| Brand | Active ingredient | Application holder | Expiry | Excl. |
|---|---|---|---|---|
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | KNOA PHARMA LLC | 19 Nov | - |
| ADLARITY | DONEPEZIL HYDROCHLORIDE | CORIUM LLC | 20 May | - |
| ADLARITY | DONEPEZIL HYDROCHLORIDE | CORIUM LLC | 11 Aug | - |
| AKEEGA | ABIRATERONE ACETATE; NIRAPARIB TOSYLATE | JANSSEN BIOTECH INC | 27 Mar | I-980 |
| ALTRENO | TRETINOIN | DOW PHARMACEUTICAL SCIENCES | 22 Aug | - |
| ALVAIZ | ELTROMBOPAG CHOLINE | TEVA PHARMACEUTICALS INC | 05 Nov | - |
| AQVESME | MITAPIVAT SULFATE | AGIOS PHARMACEUTICALS INC | 21 Nov | ODE-522 |
| ARAZLO | TAZAROTENE | BAUSCH HEALTH US LLC | 11 May | - |
| ASPRUZYO SPRINKLE | RANOLAZINE | SUN PHARMA INDUSTRIES LTD | 24 Jan | - |
| ATTRUBY | ACORAMIDIS HYDROCHLORIDE | BRIDGEBIO PHARMA INC | 16 Feb | ODE-506 |
| AUSTEDO | DEUTETRABENAZINE | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC | 15 Mar | - |
| AUSTEDO | DEUTETRABENAZINE | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC | 15 Sept | - |
| AUSTEDO XR | DEUTETRABENAZINE | TEVA NEUROSCIENCE INC | 15 Mar | - |
| AUSTEDO XR | DEUTETRABENAZINE | TEVA NEUROSCIENCE INC | 15 Sept | - |
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | VERASTEM INC | 29 Oct | ODE-525 |
| BALVERSA | ERDAFITINIB | JANSSEN BIOTECH INC | 02 Feb | I-930 |
| BARHEMSYS | AMISULPRIDE | LXO IRELAND DESIGNATED ACTIVITY CO | 09 Feb | - |
| BREZTRI AEROSPHERE | BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE | ASTRAZENECA AB | 05 Oct | - |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | SUN PHARMACEUTICAL INDUSTRIES LTD | 15 May | - |
| CABENUVA KIT | CABOTEGRAVIR; RILPIVIRINE | VIIV HEALTHCARE CO | 18 Jul | NCE |
| CERDELGA | ELIGLUSTAT TARTRATE | GENZYME CORP | 13 Dec | - |
| CLENPIQ | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | FERRING PHARMACEUTICALS INC | 27 Jan | - |
| CONSENSI | AMLODIPINE BESYLATE; CELECOXIB | PURPLE BIOTECH LTD | 14 Jun | - |
| COTEMPLA XR-ODT | METHYLPHENIDATE | NEOS THERAPEUTICS INC | 25 Jan | - |
| CYSVIEW KIT | HEXAMINOLEVULINATE HYDROCHLORIDE | PHOTOCURE ASA | 04 Jan | - |
| DAPTOMYCIN | DAPTOMYCIN | HIKMA PHARMACEUTICALS USA INC | 28 Aug | - |
| DSUVIA | SUFENTANIL CITRATE | VERTICAL PHARMACEUTICALS LLC | 02 Feb | - |
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 24 Sept | - |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 24 Sept | - |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 24 Sept | - |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 24 Sept | - |
| EMPAVELI | PEGCETACOPLAN | APELLIS PHARMACEUTICALS INC | 09 Apr | ODE-533 |
| EMPAVELI | PEGCETACOPLAN | APELLIS PHARMACEUTICALS INC | 09 Dec | ODE-533 |
| EMPAVELI | PEGCETACOPLAN | APELLIS PHARMACEUTICALS INC | 14 Dec | ODE-533 |
| ERLEADA | APALUTAMIDE | JANSSEN BIOTECH INC | 30 Apr | - |
| ERZOFRI | PALIPERIDONE PALMITATE | LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD | 26 Oct | - |
| EVRYSDI | RISDIPLAM | GENENTECH INC | 01 Oct | ODE-400 |
| EVRYSDI | RISDIPLAM | GENENTECH INC | 04 Oct | M-270 |
| FABHALTA | IPTACOPAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 30 Aug | ODE-524 |
| FERRIPROX | DEFERIPRONE | CHIESI USA INC | 25 Oct | ODE-417 |
| FINTEPLA | FENFLURAMINE HYDROCHLORIDE | UCB INC | 02 Feb | PED |
| FINTEPLA | FENFLURAMINE HYDROCHLORIDE | UCB INC | 29 Dec | PED |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 30 May | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 17 Aug | - |
| GIMOTI | METOCLOPRAMIDE HYDROCHLORIDE | QOL MEDICAL LLC | 17 Nov | - |
| GOCOVRI | AMANTADINE HYDROCHLORIDE | SUPERNUS PHARMACEUTICALS INC | 23 Aug | - |
| IHEEZO | CHLOROPROCAINE HYDROCHLORIDE | HARROW EYE LLC | 15 Sept | - |
| INGREZZA | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 18 Sept | ODE-440 |
| INGREZZA | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 14 Nov | ODE-440 |
| INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 18 Sept | I-925 |
| INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 14 Nov | I-925 |
| INLEXZO | GEMCITABINE HYDROCHLORIDE | JANSSEN BIOTECH INC | 07 Nov | NP |
| ITOVEBI | INAVOLISIB | GENENTECH INC | 26 Apr | NCE |
| ITOVEBI | INAVOLISIB | GENENTECH INC | 14 Jun | NCE |
| JASCAYD | NERANDOMILAST | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 22 Oct | ODE-546 |
| JESDUVROQ | DAPRODUSTAT | GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND | 13 Mar | NCE |
| JULUCA | DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE | VIIV HEALTHCARE CO | 05 Sept | - |
| KLISYRI | TIRBANIBULIN | ALMIRALL LLC | 12 Mar | D-192 |
| KLISYRI | TIRBANIBULIN | ALMIRALL LLC | 07 Sept | D-192 |
| KOMZIFTI | ZIFTOMENIB | KURA ONCOLOGY INC | 06 Sept | NCE |
| KORLYM | MIFEPRISTONE | CORCEPT THERAPEUTICS INC | 22 Aug | - |
| LAZCLUZE | LAZERTINIB MESYLATE | JANSSEN BIOTECH INC | 18 Apr | NCE |
| LENVIMA | LENVATINIB MESYLATE | EISAI INC | 15 May | PED |
| LENVIMA | LENVATINIB MESYLATE | EISAI INC | 15 Nov | PED |
| LEVOLET | LEVOTHYROXINE SODIUM | GENUS LIFE SCIENCES INC | 23 Mar | - |
| LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | 12 Jan | - |
| LIQREV | SILDENAFIL CITRATE | CMP DEVELOPMENT LLC | 24 Dec | - |
| LORBRENA | LORLATINIB | PFIZER INC | 04 Oct | ODE-349 |
| LUMAKRAS | SOTORASIB | AMGEN INC | 21 May | ODE-507 |
| LUMASON | SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES | BRACCO DIAGNOSTICS INC | 06 Jul | - |
| LUTATHERA | LUTETIUM LU 177 DOTATATE | ADVANCED ACCELERATOR APPLICATIONS USA INC | 25 Jul | PED |
| MAVENCLAD | CLADRIBINE | EMD SERONO INC | 23 Nov | - |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | INFORLIFE SA | 20 Jun | - |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | SUMITOMO PHARMA AMERICA INC | 03 May | M-289 |
| NEFFY | EPINEPHRINE | ARS PHARMACEUTICALS OPERATIONS INC | 06 Feb | - |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | LONG GROVE PHARMACEUTICALS LLC | 30 Jan | - |
| NUBEQA | DAROLUTAMIDE | BAYER HEALTHCARE PHARMACEUTICALS INC | 27 Feb | I-971 |
| NUPLAZID | PIMAVANSERIN TARTRATE | ACADIA PHARMACEUTICALS INC | 27 Aug | PED |
| NYMALIZE | NIMODIPINE | AZURITY PHARMACEUTICALS INC | 16 Apr | - |
| OMLONTI | OMIDENEPAG ISOPROPYL | OCUVEX THERAPEUTICS INC | 27 Dec | NCE |
| OPFOLDA | MIGLUSTAT | AMICUS THERAPEUTICS US LLC | 16 Sept | NP |
| OPVEE | NALMEFENE HYDROCHLORIDE | INDIVIOR INC | 10 Jul | NP |
| ORIAHNN (COPACKAGED) | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM | ABBVIE INC | 20 Aug | - |
| ORILISSA | ELAGOLIX SODIUM | ABBVIE INC | 19 Apr | - |
| ORILISSA | ELAGOLIX SODIUM | ABBVIE INC | 20 Aug | - |
| ORSERDU | ELACESTRANT HYDROCHLORIDE | STEMLINE THERAPEUTICS INC | 05 Jan | NCE |
| OSMOLEX ER | AMANTADINE HYDROCHLORIDE | SUPERNUS PHARMACEUTICALS INC | 15 Feb | - |
| OTIPRIO | CIPROFLOXACIN | ALK-ABELLO INC | 27 Nov | - |
| OXLUMO | LUMASIRAN SODIUM | ALNYLAM PHARMACEUTICALS INC | 20 Nov | ODE-415 |
| OZEMPIC | SEMAGLUTIDE | NOVO NORDISK INC | 24 Aug | - |
| OZEMPIC | SEMAGLUTIDE | NOVO NORDISK INC | 10 Oct | I-961 |
| POSLUMA | FLOTUFOLASTAT F-18 GALLIUM | BLUE EARTH DIAGNOSTICS LTD | 23 Aug | NCE |
| POSLUMA | FLOTUFOLASTAT F-18 GALLIUM | BLUE EARTH DIAGNOSTICS LTD | 22 Nov | NCE |
| PREVDUO | GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE | AZURITY PHARMACEUTICALS INC | 25 Oct | - |
| PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | AMNEAL PHARMACEUTICALS LLC | 18 Jun | - |
| PYRUKYND | MITAPIVAT SULFATE | AGIOS PHARMACEUTICALS INC | 11 Oct | ODE-392 |
| PYRUKYND | MITAPIVAT SULFATE | AGIOS PHARMACEUTICALS INC | 21 Nov | ODE-392 |
| QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NORTON WATERFORD LTD | 26 Jan | - |
| REDEMPLO | PLOZASIRAN SODIUM | ARROWHEAD PHARMACEUTICALS INC | 10 Sept | ODE-541 |
| RETEVMO | SELPERCATINIB | ELI LILLY AND CO | 10 Apr | PED |
| RETEVMO | SELPERCATINIB | ELI LILLY AND CO | 10 Oct | PED |
| REZZAYO | REZAFUNGIN ACETATE | MUNDIPHARMA GMBH | 11 Jul | GAIN |
| REZZAYO | REZAFUNGIN ACETATE | MUNDIPHARMA GMBH | 14 Jul | GAIN |
| RINVOQ | UPADACITINIB | ABBVIE INC | 09 Mar | ODE-481 |
| RIVFLOZA | NEDOSIRAN SODIUM | NOVO NORDISK INC | 12 Oct | ODE-531 |
| ROZLYTREK | ENTRECTINIB | GENENTECH INC | 18 Jul | ODE-448 |
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | GLENMARK SPECIALTY SA | 03 Sept | NPP |
| SEPHIENCE | SEPIAPTERIN | PTC THERAPEUTICS INC | 16 Apr | ODE-542 |
| SEPHIENCE | SEPIAPTERIN | PTC THERAPEUTICS INC | 04 Sept | ODE-542 |
| SINCALIDE | SINCALIDE | MAIA PHARMACEUTICALS INC | 20 Apr | - |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | ALTATHERA PHARMACEUTICALS LLC | 14 Aug | - |
| SUBLOCADE | BUPRENORPHINE | INDIVIOR INC | 22 Jun | M-314 |
| SUNLENCA | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 16 Aug | NCE |
| SUNOSI | SOLRIAMFETOL HYDROCHLORIDE | AXSOME MALTA LTD | 01 Jun | ODE-254 |
| SUNOSI | SOLRIAMFETOL HYDROCHLORIDE | AXSOME MALTA LTD | 01 Nov | ODE-254 |
| SYFOVRE | PEGCETACOPLAN | APELLIS PHARMACEUTICALS INC | 14 Dec | NCE |
| SYMBRAVO | MELOXICAM; RIZATRIPTAN BENZOATE | AXSOME THERAPEUTICS INC | 18 May | NP |
| SYMTUZA | COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | JANSSEN PRODUCTS LP | 19 Jul | - |
| TADLIQ | TADALAFIL | CMP DEVELOPMENT LLC | 24 Dec | - |
| TAFINLAR | DABRAFENIB MESYLATE | NOVARTIS PHARMACEUTICALS CORP | 29 Jun | PED |
| TAFINLAR | DABRAFENIB MESYLATE | NOVARTIS PHARMACEUTICALS CORP | 29 Dec | PED |
| TAZVERIK | TAZEMETOSTAT HYDROBROMIDE | EPIZYME INC | 03 May | ODE-314 |
| THIOLA EC | TIOPRONIN | MISSION PHARMACAL CO | 14 Nov | ODE* |
| TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | VERTEX PHARMACEUTICALS INC | 17 Jul | ODE-543 |
| TRYVIO | APROCITENTAN | IDORSIA PHARMACEUTICALS LTD | 26 Feb | NCE |
| TRYVIO | APROCITENTAN | IDORSIA PHARMACEUTICALS LTD | 02 Mar | NCE |
| TRYVIO | APROCITENTAN | IDORSIA PHARMACEUTICALS LTD | 26 Jul | NCE |
| TUKYSA | TUCATINIB | SEAGEN INC | 27 Apr | ODE-422 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | DAIICHI SANKYO INC | 24 Jul | ODE-250 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | MAYNE PHARMA LLC | 12 Jul | - |
| TYMLOS | ABALOPARATIDE | RADIUS HEALTH INC | 30 Apr | - |
| UTEBZI | TEBIPENEM PIVOXIL HYDROBROMIDE | GLAXOSMITHKLINE LLC | 06 Feb | GAIN |
| VABOMERE | MEROPENEM; VABORBACTAM | REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC | 08 Jan | GAIN |
| VEKLURY | REMDESIVIR | GILEAD SCIENCES INC | 10 Jul | PED |
| VEPPANU | VEPDEGESTRANT | RIGEL PHARMACEUTICALS INC | 30 Jan | NCE |
| VEVYE | CYCLOSPORINE | HARROW EYE LLC | 20 Nov | NP |
| VOYDEYA | DANICOPAN | ALEXION PHARMACEUTICALS INC | 02 Aug | ODE-476 |
| VTAMA | TAPINAROF | ORGANON LLC | 13 Nov | I-956 |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 24 Aug | - |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 10 Oct | - |
| WEGOVY FLEXTOUCH | SEMAGLUTIDE | NOVO NORDISK INC | 10 Oct | I-973 |
| WEGOVY HD | SEMAGLUTIDE | NOVO NORDISK INC | 24 Aug | NS |
| WEGOVY HD | SEMAGLUTIDE | NOVO NORDISK INC | 10 Oct | NS |
| WIDAPLIK | AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | AZURITY PHARMACEUTICALS INC | 23 Jan | NP |
| XDEMVY | LOTILANER | TARSUS PHARMACEUTICALS INC | 14 Dec | NCE |
| XOFLUZA | BALOXAVIR MARBOXIL | GENENTECH INC | 25 Sept | M-187 |
| XOLREMDI | MAVORIXAFOR | X4 PHARMACEUTICALS INC | 11 Dec | ODE-480 |
| YCANTH | CANTHARIDIN | VERRICA PHARMACEUTICALS INC | 22 Aug | NCE |
| YEZTUGO | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 16 Aug | NP |
| ZEJULA | NIRAPARIB TOSYLATE | GLAXOSMITHKLINE LLC | 27 Mar | - |
| ZEPOSIA | OZANIMOD HYDROCHLORIDE | BRISTOL MYERS SQUIBB CO | 30 Sept | M-309 |
| ZONISADE | ZONISAMIDE | AZURITY PHARMACEUTICALS INC | 18 Aug | - |
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.