| Brand | Active ingredient | Application holder | Expiry | Excl. |
|---|---|---|---|---|
| ADRENALIN | EPINEPHRINE | PH HEALTH LTD | 21 Mar | - |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Aug | - |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 26 Sept | - |
| AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Aug | - |
| ALYFTREK | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | VERTEX PHARMACEUTICALS INC | 14 Feb | ODE-536 |
| AMBELVIST | GADOQUATRANE | BAYER HEALTHCARE PHARMACEUTICALS INC | 21 Nov | NCE |
| ANGIOMAX RTU | BIVALIRUDIN | MAIA PHARMACEUTICALS INC | 20 May | - |
| ANJESO | MELOXICAM | BAUDAX BIO INC | 08 Mar | - |
| ANNOVERA | ETHINYL ESTRADIOL; SEGESTERONE ACETATE | MAYNE PHARMA LLC | 01 Feb | - |
| ANNOVERA | ETHINYL ESTRADIOL; SEGESTERONE ACETATE | MAYNE PHARMA LLC | 21 Jun | - |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | ALKERMES INC | 06 Apr | - |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | ALKERMES INC | 06 Apr | - |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Aug | - |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 26 Sept | - |
| ARMONAIR RESPICLICK | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Aug | - |
| ATTRUBY | ACORAMIDIS HYDROCHLORIDE | BRIDGEBIO PHARMA INC | 22 Mar | ODE-506 |
| ATTRUBY | ACORAMIDIS HYDROCHLORIDE | BRIDGEBIO PHARMA INC | 16 Aug | ODE-506 |
| ATZUMI | DIHYDROERGOTAMINE MESYLATE | SATSUMA PHARMACEUTICALS INC | 11 Dec | NP |
| AZMIRO | TESTOSTERONE CYPIONATE | AZURITY PHARMACEUTICALS INC | 25 Mar | - |
| BAQSIMI | GLUCAGON | AMPHASTAR PHARMACEUTICALS INC | 23 Sept | NPP |
| BEQALZI | SONROTOCLAX | BEONE MEDICINES USA INC | 29 Apr | NCE |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | AMNEAL PHARMACEUTICALS LLC | 26 Feb | - |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | AMNEAL PHARMACEUTICALS LLC | 20 Mar | - |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | AMNEAL PHARMACEUTICALS LLC | 27 May | - |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | AMNEAL PHARMACEUTICALS LLC | 30 Jun | - |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | AMNEAL PHARMACEUTICALS LLC | 24 Aug | - |
| BREXAFEMME | IBREXAFUNGERP CITRATE | GLAXOSMITHKLINE LLC | 10 Jun | GAIN |
| BRINSUPRI | BRENSOCATIB | INSMED INC | 01 Mar | NCE |
| BRUKINSA | ZANUBRUTINIB | BEONE MEDICINES USA INC | 24 Jun | ODE-467 |
| BYLVAY | ODEVIXIBAT | IPSEN BIOPHARMACEUTICALS INC | 20 Jun | ODE-436 |
| CAMCEVI ETM | LEUPROLIDE MESYLATE | ACCORD BIOPHARMA INC | 01 Jan | NS |
| CAMCEVI KIT | LEUPROLIDE MESYLATE | ACCORD BIOPHARMA INC | 01 Jan | - |
| CAPLYTA | LUMATEPERONE TOSYLATE | INTRA-CELLULAR THERAPIES INC | 15 Mar | M-319 |
| CAPLYTA | LUMATEPERONE TOSYLATE | INTRA-CELLULAR THERAPIES INC | 30 Aug | M-319 |
| CAPLYTA | LUMATEPERONE TOSYLATE | INTRA-CELLULAR THERAPIES INC | 27 Oct | M-319 |
| COBENFY | TROSPIUM CHLORIDE; XANOMELINE TARTRATE | BRISTOL-MYERS SQUIBB CO | 27 Sept | NCE |
| COBENFY | TROSPIUM CHLORIDE; XANOMELINE TARTRATE | BRISTOL-MYERS SQUIBB CO | 29 Oct | NCE |
| COMBOGESIC | ACETAMINOPHEN; IBUPROFEN | AFT PHARMACEUTICALS US INC | 27 Feb | NP |
| CONTEPO | FOSFOMYCIN DISODIUM | MEITHEAL PHARMACEUTICALS INC | 30 Jan | GAIN |
| COSELA | TRILACICLIB DIHYDROCHLORIDE | PHARMACOSMOS AS | 23 Jul | NCE |
| CUVRIOR | TRIENTINE TETRAHYDROCHLORIDE | ORPHALAN SA | 03 May | ODE-401 |
| CYKLX | ARTICAINE HYDROCHLORIDE | THEA PHARMA INC | 27 Mar | NP |
| DEXYCU KIT | DEXAMETHASONE | EYEPOINT PHARMACEUTICALS INC | 23 Jun | - |
| DHIVY | CARBIDOPA; LEVODOPA | AVION PHARMACEUTICALS LLC | 28 Mar | - |
| EKTERLY | SEBETRALSTAT | KALVISTA PHARMACEUTICALS LTD | 26 Jan | ODE-534 |
| ELCYS | CYSTEINE HYDROCHLORIDE | EXELA PHARMA SCIENCES LLC | 15 Jan | - |
| ELUCIREM | GADOPICLENOL | GUERBET | 06 Aug | NPP |
| EMROSI | MINOCYCLINE HYDROCHLORIDE | JOURNEY MEDICAL CORP | 07 Jan | NP |
| EOHILIA | BUDESONIDE | TAKEDA PHARMACEUTICALS USA INC | 10 Jan | ODE-466 |
| EPIDIOLEX | CANNABIDIOL | JAZZ PHARMACEUTICALS RESEARCH UK LTD | 26 Apr | ODE-326 |
| ERZOFRI | PALIPERIDONE PALMITATE | LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD | 24 Sept | - |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 18 Jul | PED |
| FILSUVEZ | BIRCH TRITERPENES | CHIESI FARMACEUTICI SPA | 04 Jan | ODE-460 |
| FOCINVEZ | FOSAPREPITANT DIMEGLUMINE | STERISCIENCE PTE LTD | 11 Jan | - |
| FOTIVDA | TIVOZANIB HYDROCHLORIDE | AVEO PHARMACEUTICALS INC | 05 Nov | NCE |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 06 Feb | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 16 Feb | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 20 Feb | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 17 Mar | - |
| GALAFOLD | MIGALASTAT HYDROCHLORIDE | AMICUS THERAPEUTICS US LLC | 25 Mar | - |
| GAVRETO | PRALSETINIB | RIGEL PHARMACEUTICALS INC | 03 Apr | ODE-340 |
| ICOTYDE | ICOTROKINRA HYDROCHLORIDE | JANSSEN BIOTECH INC | 12 Jul | NCE |
| IGALMI | DEXMEDETOMIDINE HYDROCHLORIDE | BIOXCEL THERAPEUTICS INC | 26 Jun | M-82 |
| IHEEZO | CHLOROPROCAINE HYDROCHLORIDE | HARROW EYE LLC | 14 May | - |
| IMBRUVICA | IBRUTINIB | PHARMACYCLICS LLC | 14 Jun | PED |
| INGREZZA | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 14 Aug | ODE-440 |
| INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 14 Aug | I-925 |
| INLURIYO | IMLUNESTRANT TOSYLATE | ELI LILLY AND CO | 11 Jul | NCE |
| INREBIC | FEDRATINIB HYDROCHLORIDE | BRISTOL-MYERS SQUIBB CO | 24 Sept | ODE-259 |
| JATENZO | TESTOSTERONE UNDECANOATE | TOLMAR INC | 12 Apr | - |
| JAYPIRCA | PIRTOBRUTINIB | LOXO ONCOLOGY INC | 29 Jul | ODE-518 |
| KATERZIA | AMLODIPINE BENZOATE | AZURITY PHARMACEUTICALS INC | 11 Apr | - |
| KHAPZORY | LEVOLEUCOVORIN | ACROTECH BIOPHARMA INC | 25 Mar | - |
| KONVOMEP | OMEPRAZOLE; SODIUM BICARBONATE | AZURITY PHARMACEUTICALS INC | 16 Jul | - |
| LIFYORLI (COPACKAGED) | RELACORILANT | CORCEPT THERAPEUTICS INC | 18 Dec | NCE |
| LIKMEZ | METRONIDAZOLE | SAPTALIS PHARMACEUTICALS LLC | 16 Jan | - |
| LIKMEZ | METRONIDAZOLE | SAPTALIS PHARMACEUTICALS LLC | 04 Oct | - |
| LUMAKRAS | SOTORASIB | AMGEN INC | 18 Nov | ODE-507 |
| LUMASON | SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES | BRACCO DIAGNOSTICS INC | 15 May | - |
| LUTATHERA | LUTETIUM LU 177 DOTATATE | ADVANCED ACCELERATOR APPLICATIONS USA INC | 25 Jan | PED |
| LYNKUET | ELINZANETANT | BAYER HEALTHCARE PHARMACEUTICALS INC | 13 Mar | NCE |
| LYTGOBI | FUTIBATINIB | TAIHO ONCOLOGY INC | 05 Nov | ODE* |
| LYVISPAH | BACLOFEN | STRIDES PHARMA INTERNATIONAL AG | 29 Jul | - |
| METAXALONE | METAXALONE | PRIMUS PHARMACEUTICALS INC | 29 Jul | - |
| MOUNJARO | TIRZEPATIDE | ELI LILLY AND CO | 14 Jun | NPP |
| MOUNJARO | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | NPP |
| MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | ELI LILLY AND CO | 14 Jun | NPP |
| MOUNJARO (AUTOINJECTOR) | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | NCE |
| MOUNJARO KWIKPEN | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | NPP |
| MYHIBBIN | MYCOPHENOLATE MOFETIL | AZURITY PHARMACEUTICALS INC | 16 Aug | - |
| MYQORZO | AFICAMTEN | CYTOKINETICS INC | 18 Jan | NCE |
| NEFFY | EPINEPHRINE | ARS PHARMACEUTICALS OPERATIONS INC | 06 Feb | - |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | NOREPINEPHRINE BITARTRATE | INFORLIFE SA | 26 Apr | - |
| NOURESS | CYSTEINE HYDROCHLORIDE | BAXTER HEALTHCARE CORP | 15 Jan | - |
| NOURESS | CYSTEINE HYDROCHLORIDE | BAXTER HEALTHCARE CORP | 02 Mar | - |
| NOURESS | CYSTEINE HYDROCHLORIDE | BAXTER HEALTHCARE CORP | 15 Mar | - |
| NUPLAZID | PIMAVANSERIN TARTRATE | ACADIA PHARMACEUTICALS INC | 27 Feb | PED |
| NURTEC ODT | RIMEGEPANT SULFATE | PFIZER INC | 25 Mar | - |
| OGSIVEO | NIROGACESTAT HYDROBROMIDE | SPRINGWORKS THERAPEUTICS INC | 09 Aug | ODE* |
| OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | GLAXOSMITHKLINE LLC | 21 Aug | ODE-441 |
| OMLONTI | OMIDENEPAG ISOPROPYL | OCUVEX THERAPEUTICS INC | 16 Jul | NCE |
| ORIAHNN (COPACKAGED) | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM | ABBVIE INC | 23 Jul | - |
| ORILISSA | ELAGOLIX SODIUM | ABBVIE INC | 23 Jul | - |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | BIOCRYST PHARMACEUTICALS INC | 01 Nov | PED |
| ORLYNVAH | PROBENECID; SULOPENEM ETZADROXIL | ITERUM THERAPEUTICS US LTD | 01 Apr | GAIN |
| ORLYNVAH | PROBENECID; SULOPENEM ETZADROXIL | ITERUM THERAPEUTICS US LTD | 23 Dec | GAIN |
| OZEMPIC | SEMAGLUTIDE | NOVO NORDISK INC | 01 Feb | I-976 |
| OZOBAX | BACLOFEN | METACEL PHARMACEUTICALS LLC | 30 Aug | - |
| PALSONIFY | PALTUSOTINE HYDROCHLORIDE | CRINETICS PHARMACEUTICALS INC | 16 Jan | ODE-537 |
| PEDMARK | SODIUM THIOSULFATE | FENNEC PHARMACEUTICALS INC | 01 Jul | ODE-384 |
| PEMAZYRE | PEMIGATINIB | INCYTE CORP | 03 May | ODE-404 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | GENUS LIFE SCIENCES INC | 07 Mar | - |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | CMP DEVELOPMENT LLC | 19 Apr | - |
| QULIPTA | ATOGEPANT | ABBVIE INC | 06 Jun | NCE |
| QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NORTON WATERFORD LTD | 25 Jan | - |
| QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NORTON WATERFORD LTD | 21 Jul | - |
| RADICAVA ORS | EDARAVONE | SHIONOGI INC | 01 Nov | ODE-144 |
| RETEVMO | SELPERCATINIB | ELI LILLY AND CO | 10 Apr | PED |
| REZLIDHIA | OLUTASIDENIB | RIGEL PHARMACEUTICALS INC | 16 May | ODE-413 |
| REZLIDHIA | OLUTASIDENIB | RIGEL PHARMACEUTICALS INC | 17 Jul | ODE-413 |
| REZLIDHIA | OLUTASIDENIB | RIGEL PHARMACEUTICALS INC | 12 Nov | ODE-413 |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | B BRAUN MEDICAL INC | 22 Jul | - |
| ROMVIMZA | VIMSELTINIB | DECIPHERA PHARMACEUTICALS LLC | 23 Dec | NCE |
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | GLENMARK SPECIALTY SA | 08 Apr | NPP |
| RYTELO | IMETELSTAT SODIUM | GERON CORP | 16 Jun | ODE-482 |
| RYZUMVI | PHENTOLAMINE MESYLATE | FAMYGEN LIFE SCIENCES INC | 25 Oct | NP |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | ALTATHERA PHARMACEUTICALS LLC | 05 Apr | - |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | ALTATHERA PHARMACEUTICALS LLC | 21 Aug | - |
| SPY AGENT GREEN KIT | INDOCYANINE GREEN | NOVADAQ TECHNOLOGIES ULC | 14 Jul | I-911 |
| SUNLENCA | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 15 Jul | NCE |
| SUNOSI | SOLRIAMFETOL HYDROCHLORIDE | AXSOME MALTA LTD | 06 Mar | ODE-254 |
| SYMPAZAN | CLOBAZAM | COSETTE PHARMACEUTICALS INC | 05 Sept | - |
| TAVNEOS | AVACOPAN | CHEMOCENTRYX INC | 27 Nov | ODE-377 |
| TIBSOVO | IVOSIDENIB | SERVIER PHARMACEUTICALS LLC | 07 Jun | ODE-447 |
| TIROSINT-SOL | LEVOTHYROXINE SODIUM | IBSA INSTITUT BIOCHIMIQUE SA | 17 Sept | - |
| TLANDO | TESTOSTERONE UNDECANOATE | VERITY PHARMACEUTICALS INC | 21 Feb | - |
| TRUDHESA | DIHYDROERGOTAMINE MESYLATE | IMPEL PHARMACEUTICALS LLC | 04 Jan | - |
| UPNEEQ | OXYMETAZOLINE HYDROCHLORIDE | RVL PHARMACEUTICALS INC | 16 Dec | - |
| VABOMERE | MEROPENEM; VABORBACTAM | REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC | 06 Apr | GAIN |
| VEKLURY | REMDESIVIR | GILEAD SCIENCES INC | 10 Jan | PED |
| VEVYE | CYCLOSPORINE | HARROW EYE LLC | 11 Oct | NP |
| VIGAFYDE | VIGABATRIN | PYROS PHARMACEUTICALS INC | 16 Aug | - |
| VIZZ | ACECLIDINE HYDROCHLORIDE | LENZ THERAPEUTICS INC | 08 Oct | NCE |
| VORANIGO | VORASIDENIB | SERVIER PHARMACEUTICALS LLC | 16 Jan | ODE-491 |
| VOSTALLY | RAMIPRIL | ROSEMONT PHARMACEUTICALS HOLDINGS INC | 16 Aug | - |
| VTAMA | TAPINAROF | ORGANON LLC | 13 Nov | I-956 |
| VTAMA | TAPINAROF | ORGANON LLC | 18 Dec | I-956 |
| VUITY | PILOCARPINE HYDROCHLORIDE | ABBVIE INC | 24 Apr | D-187 |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 01 Feb | NP |
| WYNZORA | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | MC2 THERAPEUTICS LTD | 18 Mar | - |
| XCOPRI | CENOBAMATE | SK LIFE SCIENCE INC | 16 Jun | - |
| XOFLUZA | BALOXAVIR MARBOXIL | GENENTECH INC | 09 Oct | M-187 |
| YEZTUGO | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 15 Jul | NP |
| YUPELRI | REVEFENACIN | MYLAN IRELAND LTD | 29 Aug | - |
| YUPELRI | REVEFENACIN | MYLAN IRELAND LTD | 23 Oct | - |
| ZEGFROVY | SUNVOZERTINIB | DIZAL PHARMACEUTICAL CO LTD | 28 Jan | NCE |
| ZEJULA | NIRAPARIB TOSYLATE | GLAXOSMITHKLINE LLC | 25 Jan | - |
| ZEPBOUND | TIRZEPATIDE | ELI LILLY AND CO | 14 Jun | I-958 |
| ZEPBOUND | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | I-958 |
| ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | ELI LILLY AND CO | 14 Jun | I-958 |
| ZEPBOUND (AUTOINJECTOR) | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | I-958 |
| ZEPBOUND KWIKPEN | TIRZEPATIDE | ELI LILLY AND CO | 22 Jul | I-958 |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI PHARMA INC | 24 May | - |
| ZURNAI (AUTOINJECTOR) | NALMEFENE HYDROCHLORIDE | KNOA PHARMA LLC | 05 Nov | NP |
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.