents | Formulation |
| Kyprolis (carfilzomib) | Amgen | Small molecule | 2028-06-07 | 3 patents | Other |
| Mayzent (SIPONIMOD) | Novartis | Small molecule | 2028-08-27 | 3 patents | Composition of Matter |
| Metro I.V. In Plastic Container (METRONIDAZOLE) | Baxter | Small molecule | 2028-02-02 | 3 patents | Formulation Method of Use |
| Zometa (ZOLEDRONIC ACID) | Novartis | Small molecule | 2028-02-05 | 3 patents | Formulation Other |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2028-11-13 | 3 patents | Method of Use |
| neratinib-maleate (NERATINIB MALEATE) | — | Small molecule | 2028-10-15 | 3 patents | Method of Use |
| Amaryl (GLIMEPIRIDE) | Sanofi | Small molecule | 2028-06-08 | 2 patents | Formulation |
| Angiomax (BIVALIRUDIN) | Novartis | Small molecule | 2028-07-27 | 2 patents | Formulation |
| Arnuity Ellipta (FLUTICASONE FUROATE) | Haleon Us Holdings | Small molecule | 2028-07-15 | 2 patents | Formulation |
| Bevyxxa (BETRIXABAN) | Portola Pharms Inc | Small molecule | 2028-09-08 | 2 patents | Method of Use |
| Brenzavvy (BEXAGLIFLOZIN) | Theracosbio | Small molecule | 2028-08-22 | 2 patents | Method of Use |
| Caprelsa (VANDETANIB) | Sanofi | Small molecule | 2028-08-08 | 2 patents | Formulation |
| Daurismo (Glasdegib Maleate) | Pfizer | Small molecule | 2028-06-29 | 2 patents | Formulation |
| Derma-Smoothe/Fs (FLUOCINOLONE ACETONIDE) | Eurofarma | Small molecule | 2028-01-12 | 2 patents | Method of Use |
| Erivedge (vismodegib) | Roche | Small molecule | 2028-11-11 | 2 patents | Composition of Matter Method of Use |
| Exondys 51 (ETEPLIRSEN) | Sarepta | Small molecule | 2028-10-27 | 2 patents | Method of Use |
| Keppra (levetiracetam) | Generic (originally UCB Pharma) | Small molecule | 2028-09-17 | 2 patents | Formulation |
| Myrbetriq (MIRABEGRON) | Apgdi | Small molecule | 2028-10-30 | 2 patents | Method of Use |
| Nourianz (ISTRADEFYLLINE) | Kyowa Kirin | Small molecule | 2028-01-28 | 2 patents | Method of Use |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2028-11-12 | 2 patents | Formulation Method of Use |
| Renacidin (CITRIC ACID) | Baxter | Small molecule | 2028-10-10 | 2 patents | Formulation |
| Spiriva (TIOTROPIUM BROMIDE) | Boehringer Ingelheim | Small molecule | 2028-03-13 | 2 patents | Formulation Other |
| Tecfidera (DIMETHYL FUMARATE) | Biogen | Small molecule | 2028-02-07 | 2 patents | Method of Use |
| Tegretol (carbamazepine) | Novartis AG (originally Geigy) | Small molecule | 2028-11-10 | 2 patents | Formulation Method of Use |
| Yondelis (TRABECTEDIN) | Janssen Prods | Small molecule | 2028-01-07 | 2 patents | Formulation Other |
| Zurampic (LESINURAD) | Ironwood Pharms Inc | Small molecule | 2028-11-26 | 2 patents | Method of Use |
| Zykadia (ceritinib) | Novartis | Small molecule | 2028-04-29 | 2 patents | Composition of Matter |
| olodaterol-hydrochloride (OLODATEROL HYDROCHLORIDE) | — | Small molecule | 2028-03-13 | 2 patents | Formulation Other |
| fostamatinib-disodium (FOSTAMATINIB DISODIUM) | — | Small molecule | 2028-11-06 | 2 patents | Formulation |
| isopropyl-alcohol (ISOPROPYL ALCOHOL) | — | Small molecule | 2028-05-23 | 2 patents | Formulation Method of Use |
| chembl-chembl1200775 (LEUPROLIDE ACETATE) | — | Small molecule | 2028-03-22 | 2 patents | Method of Use |
| lutetium-lu-177-vipivotide-tetraxetan (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) | — | Small molecule | 2028-08-15 | 2 patents | Method of Use |
| mesalamine (MESALAMINE) | — | Small molecule | 2028-06-06 | 2 patents | Formulation |
| metformin-hydrochloride (METFORMIN HYDROCHLORIDE) | — | Small molecule | 2028-07-21 | 2 patents | Method of Use |
| cedazuridine (CEDAZURIDINE) | — | Small molecule | 2028-10-16 | 2 patents | Composition of Matter Method of Use |
| pexidartinib-hydrochloride (PEXIDARTINIB HYDROCHLORIDE) | — | Small molecule | 2028-04-19 | 2 patents | Method of Use |
| prednisolone-acetate (PREDNISOLONE ACETATE) | — | Small molecule | 2028-10-11 | 2 patents | Method of Use |
| saxagliptin-hydrochloride (SAXAGLIPTIN HYDROCHLORIDE) | — | Small molecule | 2028-11-30 | 2 patents | Formulation |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2028-09-07 | 2 patents | Formulation |
| abacavir-sulfate (ABACAVIR SULFATE) | — | Small molecule | 2028-04-05 | 2 patents | Other |
| Addyi (FLIBANSERIN) | Sprout Pharms | Small molecule | 2028-05-09 | 1 patents | Method of Use |
| Arthrotec (Diclofenac Sodium) | Pfizer | Small molecule | 2028-04-21 | 1 patents | Method of Use |
| Camptosar (Irinotecan Hydrochloride) | Pfizer | Small molecule | 2028-08-29 | 1 patents | Composition of Matter |
| Clozaril (CLOZAPINE) | Jazz Pharmaceuticals | Small molecule | 2028-05-01 | 1 patents | Formulation |
| Cubicin (Daptomycin) | Baxter | Small molecule | 2028-09-04 | 1 patents | Method of Use |
| Cytarabine (Cytarabine) | Nippon Shinyaku Co., Ltd. | Small molecule | 2028-03-14 | 1 patents | Other |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2028-08-03 | 1 patents | Method of Use |
| Deltasone (prednisone) | Generic (originally Schering) | Small molecule | 2028-01-07 | 1 patents | Method of Use |
| Differin (ADAPALENE) | Galderma Labs Lp | Small molecule | 2028-05-31 | 1 patents | Method of Use |
| Dovonex (CALCIPOTRIENE) | — | Small molecule | 2028-05-07 | 1 patents | Method of Use |
| Inrebic (FEDRATINIB HYDROCHLORIDE) | Bristol-Myers Squibb | Small molecule | 2028-06-30 | 1 patents | Method of Use |
| Intrarosa (PRASTERONE) | — | Small molecule | 2028-08-07 | 1 patents | Formulation |
| Lynparza (olaparib) | AstraZeneca | Small molecule | 2028-09-24 | 1 patents | Composition of Matter |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2028-08-27 | 1 patents | Method of Use |
| Mitozytrex (MITOMYCIN) | Kyowa Kirin Co., Ltd. | Small molecule | 2028-01-02 | 1 patents | Method of Use |
| Moizerto (DIFAMILAST) | OTSUKA PHARMACEUTICAL Co., Ltd | Small molecule | 2028-03-01 | 1 patents | Method of Use |
| Mulpleta (LUSUTROMBOPAG) | Vancocin Italia | Small molecule | 2028-07-29 | 1 patents | Composition of Matter |
| Natazia (DIENOGEST) | Mochida Pharmaceutical Co., Ltd. | Small molecule | 2028-01-30 | 1 patents | Method of Use |
| Opsumit (MACITENTAN) | AstraZeneca | Small molecule | 2028-10-04 | 1 patents | Method of Use |
| Osphena (OSPEMIFENE) | Duchesnay | Small molecule | 2028-07-09 | 1 patents | Formulation |
| Qutenza (CAPSAICIN) | Averitas | Small molecule | 2028-12-15 | 1 patents | Formulation |
| Recorlev (LEVOKETOCONAZOLE) | Strongbridge | Small molecule | 2028-05-03 | 1 patents | Method of Use |
| Rydapt (MIDOSTAURIN) | Novartis | Small molecule | 2028-10-09 | 1 patents | Method of Use |
| Slynd (DROSPIRENONE) | Exeltis Usa Inc | Small molecule | 2028-01-15 | 1 patents | Method of Use |
| Sporanox (itraconazole) | Sebela Ireland Ltd | Small molecule | 2028-10-03 | 1 patents | Method of Use |
| Spy Agent Green Kit (INDOCYANINE GREEN) | Renew Pharms | Small molecule | 2028-06-04 | 1 patents | Method of Use |
| Suprax (CEFIXIME) | — | Small molecule | 2028-12-14 | 1 patents | Method of Use |
| Temovate (CLOBETASOL PROPIONATE) | Fougera Pharms | Small molecule | 2028-11-05 | 1 patents | Method of Use |
| Tobi (tobramycin) | Novartis | Small molecule | 2028-09-12 | 1 patents | Method of Use |
| Topicort (DESOXIMETASONE) | Taro | Small molecule | 2028-09-01 | 1 patents | Method of Use |
| Trulance (PLECANATIDE) | Salix | Small molecule | 2028-01-30 | 1 patents | Composition of Matter |
| Tygacil (TIGECYCLINE) | Fresenius Kabi | Small molecule | 2028-10-24 | 1 patents | Formulation |
| Vyondys 53 (GOLODIRSEN) | Sarepta | Small molecule | 2028-06-28 | 1 patents | Formulation |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2028-10-15 | 1 patents | Method of Use |
| Yupelri (REVEFENACIN) | Mylan Ireland Ltd | Small molecule | 2028-10-31 | 1 patents | Composition of Matter |
| Zolinza (VORINOSTAT) | Merck & Co. | Small molecule | 2028-03-18 | 1 patents | Method of Use |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2028-06-17 | 1 patents | Composition of Matter |
| telotristat-etiprate (TELOTRISTAT ETIPRATE) | — | Small molecule | 2028-12-19 | 1 patents | Method of Use |
| sodium-phosphate-dibasic-anhydrous (SODIUM PHOSPHATE, DIBASIC, ANHYDROUS) | — | Small molecule | 2028-06-22 | 1 patents | Composition of Matter |
| sorafenib-tosylate (SORAFENIB TOSYLATE) | — | Small molecule | 2028-09-10 | 1 patents | Method of Use |
| albuterol-sulfate (ALBUTEROL SULFATE) | — | Small molecule | 2028-03-13 | 1 patents | Formulation |
| AMJEVITA | AMGEN INC | Biologic | 2028-09-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ANTHIM (OBILTOXAXIMAB) | Elusys Therapeutics Inc | Biologic | 2028-03-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| CINQAIR (RESLIZUMAB) | Teva Respiratory Llc | Biologic | 2028-03-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| INFLECTRA (Infliximab-Dyyb) | Asan Medical Center | Biologic | 2028-04-05 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SOLIQUA 100/33 | SANOFI-AVENTIS US | Biologic | 2028-11-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TALTZ (ixekizumab) | Eli Lilly | Biologic | 2028-03-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Tecentriq (atezolizumab) | Roche | Biologic | 2028-05-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Tivdak (tisotumab-vedotin) | SEAGEN | Biologic | 2028-09-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| XULTOPHY 100/3.6 | NOVO | Biologic | 2028-11-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZINPLAVA (BEZLOTOXUMAB) | Merck & Co. | Biologic | 2028-10-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | GENENTECH INC | Biologic | 2028-10-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SANDOZ | Biologic | 2028-08-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SANOFI-AVENTIS US | Biologic | 2028-07-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BIOGEN | Biologic | 2028-05-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ELI LILLY AND CO | Biologic | 2028-10-19 | 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.