| Brand | Active ingredient | Application holder | Expiry | Excl. |
|---|---|---|---|---|
| ADLARITY | DONEPEZIL HYDROCHLORIDE | CORIUM LLC | 26 May | - |
| ADLARITY | DONEPEZIL HYDROCHLORIDE | CORIUM LLC | 26 Jul | - |
| ADLARITY | DONEPEZIL HYDROCHLORIDE | CORIUM LLC | 23 Sept | - |
| AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | JANSSEN BIOTECH INC | 28 Jul | I-980 |
| AKYNZEO | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE | HELSINN HEALTHCARE SA | 02 Jun | - |
| AMZEEQ | MINOCYCLINE HYDROCHLORIDE | JOURNEY MEDICAL CORP | 08 Sept | - |
| AQNEURSA | LEVACETYLLEUCINE | INTRABIO INC | 19 Apr | ODE-498 |
| ATORVALIQ | ATORVASTATIN CALCIUM | CMP DEVELOPMENT LLC | 07 Jun | - |
| ATZUMI | DIHYDROERGOTAMINE MESYLATE | SATSUMA PHARMACEUTICALS INC | 04 Aug | NP |
| AUVI-Q | EPINEPHRINE | KALEO INC | 21 Dec | - |
| AZSTARYS | DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE | COMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC | 09 Dec | NCE |
| BLUDIGO | INDIGOTINDISULFONATE SODIUM | PROVEPHARM SAS | 23 Dec | NCE |
| BRUKINSA | ZANUBRUTINIB | BEONE MEDICINES USA INC | 15 Aug | ODE* |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | CALCIUM GLUCONATE | HQ SPECIALTY PHARMA CORP | 25 Jul | - |
| CAMCEVI ETM | LEUPROLIDE MESYLATE | ACCORD BIOPHARMA INC | 18 Dec | NS |
| CAMCEVI KIT | LEUPROLIDE MESYLATE | ACCORD BIOPHARMA INC | 18 Dec | - |
| CEQUA | CYCLOSPORINE | SUN PHARMACEUTICAL INDUSTRIES LTD | 28 Feb | - |
| COSELA | TRILACICLIB DIHYDROCHLORIDE | PHARMACOSMOS AS | 05 Dec | NCE |
| DEFINITY | PERFLUTREN | LANTHEUS MEDICAL IMAGING INC | 16 Mar | - |
| DEFINITY | PERFLUTREN | LANTHEUS MEDICAL IMAGING INC | 04 May | - |
| DEFINITY RT | PERFLUTREN | LANTHEUS MEDICAL IMAGING INC | 16 Mar | - |
| DEFINITY RT | PERFLUTREN | LANTHEUS MEDICAL IMAGING INC | 04 May | - |
| DEXTENZA | DEXAMETHASONE | OCULAR THERAPEUTIX INC | 16 Nov | NPP |
| DRIZALMA SPRINKLE | DULOXETINE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | 13 Apr | - |
| EDURANT PED | RILPIVIRINE HYDROCHLORIDE | JANSSEN PRODUCTS LP | 23 Oct | PED |
| EKTERLY | SEBETRALSTAT | KALVISTA PHARMACEUTICALS LTD | 23 Jun | ODE-534 |
| EKTERLY | SEBETRALSTAT | KALVISTA PHARMACEUTICALS LTD | 25 Dec | ODE-534 |
| ENSACOVE | ENSARTINIB HYDROCHLORIDE | XCOVERY HOLDINGS INC | 01 Jun | NCE |
| ENTRESTO SPRINKLE | SACUBITRIL; VALSARTAN | NOVARTIS PHARMACEUTICALS CORP | 02 Feb | - |
| ESBRIET | PIRFENIDONE | LEGACY PHARMA INC SEZC | 28 Mar | - |
| EVEKEO ODT | AMPHETAMINE SULFATE | AZURITY PHARMACEUTICALS INC | 10 Mar | - |
| FINTEPLA | FENFLURAMINE HYDROCHLORIDE | UCB INC | 20 Jun | PED |
| FINTEPLA | FENFLURAMINE HYDROCHLORIDE | UCB INC | 02 Aug | PED |
| FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | CATALYST PHARMACEUTICALS INC | 25 Feb | ODE-553 |
| FLEQSUVY | BACLOFEN | AZURITY PHARMACEUTICALS INC | 08 Sept | - |
| FLEQSUVY | BACLOFEN | AZURITY PHARMACEUTICALS INC | 29 Sept | - |
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM | BAUSCH AND LOMB IRELAND LTD | 15 Nov | - |
| FOUNDAYO | ORFORGLIPRON CALCIUM | ELI LILLY AND CO | 26 Sept | NCE |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 15 Mar | - |
| GIAPREZA | ANGIOTENSIN II ACETATE | LA JOLLA PHARMA LLC | 06 Jan | - |
| GLOPERBA | COLCHICINE | SCILEX PHARMACEUTICALS INC | 20 Dec | - |
| GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN | BOEHRINGER INGELHEIM | 08 Jun | - |
| GLYXAMBI | EMPAGLIFLOZIN; LINAGLIPTIN | BOEHRINGER INGELHEIM | 08 Dec | - |
| GOPRELTO | COCAINE HYDROCHLORIDE | LXO IRELAND DESIGNATED ACTIVITY CO | 07 Feb | - |
| HEMADY | DEXAMETHASONE | DEXCEL PHARMA TECHNOLOGIES LTD | 18 Dec | ODE-271 |
| IBRANCE | PALBOCICLIB | PFIZER INC | 19 Feb | I-995 |
| IGALMI | DEXMEDETOMIDINE HYDROCHLORIDE | BIOXCEL THERAPEUTICS INC | 29 Dec | M-82 |
| INGREZZA | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 10 Oct | ODE-440 |
| INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 10 Oct | I-925 |
| INLYTA | AXITINIB | PF PRISM CV | 12 Jan | - |
| INLYTA | AXITINIB | PF PRISM CV | 12 Jul | - |
| IQIRVO | ELAFIBRANOR | IPSEN BIOPHARMACEUTICALS INC | 30 Mar | ODE-486 |
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Jun | PED |
| JENTADUETO | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Dec | PED |
| JENTADUETO XR | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Jun | PED |
| JENTADUETO XR | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Dec | PED |
| KATERZIA | AMLODIPINE BENZOATE | AZURITY PHARMACEUTICALS INC | 06 Oct | - |
| KATERZIA | AMLODIPINE BENZOATE | AZURITY PHARMACEUTICALS INC | 16 Oct | - |
| KOMZIFTI | ZIFTOMENIB | KURA ONCOLOGY INC | 26 Jan | NCE |
| KOMZIFTI | ZIFTOMENIB | KURA ONCOLOGY INC | 15 Mar | NCE |
| KORLYM | MIFEPRISTONE | CORCEPT THERAPEUTICS INC | 18 Jan | - |
| KORLYM | MIFEPRISTONE | CORCEPT THERAPEUTICS INC | 19 Jun | - |
| KRAZATI | ADAGRASIB | BRISTOL MYERS SQUIBB CO | 17 May | ODE-352 |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | SUN PHARMACEUTICAL INDUSTRIES INC | 04 May | NCE |
| LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | 17 Jan | - |
| LEXETTE | HALOBETASOL PROPIONATE | MAYNE PHARMA LLC | 30 May | - |
| LONSURF | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE | TAIHO ONCOLOGY INC | 03 Feb | ODE-229 |
| LUMRYZ | SODIUM OXYBATE | AVADEL CNS PHARMACEUTICALS LLC | 21 Jul | ODE-494 |
| LUPKYNIS | VOCLOSPORIN | AURINIA PHARMACEUTICALS INC | 07 Dec | NCE |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | MICAFUNGIN SODIUM | BAXTER HEALTHCARE CORP | 15 Dec | - |
| MIEBO | PERFLUOROHEXYLOCTANE | BAUSCH AND LOMB INC | 21 Jun | NCE |
| MIUDELLA | COPPER | SEBELA WOMENS HEALTH INC | 23 Jan | NP |
| MODEYSO | DORDAVIPRONE HYDROCHLORIDE | CHIMERIX INC | 30 Jan | ODE-547 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | SUMITOMO PHARMA AMERICA INC | 29 Sept | M-289 |
| NUMBRINO | COCAINE HYDROCHLORIDE | OMNIVIUM PHARMACEUTICALS LLC | 07 Feb | - |
| NUPLAZID | PIMAVANSERIN TARTRATE | ACADIA PHARMACEUTICALS INC | 23 Mar | PED |
| NUPLAZID | PIMAVANSERIN TARTRATE | ACADIA PHARMACEUTICALS INC | 23 Sept | PED |
| NUZYRA | OMADACYCLINE TOSYLATE | PARATEK PHARMACEUTICALS INC | 03 Aug | M-320 |
| NUZYRA | OMADACYCLINE TOSYLATE | PARATEK PHARMACEUTICALS INC | 31 Oct | M-320 |
| OPFOLDA | MIGLUSTAT | AMICUS THERAPEUTICS US LLC | 12 Aug | NP |
| ORGOVYX | RELUGOLIX | SUMITOMO PHARMA AMERICA INC | 29 Sept | - |
| ORSERDU | ELACESTRANT HYDROCHLORIDE | STEMLINE THERAPEUTICS INC | 28 Feb | NCE |
| OTIPRIO | CIPROFLOXACIN | ALK-ABELLO INC | 12 Nov | - |
| OXBRYTA | VOXELOTOR | GLOBAL BLOOD THERAPEUTICS INC | 12 Oct | ODE-394 |
| OZEMPIC | SEMAGLUTIDE | NOVO NORDISK INC | 28 Apr | I-961 |
| PALSONIFY | PALTUSOTINE HYDROCHLORIDE | CRINETICS PHARMACEUTICALS INC | 12 Jul | ODE-537 |
| PIZENSY | LACTITOL | BRAINTREE LABORATORIES INC | 12 May | - |
| PROCYSBI | CYSTEAMINE BITARTRATE | HORIZON THERAPEUTICS USA INC | 16 Feb | - |
| PYLARIFY | PIFLUFOLASTAT F-18 | PROGENICS PHARMACEUTICALS INC | 09 Jun | NCE |
| PYLARIFY TRUVU | PIFLUFOLASTAT F-18 | APHELION LLC | 09 Jun | NCE |
| QLOSI | PILOCARPINE HYDROCHLORIDE | ORASIS PHARMACEUTICALS LTD | 18 Aug | NP |
| REDEMPLO | PLOZASIRAN SODIUM | ARROWHEAD PHARMACEUTICALS INC | 07 Mar | ODE-541 |
| RELEXXII | METHYLPHENIDATE HYDROCHLORIDE | OSMOTICA PHARMACEUTICAL US LLC | 03 Feb | - |
| RETEVMO | SELPERCATINIB | ELI LILLY AND CO | 10 Oct | PED |
| REVUFORJ | REVUMENIB CITRATE | SYNDAX PHARMACEUTICALS INC | 08 Jun | ODE-502 |
| REYVOW | LASMIDITAN SUCCINATE | ELI LILLY AND CO | 05 Dec | - |
| REZZAYO | REZAFUNGIN ACETATE | MUNDIPHARMA GMBH | 15 Mar | GAIN |
| ROZLYTREK | ENTRECTINIB | GENENTECH INC | 18 May | ODE-448 |
| SAXENDA | LIRAGLUTIDE | NOVO NORDISK INC | 09 Jan | - |
| SAXENDA | LIRAGLUTIDE | NOVO NORDISK INC | 09 Jul | - |
| SOFDRA | SOFPIRONIUM BROMIDE | BOTANIX SB INC | 20 Jul | NCE |
| SOHONOS | PALOVAROTENE | IPSEN BIOPHARMACEUTICALS INC | 08 Jun | ODE-439 |
| SUNLENCA | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 17 Aug | NCE |
| SUNOSI | SOLRIAMFETOL HYDROCHLORIDE | AXSOME MALTA LTD | 05 Sept | ODE-254 |
| SUTAB | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE | AZURITY PHARMACEUTICALS INC | 04 Aug | - |
| SYFOVRE | PEGCETACOPLAN | APELLIS PHARMACEUTICALS INC | 22 Feb | NCE |
| TEPADINA AND SODIUM CHLORIDE | THIOTEPA | ADIENNE SA | 31 May | - |
| TERLIVAZ | TERLIPRESSIN ACETATE | MALLINCKRODT PHARMACEUTICALS IRELAND LTD | 05 Apr | ODE-406 |
| TIROSINT-SOL | LEVOTHYROXINE SODIUM | IBSA INSTITUT BIOCHIMIQUE SA | 28 Feb | - |
| TLANDO | TESTOSTERONE UNDECANOATE | VERITY PHARMACEUTICALS INC | 28 Nov | - |
| TRADJENTA | LINAGLIPTIN | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Jun | PED |
| TRADJENTA | LINAGLIPTIN | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Dec | PED |
| TRIJARDY XR | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Jun | - |
| TRIJARDY XR | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 08 Dec | - |
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | VERTEX PHARMACEUTICALS INC | 08 Dec | ODE-543 |
| TRYVIO | APROCITENTAN | IDORSIA PHARMACEUTICALS LTD | 06 Nov | NCE |
| UPTRAVI | SELEXIPAG | ACTELION PHARMACEUTICALS US INC | 01 Jun | PED |
| UTEBZI | TEBIPENEM PIVOXIL HYDROBROMIDE | GLAXOSMITHKLINE LLC | 15 Dec | GAIN |
| VEKLURY | REMDESIVIR | GILEAD SCIENCES INC | 16 Mar | PED |
| VEPPANU | VEPDEGESTRANT | RIGEL PHARMACEUTICALS INC | 01 Dec | NCE |
| VEVYE | CYCLOSPORINE | HARROW EYE LLC | 22 Sept | NP |
| VICTOZA | LIRAGLUTIDE | NOVO NORDISK INC | 09 Jan | - |
| VICTOZA | LIRAGLUTIDE | NOVO NORDISK INC | 09 Jul | - |
| VIJOICE | ALPELISIB | NOVARTIS PHARMACEUTICALS CORP | 17 Feb | ODE-396 |
| VITRAKVI | LAROTRECTINIB SULFATE | BAYER HEALTHCARE PHARMACEUTICALS INC | 04 Apr | - |
| VITRAKVI | LAROTRECTINIB SULFATE | BAYER HEALTHCARE PHARMACEUTICALS INC | 16 May | - |
| VOSEVI | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | GILEAD SCIENCES INC | 01 Jun | - |
| VOSEVI | SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR | GILEAD SCIENCES INC | 01 Dec | - |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 28 Apr | - |
| XERAVA | ERAVACYCLINE DIHYDROCHLORIDE | TETRAPHASE PHARMACEUTICALS INC | 19 Oct | GAIN |
| XOFLUZA | BALOXAVIR MARBOXIL | GENENTECH INC | 09 Aug | M-187 |
| XTANDI | ENZALUTAMIDE | ASTELLAS PHARMA US INC | 23 Feb | I-926 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | JAZZ PHARMACEUTICALS IRELAND LTD | 19 Sept | ODE-369 |
| YEZTUGO | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 17 Aug | NP |
| YORVIPATH | PALOPEGTERIPARATIDE | ASCENDIS PHARMA BONE DISEASES AS | 28 Sept | ODE-492 |
| YUTREPIA | TREPROSTINIL SODIUM | LIQUIDIA TECHNOLOGIES INC | 05 May | NP |
| YUVIWEL | NAVEPEGRITIDE | ASCENDIS PHARMA GROWTH DISORDERS AS | 05 Jan | ODE-516 |
| ZORYVE | ROFLUMILAST | ARCUTIS BIOTHERAPEUTICS INC | 07 Jun | NPP |
| ZORYVE | ROFLUMILAST | ARCUTIS BIOTHERAPEUTICS INC | 25 Aug | NS |
| ZTALMY | GANAXOLONE | IMMEDICA PHARMA AB | 10 Aug | ODE-395 |
| ZULRESSO | BREXANOLONE | SAGE THERAPEUTICS LLC A WHOLLY OWNED SUB OF SUPERNUS PHARMACEUTICALS INC | 08 Mar | - |
| ZURZUVAE | ZURANOLONE | BIOGEN INC | 23 Aug | NCE |
| ZYKADIA | CERITINIB | NOVARTIS PHARMACEUTICALS CORP | 13 Dec | - |
Provenance
Source: FDA Orange Book patent and exclusivity files. Rows carrying an exclusivity code have a separate regulatory exclusivity that can outlast the patent shown. Patent expiry alone does not determine when a generic can launch: paediatric extensions, 30-month stays and settlement agreements frequently move the effective date. Delisted patents are excluded.