| Brand | Active ingredient | Application holder | Expiry | Excl. |
|---|---|---|---|---|
| ACTHAR GEL | CORTICOTROPIN | MALLINCKRODT PHARMACEUTICALS IRELAND LTD | 18 Jul | - |
| ACTHAR GEL (AUTOINJECTOR) | CORTICOTROPIN | MALLINCKRODT PHARMACEUTICALS IRELAND LTD | 18 Jul | - |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | ACETAMINOPHEN; IBUPROFEN | HALEON US HOLDINGS LLC | 09 Jul | - |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 06 Jan | - |
| APHEXDA | MOTIXAFORTIDE ACETATE | AYRMID PHARMA LTD | 29 Dec | ODE-442 |
| AQVESME | MITAPIVAT SULFATE | AGIOS PHARMACEUTICALS INC | 31 Jul | ODE-522 |
| ARBLI | LOSARTAN POTASSIUM | SCIENTURE LLC | 07 Oct | - |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 06 Jan | - |
| ATZUMI | DIHYDROERGOTAMINE MESYLATE | SATSUMA PHARMACEUTICALS INC | 12 Oct | NP |
| AURLUMYN | ILOPROST | BTG INTERNATIONAL INC | 06 Aug | ODE-465 |
| AUSTEDO XR | DEUTETRABENAZINE | TEVA NEUROSCIENCE INC | 10 Jun | - |
| AUVELITY | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | AXSOME THERAPEUTICS INC | 01 Dec | I-913 |
| BRENZAVVY | BEXAGLIFLOZIN | THERACOSBIO LLC | 05 Oct | NCE |
| BYLVAY | ODEVIXIBAT | IPSEN BIOPHARMACEUTICALS INC | 12 Nov | ODE-436 |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | SUN PHARMACEUTICAL INDUSTRIES LTD | 29 Dec | - |
| CAVHANZA | NILOTINIB | FLEX PHARMA LLC | 29 Jan | - |
| CAVHANZA | NILOTINIB | FLEX PHARMA LLC | 30 Apr | - |
| CRENESSITY | CRINECERFONT | NEUROCRINE BIOSCIENCES INC | 09 Jun | ODE-503 |
| CREXONT | CARBIDOPA; LEVODOPA | IMPAX LABORATORIES LLC | 21 Dec | NP |
| DAPZURA RT | DAPTOMYCIN | BAXTER HEALTHCARE CORP | 11 Mar | - |
| DAYBUE | TROFINETIDE | ACADIA PHARMACEUTICALS INC | 03 Feb | PED |
| DAYBUE STIX | TROFINETIDE | ACADIA PHARMACEUTICALS INC | 03 Feb | PED |
| DETECTNET | COPPER CU-64 DOTATATE | CURIUM US LLC | 03 Sept | ODE-317 |
| DEXTENZA | DEXAMETHASONE | OCULAR THERAPEUTIX INC | 26 Apr | NPP |
| ELIGARD KIT | LEUPROLIDE ACETATE | TOLMAR INC | 22 Dec | - |
| ELIQUIS SPRINKLE | APIXABAN | BRISTOL MYERS SQUIBB CO | 22 May | PED |
| EPIDIOLEX | CANNABIDIOL | JAZZ PHARMACEUTICALS RESEARCH UK LTD | 01 Mar | ODE-326 |
| EPSOLAY | BENZOYL PEROXIDE | MAYNE PHARMA LLC | 23 May | - |
| ERLEADA | APALUTAMIDE | JANSSEN BIOTECH INC | 14 Jan | - |
| EVRYSDI | RISDIPLAM | GENENTECH INC | 15 Apr | M-270 |
| EXPAREL | BUPIVACAINE | PACIRA PHARMACEUTICALS INC | 22 Jan | I-929 |
| FABHALTA | IPTACOPAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 17 May | ODE-524 |
| FABHALTA | IPTACOPAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 25 May | ODE-524 |
| FABHALTA | IPTACOPAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 15 Jul | ODE-524 |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 01 Apr | PED |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 01 Oct | PED |
| FEMLYV | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | MILLICENT MANUFACTURING PR LLC | 24 Jun | NP |
| FENSOLVI KIT | LEUPROLIDE ACETATE | TOLMAR INTERNATIONAL LTD | 22 Dec | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 23 May | - |
| GOMEKLI | MIRDAMETINIB | SPRINGWORKS THERAPEUTICS INC | 17 Feb | ODE-488 |
| HERNEXEOS | ZONGERTINIB | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 21 Jul | NCE |
| HETLIOZ | TASIMELTEON | VANDA PHARMACEUTICALS INC | 21 Feb | ODE-330 |
| HETLIOZ LQ | TASIMELTEON | VANDA PHARMACEUTICALS INC | 21 Feb | ODE-329 |
| ICOTYDE | ICOTROKINRA HYDROCHLORIDE | JANSSEN BIOTECH INC | 14 Jan | NCE |
| ICOTYDE | ICOTROKINRA HYDROCHLORIDE | JANSSEN BIOTECH INC | 19 Nov | NCE |
| INQOVI | CEDAZURIDINE; DECITABINE | TAIHO ONCOLOGY INC | 24 Feb | I-990 |
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | JANSSEN PHARMACEUTICALS INC | 07 May | - |
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | JANSSEN PHARMACEUTICALS INC | 24 Nov | - |
| JAYPIRCA | PIRTOBRUTINIB | LOXO ONCOLOGY INC | 14 Sept | ODE-518 |
| JIDEYTRO | ZIDESAMTINIB | NUVALENT INC | 05 May | - |
| JUXTAPID | LOMITAPIDE MESYLATE | CHIESI FARMACEUTICI SPA | 29 Jul | NS |
| KRAZATI | ADAGRASIB | BRISTOL MYERS SQUIBB CO | 05 Feb | ODE-352 |
| KRAZATI | ADAGRASIB | BRISTOL MYERS SQUIBB CO | 10 Sept | ODE-352 |
| KYPROLIS | CARFILZOMIB | ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC | 29 Apr | PED |
| KYPROLIS | CARFILZOMIB | ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC | 29 Oct | PED |
| KYZATREX | TESTOSTERONE UNDECANOATE | MARIUS PHARMACEUTICALS INC | 29 Mar | - |
| LAZCLUZE | LAZERTINIB MESYLATE | JANSSEN BIOTECH INC | 13 Apr | NCE |
| LAZCLUZE | LAZERTINIB MESYLATE | JANSSEN BIOTECH INC | 01 Aug | NCE |
| LEQSELVI | DEURUXOLITINIB PHOSPHATE | SUN PHARMACEUTICAL INDUSTRIES INC | 21 May | NCE |
| LIFYORLI (COPACKAGED) | RELACORILANT | CORCEPT THERAPEUTICS INC | 26 May | NCE |
| LIFYORLI (COPACKAGED) | RELACORILANT | CORCEPT THERAPEUTICS INC | 22 Dec | NCE |
| LITFULO | RITLECITINIB TOSYLATE | PFIZER INC | 17 Oct | NCE |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | ALKERMES INC | 12 Nov | NCE |
| LYNPARZA | OLAPARIB | ASTRAZENECA PHARMACEUTICALS LP | 25 Oct | ODE-306 |
| LYVISPAH | BACLOFEN | STRIDES PHARMA INTERNATIONAL AG | 29 Sept | - |
| MAVENCLAD | CLADRIBINE | EMD SERONO INC | 10 Sept | - |
| MIPLYFFA | ARIMOCLOMOL CITRATE | ZEVRA DENMARK AS | 19 Nov | ODE-496 |
| MOUNJARO | TIRZEPATIDE | ELI LILLY AND CO | 30 Dec | NPP |
| MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | ELI LILLY AND CO | 30 Dec | NPP |
| MOUNJARO KWIKPEN | TIRZEPATIDE | ELI LILLY AND CO | 30 Dec | NPP |
| MULTRYS | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | AMERICAN REGENT INC | 01 Jul | - |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | NOREPINEPHRINE BITARTRATE | BAXTER HEALTHCARE CORP | 08 Mar | - |
| NORLIQVA | AMLODIPINE BESYLATE | CMP DEVELOPMENT LLC | 24 Feb | - |
| ONYDA XR | CLONIDINE HYDROCHLORIDE | TRIS PHARMA INC | 28 Jul | - |
| OPIPZA | ARIPIPRAZOLE | XIAMEN LP PHARMACUETICAL CO LTD | 15 Dec | - |
| OPZELURA | RUXOLITINIB PHOSPHATE | INCYTE CORP | 05 May | NPP |
| OZEMPIC | SEMAGLUTIDE | NOVO NORDISK INC | 17 Feb | - |
| PALSONIFY | PALTUSOTINE HYDROCHLORIDE | CRINETICS PHARMACEUTICALS INC | 07 Sept | ODE-537 |
| PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | PFIZER INC | 05 Aug | NCE |
| PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | PFIZER INC | 31 Oct | NCE |
| PHYRAGO | DASATINIB | HANDA THERAPEUTICS LLC | 22 Jan | M-307 |
| PLUVICTO | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN | NOVARTIS PHARMACEUTICALS CORP | 18 Sept | I-965 |
| POSIMIR | BUPIVACAINE | INNOCOLL PHARMACEUTICALS LTD | 12 Jan | - |
| POSLUMA | FLOTUFOLASTAT F-18 GALLIUM | BLUE EARTH DIAGNOSTICS LTD | 27 Nov | NCE |
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | FRESENIUS KABI USA LLC | 12 Oct | - |
| PYRUKYND | MITAPIVAT SULFATE | AGIOS PHARMACEUTICALS INC | 31 Jul | ODE-392 |
| QINLOCK | RIPRETINIB | DECIPHERA PHARMACEUTICALS LLC | 08 Feb | ODE-298 |
| QULIPTA | ATOGEPANT | ABBVIE INC | 29 Jul | NCE |
| QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NORTON WATERFORD LTD | 05 May | - |
| QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NORTON WATERFORD LTD | 19 Aug | - |
| RADICAVA ORS | EDARAVONE | SHIONOGI INC | 12 Nov | ODE-144 |
| REZENOPY | NALOXONE HYDROCHLORIDE | SCIENTURE LLC | 05 Feb | NP |
| SELENIOUS ACID | SELENIOUS ACID | AMERICAN REGENT INC | 01 Jul | - |
| SOLOSEC | SECNIDAZOLE | EVOFEM INC | 11 Dec | GAIN |
| SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | HIKMA PHARMACEUTICALS USA INC | 02 Nov | - |
| SUNLENCA | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 28 Aug | NCE |
| SYMBRAVO | MELOXICAM; RIZATRIPTAN BENZOATE | AXSOME THERAPEUTICS INC | 29 Dec | NP |
| TEPYLUTE | THIOTEPA | SHORLA PHARMA LTD | 16 Aug | - |
| TEZRULY | TERAZOSIN HYDROCHLORIDE | NOVITIUM PHARMA LLC | 01 Feb | - |
| TLANDO | TESTOSTERONE UNDECANOATE | VERITY PHARMACEUTICALS INC | 28 Apr | - |
| TRALEMENT | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | AMERICAN REGENT INC | 01 Jul | - |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | MAYNE PHARMA LLC | 23 May | - |
| UBRELVY | UBROGEPANT | ABBVIE INC | 22 Dec | - |
| VANRAFIA | ATRASENTAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 02 Mar | NCE |
| VEKLURY | REMDESIVIR | GILEAD SCIENCES INC | 28 May | PED |
| VEKLURY | REMDESIVIR | GILEAD SCIENCES INC | 28 Nov | PED |
| VYLEESI (AUTOINJECTOR) | BREMELANOTIDE ACETATE | COSETTE PHARMACEUTICALS INC | 29 Apr | - |
| WAYRILZ | RILZABRUTINIB | GENZYME CORP | 20 Feb | ODE-552 |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 17 Feb | I-973 |
| WEGOVY HD | SEMAGLUTIDE | NOVO NORDISK INC | 17 Feb | NS |
| XIFYRM | MELOXICAM | AZURITY PHARMACEUTICALS INC | 31 Jul | - |
| XOFLUZA | BALOXAVIR MARBOXIL | GENENTECH INC | 21 Apr | M-187 |
| XROMI | HYDROXYUREA | NOVA LABORATORIES LTD | 23 Dec | ODE-470 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | JAZZ PHARMACEUTICALS IRELAND LTD | 22 Feb | ODE-369 |
| YCANTH | CANTHARIDIN | VERRICA PHARMACEUTICALS INC | 19 Feb | NCE |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI PHARMA INC | 14 Jun | - |
| ZORYVE | ROFLUMILAST | ARCUTIS BIOTHERAPEUTICS INC | 03 Dec | I-969 |
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.