Patent Cliff Calendar

Drugs losing US patent exclusivity in 2027

164 drugs face loss of exclusivity in 2027 · 146 small-molecule via Orange Book · 18 biologic via Purple Book BPCIA

Sourced from FDA Orange Book + Purple Book · Updated 2026-05-17

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.

2027 is a near-term cliff (1 year away). Biosimilar / generic filers are preparing IPR petitions and 351(k) / ANDA filings now.

Drugs losing exclusivity in 2027

Drug Manufacturer Type Earliest expiry Patent estate Patent classifications
Kalydeco (IVACAFTOR) Vertex Pharms Inc Small molecule 2027-01-06 114 patents Composition of Matter Method of Use Other
Imbruvica (ibrutinib) AbbVie Small molecule 2027-04-26 87 patents Composition of Matter Method of Use Other
Duragesic (fentanyl) Johnson & Johnson (Janssen Pharmaceutica) Small molecule 2027-01-25 54 patents Formulation Method of Use
Jardiance (empagliflozin) Boehringer Ingelheim Small molecule 2027-04-15 44 patents Composition of Matter Formulation Method of Use Other
cysteamine-bitartrate (CYSTEAMINE BITARTRATE) Small molecule 2027-01-26 44 patents Method of Use Other
Topamax (topiramate) Janssen Small molecule 2027-11-16 36 patents Method of Use
chembl-chembl2103744 (MORPHINE SULFATE) Small molecule 2027-06-19 36 patents Formulation Method of Use
oxcarbazepine (OXCARBAZEPINE) Small molecule 2027-04-13 33 patents Formulation Method of Use
Farxiga (DAPAGLIFLOZIN) AstraZeneca Small molecule 2027-02-18 30 patents Method of Use Other
Subutex (Buprenorphine Hydrochloride) Indivior Small molecule 2027-07-23 26 patents Method of Use
nicardipine-hydrochloride (NICARDIPINE HYDROCHLORIDE) Small molecule 2027-04-18 22 patents Formulation Method of Use
Abilify (aripiprazole) Generic (originally Otsuka/BMS) Small molecule 2027-03-02 21 patents Method of Use
Injectafer (FERRIC CARBOXYMALTOSE) Am Regent Small molecule 2027-01-08 20 patents Composition of Matter Method of Use
Invokana (CANAGLIFLOZIN) Johnson & Johnson Small molecule 2027-07-14 20 patents Composition of Matter Method of Use
Tradjenta (LINAGLIPTIN) Boehringer Ingelheim Small molecule 2027-05-04 19 patents Formulation Method of Use Other
minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) Small molecule 2027-03-07 19 patents Formulation Method of Use
doxepin-hydrochloride (DOXEPIN HYDROCHLORIDE) Small molecule 2027-05-18 18 patents Method of Use
Jesduvroq (DAPRODUSTAT) GSK Small molecule 2027-06-22 15 patents Method of Use
Risperdal (risperidone) Johnson & Johnson (Janssen) Small molecule 2027-11-12 14 patents Method of Use
oxymorphone-hydrochloride (OXYMORPHONE HYDROCHLORIDE) Small molecule 2027-06-21 14 patents Method of Use
sufentanil-citrate (SUFENTANIL CITRATE) Small molecule 2027-01-05 13 patents Formulation Method of Use
Arthrotec (Diclofenac Sodium) Pfizer Small molecule 2027-03-22 12 patents Formulation Method of Use
Palbociclib (palbociclib) Pfizer Inc. Small molecule 2027-03-05 12 patents Composition of Matter Other
Toviaz (Fesoterodine Fumarate) Pfizer Small molecule 2027-06-07 12 patents Formulation Method of Use Other
difelikefalin-acetate (DIFELIKEFALIN ACETATE) Small molecule 2027-11-12 12 patents Method of Use
vadadustat (VADADUSTAT) Small molecule 2027-06-26 12 patents Composition of Matter Method of Use
nilotinib-hydrochloride (Nilotinib Hydrochloride) Jan Beumer Small molecule 2027-01-18 12 patents Formulation Other
Dificid (FIDAXOMICIN) Cubist Pharms Llc Small molecule 2027-03-04 10 patents Composition of Matter Formulation Method of Use Other
Lyrica (Pregabalin) Pfizer Inc. Small molecule 2027-05-02 9 patents Other
Uptravi (SELEXIPAG) AstraZeneca Small molecule 2027-04-30 9 patents Other
Arnuity Ellipta (FLUTICASONE FUROATE) Haleon Us Holdings Small molecule 2027-06-14 8 patents Composition of Matter Method of Use Other
Ozempic (semaglutide) Novo Nordisk Small molecule 2027-02-27 8 patents Formulation
Tybost (COBICISTAT) Gilead Sciences Small molecule 2027-02-27 8 patents Other
Fanapt (ILOPERIDONE) Vanda Pharms Inc Small molecule 2027-11-02 7 patents Method of Use
Lynparza (olaparib) AstraZeneca Small molecule 2027-08-12 7 patents Composition of Matter Method of Use
Prezista (DARUNAVIR) Janssen Prods Small molecule 2027-06-26 7 patents Other
Subutex (BUPRENORPHINE) Purdue Pharma Lp Small molecule 2027-01-10 7 patents Method of Use
metformin-hydrochloride (METFORMIN HYDROCHLORIDE) Small molecule 2027-01-22 7 patents Formulation Other
lomitapide-mesylate (LOMITAPIDE MESYLATE) Small molecule 2027-08-19 7 patents Method of Use
Amitiza (LUBIPROSTONE) Sucampo Pharma Llc Small molecule 2027-01-23 6 patents Formulation
Erleada (apalutamide) Johnson & Johnson Small molecule 2027-03-27 6 patents Composition of Matter Formulation Method of Use
Keppra (levetiracetam) Generic (originally UCB Pharma) Small molecule 2027-09-03 6 patents Formulation
Kyprolis (carfilzomib) Amgen Small molecule 2027-01-20 6 patents Formulation Other
Neupro (ROTIGOTINE) UCB Small molecule 2027-09-01 6 patents Method of Use
Remodulin (TREPROSTINIL) United Therap Small molecule 2027-05-14 6 patents Method of Use
Revlimid (lenalidomide) Bristol-Myers Squibb Small molecule 2027-04-27 6 patents Composition of Matter
Vitekta (ELVITEGRAVIR) Gilead Sciences Small molecule 2027-02-27 6 patents Other
naloxone-hydrochloride (Naloxone Hydrochloride) Pfizer Inc. Small molecule 2027-02-20 6 patents Formulation Method of Use
pexidartinib-hydrochloride (PEXIDARTINIB HYDROCHLORIDE) Small molecule 2027-11-21 6 patents Composition of Matter
Aveed (TESTOSTERONE UNDECANOATE) Marius Small molecule 2027-01-06 5 patents Formulation Method of Use
Cytarabine (Cytarabine) Nippon Shinyaku Co., Ltd. Small molecule 2027-01-23 5 patents Formulation Method of Use Other
Opsumit (MACITENTAN) AstraZeneca Small molecule 2027-03-11 5 patents Method of Use Other
Xalkori (crizotinib) Pfizer Small molecule 2027-05-12 5 patents Method of Use
fentanyl-citrate (FENTANYL CITRATE) Small molecule 2027-07-23 5 patents Method of Use
bosutinib-monohydrate (BOSUTINIB MONOHYDRATE) Small molecule 2027-05-23 5 patents Other
Androgel (TESTOSTERONE) Besins Hlthcare Small molecule 2027-02-26 4 patents Method of Use
Dexilant (DEXLANSOPRAZOLE) Takeda Small molecule 2027-02-02 4 patents Other
Eliquis (apixaban) Bristol-Myers Squibb Small molecule 2027-05-21 4 patents Other
Emend (APREPITANT) Merck & Co. Small molecule 2027-09-26 4 patents Method of Use
Eucrisa (Crisaborole) Anacor Pharms Inc Small molecule 2027-02-16 4 patents Method of Use Other
Letairis (AMBRISENTAN) Gilead Sciences Small molecule 2027-12-11 4 patents Method of Use
Vascepa (ICOSAPENT ETHYL) Amarin Pharms Small molecule 2027-05-31 4 patents Method of Use
Zykadia (ceritinib) Novartis Small molecule 2027-11-20 4 patents Composition of Matter Method of Use
olodaterol-hydrochloride (OLODATEROL HYDROCHLORIDE) Small molecule 2027-01-19 4 patents Composition of Matter Formulation Other
capmatinib-hydrochloride (CAPMATINIB HYDROCHLORIDE) Small molecule 2027-11-19 4 patents Composition of Matter Method of Use
ponatinib-hydrochloride (PONATINIB HYDROCHLORIDE) Small molecule 2027-01-24 4 patents Composition of Matter
umeclidinium-bromide (UMECLIDINIUM BROMIDE) Small molecule 2027-06-14 4 patents Composition of Matter Method of Use Other
chlorhexidine-gluconate (CHLORHEXIDINE GLUCONATE) Small molecule 2027-04-25 4 patents Method of Use
Azelex (AZELAIC ACID) Leo Pharma As Small molecule 2027-09-18 3 patents Formulation Method of Use
Deltasone (prednisone) Generic (originally Schering) Small molecule 2027-08-03 3 patents Method of Use
Differin (ADAPALENE) Galderma Labs Lp Small molecule 2027-07-18 3 patents Method of Use
Epipen (epinephrine) Pfizer Inc. Small molecule 2027-02-27 3 patents Formulation
Linzess (LINACLOTIDE) AbbVie Small molecule 2027-02-28 3 patents Other
Pristiq (Desvenlafaxine Succinate) Pfizer Small molecule 2027-07-05 3 patents Composition of Matter
Rayaldee (CALCIFEDIOL) Small molecule 2027-02-02 3 patents Formulation Method of Use
Spiriva (TIOTROPIUM BROMIDE) Boehringer Ingelheim Small molecule 2027-03-31 3 patents Formulation Other
Xtandi (enzalutamide) Astellas Pharma Small molecule 2027-08-13 3 patents Composition of Matter
sitagliptin-phosphate (SITAGLIPTIN PHOSPHATE) Small molecule 2027-05-24 3 patents Other
afatinib-dimaleate (AFATINIB DIMALEATE) Small molecule 2027-05-09 3 patents Other
Amaryl (GLIMEPIRIDE) Sanofi Small molecule 2027-01-30 2 patents Formulation
Argatroban (ARGATROBAN) Hikma Pharm Co Ltd Small molecule 2027-09-26 2 patents Method of Use
Aubagio (TERIFLUNOMIDE) Sanofi Small molecule 2027-03-12 2 patents Other
Catapres-Tts-1 (CLONIDINE) Lavipharm Small molecule 2027-04-17 2 patents Formulation
Decadron (dexamethasone) Generic (originally Merck) Small molecule 2027-12-19 2 patents Formulation Method of Use
Derma-Smoothe/Fs (FLUOCINOLONE ACETONIDE) Eurofarma Small molecule 2027-08-12 2 patents Formulation
Jadelle (LEVONORGESTREL) Fdn Consumer Small molecule 2027-02-07 2 patents Formulation
Kybella (DEOXYCHOLIC ACID) AbbVie Small molecule 2027-12-10 2 patents Method of Use
Lastacaft (ALCAFTADINE) AbbVie Small molecule 2027-03-19 2 patents Method of Use
Lumigan (BIMATOPROST) Small molecule 2027-04-07 2 patents Composition of Matter Method of Use
Nexplanon (ETONOGESTREL) Small molecule 2027-05-31 2 patents Formulation
Nourianz (ISTRADEFYLLINE) Kyowa Kirin Small molecule 2027-09-05 2 patents Formulation
Ocaliva (OBETICHOLIC ACID) Intercept Pharms Inc Small molecule 2027-02-21 2 patents Composition of Matter
Phoslo (CALCIUM ACETATE) Fresenius Medcl Care Small molecule 2027-07-20 2 patents Method of Use
Picato (INGENOL MEBUTATE) Leo Labs Small molecule 2027-07-06 2 patents Formulation
Steglatro (ERTUGLIFLOZIN) Merck & Co. Small molecule 2027-05-24 2 patents Other
Travatan (TRAVOPROST) Small molecule 2027-09-20 2 patents Formulation
Tukysa (tucatinib) Seagen Small molecule 2027-05-09 2 patents Method of Use
Tymlos (ABALOPARATIDE) Radius Small molecule 2027-10-03 2 patents Formulation Method of Use
Vibativ (TELAVANCIN HYDROCHLORIDE) Cumberland Small molecule 2027-01-01 2 patents Composition of Matter
Victrelis (BOCEPREVIR) Merck & Co. Small molecule 2027-03-17 2 patents Method of Use
Vocabria (CABOTEGRAVIR) GSK Small molecule 2027-06-30 2 patents Method of Use
Xifaxan (rifaximin) Bausch Health Small molecule 2027-09-02 2 patents Composition of Matter Method of Use
Zocor (simvastatin) Merck & Co. Small molecule 2027-04-26 2 patents Formulation
Zovirax (ACYCLOVIR) Ligand Pharms Small molecule 2027-03-23 2 patents Method of Use
telotristat-etiprate (TELOTRISTAT ETIPRATE) Small molecule 2027-12-11 2 patents Composition of Matter Method of Use
abacavir-sulfate (ABACAVIR SULFATE) Small molecule 2027-10-05 2 patents Composition of Matter
ivabradine-hydrochloride (IVABRADINE HYDROCHLORIDE) Small molecule 2027-06-12 2 patents Other
regadenoson (Regadenoson) Pfizer Inc. Small molecule 2027-02-02 2 patents Composition of Matter Formulation
avacincaptad-pegol-sodium (AVACINCAPTAD PEGOL SODIUM) Small molecule 2027-02-14 2 patents Composition of Matter Method of Use
Altabax (RETAPAMULIN) Almirall Small molecule 2027-02-14 1 patents Composition of Matter
Amoxil (amoxicillin) Generic (originally Beecham/GSK) Small molecule 2027-05-07 1 patents Method of Use
Antizol (FOMEPIZOLE) Par Pharm Inc Small molecule 2027-06-30 1 patents Composition of Matter
Asclera (POLIDOCANOL) Provensis Small molecule 2027-11-19 1 patents Method of Use
Beleodaq (belinostat) Acrotech Biopharma Small molecule 2027-10-27 1 patents Formulation
Camptosar (Irinotecan Hydrochloride) Pfizer Small molecule 2027-01-06 1 patents Composition of Matter
Diprolene (BETAMETHASONE DIPROPIONATE) Merck & Co. Small molecule 2027-09-27 1 patents Formulation
Duavee (Bazedoxifene Acetate) Pfizer Inc. Small molecule 2027-03-10 1 patents Method of Use
Ecclock (SOFPIRONIUM BROMIDE) Kaken Pharmaceutical Small molecule 2027-03-26 1 patents Composition of Matter
Elocon (MOMETASONE FUROATE) Merck & Co. Small molecule 2027-06-12 1 patents Method of Use
Inomax (NITRIC OXIDE) Vero Biotech Inc Small molecule 2027-04-21 1 patents Formulation
Klisyri (TIRBANIBULIN) Almirall Small molecule 2027-12-28 1 patents Formulation
Mektovi (binimetinib) Pfizer Small molecule 2027-03-13 1 patents Composition of Matter
Nevanac (NEPAFENAC) Harrow Health Small molecule 2027-01-31 1 patents Method of Use
Onpattro (PATISIRAN SODIUM) Alnylam Pharmaceuticals Small molecule 2027-10-03 1 patents Formulation
Ovide (MALATHION) Taro Small molecule 2027-02-01 1 patents Method of Use
Sandimmune (cyclosporine) Novartis AG (originally Sandoz) Small molecule 2027-11-03 1 patents Formulation
Tracleer (BOSENTAN) AstraZeneca Small molecule 2027-12-28 1 patents Formulation
Triferic (FERRIC PYROPHOSPHATE CITRATE) Rockwell Medical Inc Small molecule 2027-09-08 1 patents Method of Use
Tussionex Pennkinetic (CHLORPHENIRAMINE MALEATE) Bayer Small molecule 2027-02-28 1 patents Formulation
Verdeso (DESONIDE) Padagis Us Small molecule 2027-08-13 1 patents Method of Use
Vibramycin (doxycycline) Generic (originally Pfizer) Small molecule 2027-12-19 1 patents Method of Use
Winlevi (CLASCOTERONE) Sun Pharma Small molecule 2027-01-12 1 patents Method of Use
Zolinza (VORINOSTAT) Merck & Co. Small molecule 2027-03-11 1 patents Composition of Matter
esketamine-hydrochloride (ESKETAMINE HYDROCHLORIDE) Small molecule 2027-03-20 1 patents Method of Use
sorafenib-tosylate (SORAFENIB TOSYLATE) Small molecule 2027-12-24 1 patents Method of Use
macimorelin-acetate (MACIMORELIN ACETATE) Small molecule 2027-10-12 1 patents Method of Use
mesalamine (MESALAMINE) Small molecule 2027-07-24 1 patents Composition of Matter
fingolimod-hydrochloride (FINGOLIMOD HYDROCHLORIDE) Small molecule 2027-12-25 1 patents Method of Use
chembl-chembl428647 (PACLITAXEL) Small molecule 2027-02-13 1 patents Other
chembl-chembl1200962 (CEFEPIME HYDROCHLORIDE) Small molecule 2027-12-03 1 patents Method of Use
chembl-chembl112 (ACETAMINOPHEN) Small molecule 2027-06-01 1 patents Method of Use
fostemsavir-tromethamine (FOSTEMSAVIR TROMETHAMINE) Small molecule 2027-11-19 1 patents Composition of Matter
nusinersen-sodium (NUSINERSEN SODIUM) Small molecule 2027-07-11 1 patents Composition of Matter
uridine-triacetate (URIDINE TRIACETATE) Small molecule 2027-08-17 1 patents Method of Use
albuterol-sulfate (ALBUTEROL SULFATE) Small molecule 2027-03-31 1 patents Formulation
givinostat-hydrochloride (GIVINOSTAT HYDROCHLORIDE) Small molecule 2027-01-15 1 patents Composition of Matter
BASAGLAR KWIKPEN (INSULIN GLARGINE) Sanofi Biologic 2027-12-16 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
COSENTYX (secukinumab) Novartis Biologic 2027-01-21 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
DARZALEX (daratumumab) Johnson & Johnson Biologic 2027-11-16 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
EMPLICITI (elotuzumab) Bristol-Myers Squibb Biologic 2027-11-30 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
HUMALOG KWIKPEN (INSULIN LISPRO) Eli Lilly Biologic 2027-05-26 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
KANUMA ALEXION PHARM Biologic 2027-12-08 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
NUCALA (MEPOLIZUMAB) GSK Biologic 2027-11-04 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
PORTRAZZA (NECITUMUMAB) Eli Lilly Co Biologic 2027-11-24 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
PRALUENT (ALIROCUMAB) Sanofi Biologic 2027-07-24 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
PRAXBIND (IDARUCIZUMAB) Boehringer Ingelheim Biologic 2027-10-16 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
STRENSIQ (ASFOTASE ALFA) AstraZeneca Biologic 2027-10-23 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
TOUJEO (INSULIN GLARGINE) Sanofi Biologic 2027-02-25 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
TRESIBA (INSULIN DEGLUDEC) Novo Nordisk Biologic 2027-09-25 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
UNITUXIN (DINUTUXIMAB) United Therap Biologic 2027-03-10 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
ZARXIO (Filgrastim-sndz) M.D. Anderson Cancer Center Biologic 2027-03-06 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
(unknown) NPS PHARMS INC Biologic 2027-01-23 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
(unknown) BRISTOL MYERS SQUIBB Biologic 2027-03-04 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity
(unknown) NOVO Biologic 2027-09-25 BPCIA 12-yr exclusivity BPCIA Biologic Exclusivity

Sources

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.