Patent Cliff Calendar
Drugs losing US patent exclusivity in 2030
174 drugs face loss of exclusivity in 2030 · 150 small-molecule via Orange Book · 24 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.
2030 is a mid-term cliff (4 years away). Lifecycle moves — subcutaneous formulations, label extensions, combination filings — typically execute 18-36 months ahead of expiry.
Drugs losing exclusivity in 2030
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Vascepa (ICOSAPENT ETHYL) | Amarin Pharms | Small molecule | 2030-02-09 | 72 patents | Formulation Method of Use |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2030-01-02 | 58 patents | Composition of Matter Formulation Method of Use Other |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2030-02-11 | 52 patents | Formulation Method of Use Other |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2030-03-29 | 48 patents | Formulation Method of Use |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2030-03-19 | 48 patents | Formulation Method of Use |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2030-01-18 | 40 patents | Formulation Method of Use Other |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2030-02-12 | 36 patents | Composition of Matter Method of Use Other |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2030-04-12 | 34 patents | Composition of Matter Formulation Method of Use |
| Fanapt (ILOPERIDONE) | Vanda Pharms Inc | Small molecule | 2030-04-05 | 28 patents | Method of Use |
| milsaperidone (Milsaperidone) | Vanda Pharmaceuticals | Small molecule | 2030-04-05 | 28 patents | Method of Use |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2030-02-05 | 26 patents | Formulation Method of Use Other |
| Arnuity Ellipta (FLUTICASONE FUROATE) | Haleon Us Holdings | Small molecule | 2030-03-08 | 20 patents | Formulation Method of Use Other |
| Steglatro (ERTUGLIFLOZIN) | Merck & Co. | Small molecule | 2030-07-13 | 20 patents | Formulation Method of Use |
| cabozantinib-s-malate (CABOZANTINIB S-MALATE) | — | Small molecule | 2030-01-15 | 20 patents | Composition of Matter Formulation Method of Use |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2030-10-01 | 19 patents | Formulation Method of Use |
| chembl-chembl43452 (POMALIDOMIDE) | — | Small molecule | 2030-05-19 | 16 patents | Formulation Other |
| Aristada (ARIPIPRAZOLE LAUROXIL) | Alkermes Inc | Small molecule | 2030-06-24 | 15 patents | Composition of Matter Method of Use |
| OxyContin (oxycodone) | Purdue Pharma | Small molecule | 2030-12-10 | 15 patents | Method of Use |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2030-04-19 | 15 patents | Composition of Matter Formulation Method of Use |
| Duragesic (fentanyl) | Johnson & Johnson (Janssen Pharmaceutica) | Small molecule | 2030-04-27 | 14 patents | Formulation Method of Use |
| Ravicti (GLYCEROL PHENYLBUTYRATE) | Horizon Therap Us | Small molecule | 2030-09-22 | 14 patents | Method of Use |
| Voltaren (DICLOFENAC) | Hisamitsu Pharmaceutical Co., Inc | Small molecule | 2030-04-23 | 14 patents | Formulation Method of Use |
| Braftovi (encorafenib) | Pfizer | Small molecule | 2030-02-26 | 13 patents | Composition of Matter Formulation Method of Use |
| Neupro (ROTIGOTINE) | UCB | Small molecule | 2030-12-22 | 12 patents | Formulation |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2030-06-10 | 10 patents | Method of Use Other |
| Subutex (Buprenorphine Hydrochloride) | Indivior | Small molecule | 2030-03-26 | 10 patents | Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2030-03-03 | 10 patents | Method of Use Other |
| Parsabiv (ETELCALCETIDE) | Kai Pharms Inc | Small molecule | 2030-07-29 | 9 patents | Composition of Matter Method of Use |
| afatinib-dimaleate (AFATINIB DIMALEATE) | — | Small molecule | 2030-04-10 | 9 patents | Formulation Other |
| cetirizine-hydrochloride (CETIRIZINE HYDROCHLORIDE) | — | Small molecule | 2030-02-11 | 9 patents | Formulation Method of Use Other |
| Myrbetriq (MIRABEGRON) | Apgdi | Small molecule | 2030-03-28 | 8 patents | Other |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2030-05-28 | 8 patents | Method of Use |
| Samsca (TOLVAPTAN) | Otsuka | Small molecule | 2030-04-07 | 8 patents | Formulation |
| Akynzeo (NETUPITANT) | Helsinn Hlthcare | Small molecule | 2030-11-18 | 7 patents | Formulation Method of Use |
| Alphagan (BRIMONIDINE TARTRATE) | Senju Pharmaceutical Co., Ltd | Small molecule | 2030-05-24 | 7 patents | Formulation Method of Use |
| Diprolene (BETAMETHASONE DIPROPIONATE) | Merck & Co. | Small molecule | 2030-08-31 | 7 patents | Method of Use |
| Sodium Nitrite (SODIUM NITRITE) | Hope Pharms | Small molecule | 2030-02-10 | 7 patents | Composition of Matter Formulation Method of Use |
| Celebrex (celecoxib) | Pfizer Inc. (originally Searle/Pharmacia) | Small molecule | 2030-04-19 | 6 patents | Composition of Matter Method of Use |
| Indocin Sr (INDOMETHACIN) | — | Small molecule | 2030-04-23 | 6 patents | Formulation Method of Use |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2030-06-14 | 6 patents | Formulation |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2030-04-29 | 6 patents | Composition of Matter Other |
| vosoritide (VOSORITIDE) | — | Small molecule | 2030-05-20 | 6 patents | Method of Use |
| sufentanil-citrate (SUFENTANIL CITRATE) | — | Small molecule | 2030-03-16 | 6 patents | Formulation Method of Use |
| Briviact (BRIVARACETAM) | UCB | Small molecule | 2030-04-09 | 5 patents | Formulation |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2030-07-04 | 5 patents | Composition of Matter |
| Imitrex (SUMATRIPTAN) | GSK | Small molecule | 2030-06-16 | 5 patents | Formulation Method of Use |
| Jublia (EFINACONAZOLE) | Bausch Health | Small molecule | 2030-07-08 | 5 patents | Formulation Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2030-05-26 | 5 patents | Formulation Method of Use |
| Remodulin (TREPROSTINIL) | United Therap | Small molecule | 2030-06-11 | 5 patents | Formulation |
| Sodium Thiosulfate (SODIUM THIOSULFATE) | Us Army | Small molecule | 2030-02-10 | 5 patents | Composition of Matter Formulation Method of Use |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2030-01-27 | 5 patents | Method of Use |
| Yupelri (REVEFENACIN) | Mylan Ireland Ltd | Small molecule | 2030-07-14 | 5 patents | Composition of Matter Formulation Method of Use |
| Amondys 45 (CASIMERSEN) | Sarepta | Small molecule | 2030-11-12 | 4 patents | Composition of Matter Method of Use |
| Amoxil (amoxicillin) | Generic (originally Beecham/GSK) | Small molecule | 2030-04-10 | 4 patents | Composition of Matter Formulation |
| Aptiom (ESLICARBAZEPINE ACETATE) | Sumitomo Pharma Am | Small molecule | 2030-04-17 | 4 patents | Formulation |
| Brilinta (ticagrelor) | AstraZeneca | Small molecule | 2030-04-17 | 4 patents | Formulation Other |
| Dexilant (DEXLANSOPRAZOLE) | Takeda | Small molecule | 2030-03-17 | 4 patents | Method of Use Other |
| Invokana (CANAGLIFLOZIN) | Johnson & Johnson | Small molecule | 2030-07-06 | 4 patents | Formulation |
| Itovebi (INAVOLISIB) | Genentech Inc | Small molecule | 2030-09-27 | 4 patents | Composition of Matter Method of Use |
| Jevtana Kit (cabazitaxel) | Accord Hlthcare | Small molecule | 2030-10-27 | 4 patents | Method of Use |
| Kybella (DEOXYCHOLIC ACID) | AbbVie | Small molecule | 2030-03-02 | 4 patents | Formulation |
| Slynd (DROSPIRENONE) | Exeltis Usa Inc | Small molecule | 2030-02-08 | 4 patents | Formulation Method of Use |
| Temovate (CLOBETASOL PROPIONATE) | Fougera Pharms | Small molecule | 2030-08-31 | 4 patents | Method of Use |
| fosnetupitant-chloride-hydrochloride (FOSNETUPITANT CHLORIDE HYDROCHLORIDE) | — | Small molecule | 2030-11-18 | 4 patents | Method of Use |
| neratinib-maleate (NERATINIB MALEATE) | — | Small molecule | 2030-03-24 | 4 patents | Composition of Matter Method of Use |
| lanthanum-carbonate (LANTHANUM CARBONATE) | — | Small molecule | 2030-12-01 | 4 patents | Formulation |
| bromocriptine-mesylate (BROMOCRIPTINE MESYLATE) | — | Small molecule | 2030-06-07 | 4 patents | Method of Use |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2030-03-23 | 4 patents | Formulation Other |
| Aldara (IMIQUIMOD) | Bausch Health | Small molecule | 2030-04-30 | 3 patents | Method of Use |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2030-12-30 | 3 patents | Formulation Method of Use |
| Kyprolis (carfilzomib) | Amgen | Small molecule | 2030-04-21 | 3 patents | Other |
| Mayzent (SIPONIMOD) | Novartis | Small molecule | 2030-11-30 | 3 patents | Method of Use |
| Nubeqa (darolutamide) | Bayer | Small molecule | 2030-10-27 | 3 patents | Composition of Matter Method of Use |
| Travatan (TRAVOPROST) | — | Small molecule | 2030-06-18 | 3 patents | Formulation Method of Use |
| Venclexta (venetoclax) | AbbVie | Small molecule | 2030-05-26 | 3 patents | Method of Use |
| Xiidra (LIFITEGRAST) | Bausch Health | Small molecule | 2030-10-21 | 3 patents | Composition of Matter Formulation |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2030-03-19 | 3 patents | Formulation |
| nusinersen-sodium (NUSINERSEN SODIUM) | — | Small molecule | 2030-06-17 | 3 patents | Composition of Matter Method of Use |
| umeclidinium-bromide (UMECLIDINIUM BROMIDE) | — | Small molecule | 2030-11-29 | 3 patents | Formulation Method of Use |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2030-05-28 | 3 patents | Formulation Method of Use |
| Advil (ibuprofen) | Generic (originally Boots Group) | Small molecule | 2030-09-14 | 2 patents | Method of Use |
| Arthrotec (Diclofenac Sodium) | Pfizer | Small molecule | 2030-08-09 | 2 patents | Method of Use |
| Aubagio (TERIFLUNOMIDE) | Sanofi | Small molecule | 2030-09-14 | 2 patents | Formulation |
| Auryxia (FERRIC CITRATE) | Keryx Biopharms | Small molecule | 2030-07-21 | 2 patents | Formulation Method of Use |
| Bevyxxa (BETRIXABAN) | Portola Pharms Inc | Small molecule | 2030-12-28 | 2 patents | Formulation |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2030-02-12 | 2 patents | Formulation Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2030-09-15 | 2 patents | Method of Use |
| Eucrisa (Crisaborole) | Anacor Pharms Inc | Small molecule | 2030-01-20 | 2 patents | Method of Use Other |
| Gemzar (Gemcitabine Hydrochloride) | Accord Hlthcare | Small molecule | 2030-06-28 | 2 patents | Formulation |
| Inlyta (Axitinib) | Pfizer | Small molecule | 2030-12-14 | 2 patents | Composition of Matter |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2030-06-21 | 2 patents | Formulation |
| Inpefa (SOTAGLIFLOZIN) | Lexicon Pharms Inc | Small molecule | 2030-10-07 | 2 patents | Composition of Matter |
| Mektovi (binimetinib) | Pfizer | Small molecule | 2030-08-27 | 2 patents | Method of Use |
| Nexletol (BEMPEDOIC ACID) | Esperion Theraps Inc | Small molecule | 2030-12-03 | 2 patents | Composition of Matter |
| Nexplanon (ETONOGESTREL) | — | Small molecule | 2030-07-28 | 2 patents | Method of Use |
| Nuzyra (OMADACYCLINE TOSYLATE) | Paratek Pharms | Small molecule | 2030-09-23 | 2 patents | Composition of Matter Method of Use |
| Onpattro (PATISIRAN SODIUM) | Alnylam Pharmaceuticals | Small molecule | 2030-10-21 | 2 patents | Method of Use |
| Renvela (SEVELAMER CARBONATE) | Sanofi | Small molecule | 2030-12-06 | 2 patents | Formulation |
| Teflaro (CEFTAROLINE FOSAMIL) | AbbVie | Small molecule | 2030-09-21 | 2 patents | Formulation |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2030-03-06 | 2 patents | Other |
| Vidaza (azacitidine) | Bristol-Myers Squibb | Small molecule | 2030-06-03 | 2 patents | Method of Use |
| Xerava (ERAVACYCLINE DIHYDROCHLORIDE) | Tetraphase Pharms | Small molecule | 2030-12-28 | 2 patents | Formulation |
| Xtoro (FINAFLOXACIN) | Fonseca Biosciences | Small molecule | 2030-07-02 | 2 patents | Formulation Method of Use |
| Zocor (simvastatin) | Merck & Co. | Small molecule | 2030-02-23 | 2 patents | Formulation |
| Zofran (ondansetron) | GSK (originally Glaxo) | Small molecule | 2030-07-13 | 2 patents | Formulation |
| Zykadia (ceritinib) | Novartis | Small molecule | 2030-06-29 | 2 patents | Composition of Matter |
| abacavir-sulfate (ABACAVIR SULFATE) | — | Small molecule | 2030-06-08 | 2 patents | Other |
| fostamatinib-disodium (FOSTAMATINIB DISODIUM) | — | Small molecule | 2030-11-24 | 2 patents | Formulation |
| fexofenadine-hydrochloride (FEXOFENADINE HYDROCHLORIDE) | — | Small molecule | 2030-08-02 | 2 patents | Formulation |
| ferric-oxyhydroxide (FERRIC OXYHYDROXIDE) | — | Small molecule | 2030-01-23 | 2 patents | Method of Use Other |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2030-08-20 | 2 patents | Formulation Method of Use |
| doxepin-hydrochloride (DOXEPIN HYDROCHLORIDE) | — | Small molecule | 2030-09-07 | 2 patents | Method of Use |
| albuterol-sulfate (ALBUTEROL SULFATE) | — | Small molecule | 2030-05-28 | 2 patents | Formulation Method of Use |
| sparsentan (SPARSENTAN) | — | Small molecule | 2030-03-29 | 2 patents | Method of Use |
| Brexafemme (IBREXAFUNGERP CITRATE) | GSK | Small molecule | 2030-08-28 | 1 patents | Method of Use |
| Cipro (Ciprofloxacin) | Alk Abello | Small molecule | 2030-04-27 | 1 patents | Method of Use |
| Cubicin (Daptomycin) | Baxter | Small molecule | 2030-11-23 | 1 patents | Formulation |
| Endometrin (progesterone) | Ferring | Small molecule | 2030-01-21 | 1 patents | Method of Use |
| Entereg (ALVIMOPAN) | Cubist Pharms | Small molecule | 2030-02-12 | 1 patents | Method of Use |
| Exem Foam Kit (AIR POLYMER-TYPE A) | Giskit | Small molecule | 2030-10-15 | 1 patents | Method of Use |
| Intrarosa (PRASTERONE) | — | Small molecule | 2030-01-08 | 1 patents | Method of Use |
| Kengreal (CANGRELOR) | Chiesi | Small molecule | 2030-11-10 | 1 patents | Method of Use |
| Klisyri (TIRBANIBULIN) | Almirall | Small molecule | 2030-12-28 | 1 patents | Composition of Matter |
| Mulpleta (LUSUTROMBOPAG) | Vancocin Italia | Small molecule | 2030-01-21 | 1 patents | Composition of Matter |
| Nevanac (NEPAFENAC) | Harrow Health | Small molecule | 2030-12-01 | 1 patents | Formulation |
| Phoslo (CALCIUM ACETATE) | Fresenius Medcl Care | Small molecule | 2030-02-23 | 1 patents | Method of Use |
| Qutenza (CAPSAICIN) | Averitas | Small molecule | 2030-03-26 | 1 patents | Formulation |
| Rapamune (sirolimus) | Pfizer | Small molecule | 2030-04-15 | 1 patents | Formulation |
| Rayaldee (CALCIFEDIOL) | — | Small molecule | 2030-09-07 | 1 patents | Method of Use |
| Reglan (Metoclopramide Hydrochloride) | Hikma | Small molecule | 2030-05-16 | 1 patents | Method of Use |
| Rydapt (MIDOSTAURIN) | Novartis | Small molecule | 2030-12-02 | 1 patents | Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2030-12-13 | 1 patents | Formulation |
| Spiriva (TIOTROPIUM BROMIDE) | Boehringer Ingelheim | Small molecule | 2030-10-16 | 1 patents | Formulation |
| Tibsovo (IVOSIDENIB) | Servier | Small molecule | 2030-06-21 | 1 patents | Method of Use |
| Tobi (tobramycin) | Novartis | Small molecule | 2030-11-04 | 1 patents | Method of Use |
| Tygacil (TIGECYCLINE) | Fresenius Kabi | Small molecule | 2030-10-08 | 1 patents | Formulation |
| Velsipity (Etrasimod Arginine) | Pfizer Inc. | Small molecule | 2030-03-05 | 1 patents | Composition of Matter |
| Winlevi (CLASCOTERONE) | Sun Pharma | Small molecule | 2030-07-25 | 1 patents | Formulation |
| Xdemvy (LOTILANER) | Tarsus | Small molecule | 2030-01-17 | 1 patents | Composition of Matter |
| Zelboraf (vemurafenib) | Hoffmann La Roche | Small molecule | 2030-07-27 | 1 patents | Composition of Matter |
| Zovirax (ACYCLOVIR) | Ligand Pharms | Small molecule | 2030-06-16 | 1 patents | Method of Use |
| zoliflodacin (ZOLIFLODACIN) | — | Small molecule | 2030-06-20 | 1 patents | Composition of Matter |
| mesalamine (MESALAMINE) | — | Small molecule | 2030-05-01 | 1 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2030-10-30 | 1 patents | Formulation |
| olodaterol-hydrochloride (OLODATEROL HYDROCHLORIDE) | — | Small molecule | 2030-10-16 | 1 patents | Formulation |
| chembl-chembl1946170 (REGORAFENIB) | — | Small molecule | 2030-06-02 | 1 patents | Method of Use |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2030-05-25 | 1 patents | Composition of Matter |
| cedazuridine (CEDAZURIDINE) | — | Small molecule | 2030-08-22 | 1 patents | Method of Use |
| tenapanor-hydrochloride (TENAPANOR HYDROCHLORIDE) | — | Small molecule | 2030-05-02 | 1 patents | Method of Use |
| alectinib-hydrochloride (ALECTINIB HYDROCHLORIDE) | — | Small molecule | 2030-06-09 | 1 patents | Formulation |
| ADALIMUMAB (ADALIMUMAB-ADAZ) | SANDOZ INC | Biologic | 2030-10-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AIMOVIG (ERENUMAB) | Amgen | Biologic | 2030-05-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AJOVY (FREMANEZUMAB) | Teva | Biologic | 2030-09-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ASPARLAS (calaspargase) | Pfizer | Biologic | 2030-12-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| CRYSVITA (BUROSUMAB-TWZA) | KYOWA KIRIN | Biologic | 2030-04-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ELZONRIS (TAGRAXOFUSP) | Stemline Therapeeutics Inc | Biologic | 2030-12-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EMGALITY (GALCANEZUMAB) | Eli Lilly | Biologic | 2030-09-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| FULPHILA (PEGFILGRASTIM-JMDB) | MYLAN GMBH | Biologic | 2030-06-04 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| GAMIFANT (Emapalumab-Lzsg) | Swedish Orphan Biovitrum | Biologic | 2030-11-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| HERZUMA (TRASTUZUMAB-PKRB) | CELLTRION INC | Biologic | 2030-12-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ILUMYA (TILDRAKIZUMAB-ASMN) | SUN PHARMA GLOBAL | Biologic | 2030-03-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Libtayo (CEMIPLIMAB) | Regeneron Pharmaceuticals | Biologic | 2030-09-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NIVESTYM (Filgrastim-Aafi) | Amgen | Biologic | 2030-07-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OXERVATE (CENEGERMIN) | Dompe farmaceutici s.p.a. | Biologic | 2030-08-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PALYNZIQ (Pegvaliase-Pqpz) | University of Missouri-Columbia | Biologic | 2030-05-24 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| POTELIGEO (MOGAMULIZUMAB) | Kyowa Kirin | Biologic | 2030-08-08 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RETACRIT (Epoetin Alfa-Epbx) | Amgen | Biologic | 2030-05-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| REVCOVI (ELAPEGADEMASE) | Leadiant Biosci Inc | Biologic | 2030-10-05 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TAKHZYRO (LANADELUMAB-FLYO) | DYAX CORP. | Biologic | 2030-08-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TROGARZO (IBALIZUMAB) | Taimed Biologics Usa | Biologic | 2030-03-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TRUXIMA (RITUXIMAB-ABBS) | CELLTRION INC | Biologic | 2030-11-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| UDENYCA (Pegfilgrastim-Cbqv) | Coherus Oncology, Inc. | Biologic | 2030-11-02 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ULTOMIRIS (RAVULIZUMAB) | AstraZeneca | Biologic | 2030-12-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | INNATE PHARMA | Biologic | 2030-09-13 | 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.