| Brand | Active ingredient | Application holder | Expiry | Excl. |
|---|---|---|---|---|
| AGAMREE | VAMOROLONE | CATALYST PHARMACEUTICALS INC | 17 Mar | ODE-450 |
| AGAMREE | VAMOROLONE | CATALYST PHARMACEUTICALS INC | 16 Jul | ODE-450 |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Feb | - |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 26 Mar | - |
| AIRDUO DIGIHALER | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 06 Jul | - |
| AIRDUO RESPICLICK | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Feb | - |
| ALYFTREK | DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | VERTEX PHARMACEUTICALS INC | 13 Aug | ODE-536 |
| AMBELVIST | GADOQUATRANE | BAYER HEALTHCARE PHARMACEUTICALS INC | 19 May | NCE |
| AMELUZ | AMINOLEVULINIC ACID HYDROCHLORIDE | BIOFRONTERA INC | 15 Oct | D-194 |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Feb | - |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 26 Mar | - |
| ARMONAIR DIGIHALER | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 06 Jul | - |
| ARMONAIR RESPICLICK | FLUTICASONE PROPIONATE | TEVA PHARMACEUTICAL INDUSTRIES LTD | 20 Feb | - |
| ARYNTA | LISDEXAMFETAMINE DIMESYLATE | AZURITY PHARMACEUTICALS INC | 16 Apr | - |
| ARYNTA | LISDEXAMFETAMINE DIMESYLATE | AZURITY PHARMACEUTICALS INC | 30 Aug | - |
| AUVELITY | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | AXSOME THERAPEUTICS INC | 07 Jan | I-913 |
| AUVELITY | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | AXSOME THERAPEUTICS INC | 05 Jun | I-913 |
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | VERASTEM INC | 11 Sept | ODE-525 |
| AYVAKIT | AVAPRITINIB | BLUEPRINT MEDICINES CORP | 10 Apr | ODE-434 |
| BRINSUPRI | BRENSOCATIB | INSMED INC | 21 Feb | NCE |
| BRUKINSA | ZANUBRUTINIB | BEONE MEDICINES USA INC | 10 Jun | ODE* |
| BRYNOVIN | SITAGLIPTIN HYDROCHLORIDE | AZURITY PHARMACEUTICALS INC | 23 Oct | - |
| BYNFEZIA PEN | OCTREOTIDE ACETATE | SUN PHARMACEUTICAL INDUSTRIES LTD | 03 Nov | - |
| CABENUVA KIT | CABOTEGRAVIR; RILPIVIRINE | VIIV HEALTHCARE CO | 01 Oct | NCE |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | BAUSCH HEALTH US LLC | 31 Jul | NP |
| CABTREO | ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | BAUSCH HEALTH US LLC | 28 Dec | NP |
| CAPLYTA | LUMATEPERONE TOSYLATE | INTRA-CELLULAR THERAPIES INC | 07 Jul | M-319 |
| CAPLYTA | LUMATEPERONE TOSYLATE | INTRA-CELLULAR THERAPIES INC | 10 Dec | M-319 |
| CARNEXIV | CARBAMAZEPINE | LUNDBECK PHARMACEUTICALS LLC | 31 Jan | - |
| COSELA | TRILACICLIB DIHYDROCHLORIDE | PHARMACOSMOS AS | 13 Nov | NCE |
| DANZITEN | NILOTINIB TARTRATE | AZURITY PHARMACEUTICALS INC | 18 Feb | - |
| DAYBUE | TROFINETIDE | ACADIA PHARMACEUTICALS INC | 03 Aug | PED |
| DAYBUE STIX | TROFINETIDE | ACADIA PHARMACEUTICALS INC | 03 Aug | PED |
| DUVYZAT | GIVINOSTAT HYDROCHLORIDE | ITALFARMACO SPA | 03 May | ODE-473 |
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 11 Feb | - |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 11 Feb | - |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 11 Feb | - |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | TRIS PHARMA INC | 11 Feb | - |
| ELIQUIS SPRINKLE | APIXABAN | BRISTOL MYERS SQUIBB CO | 22 Nov | PED |
| ELUCIREM | GADOPICLENOL | GUERBET | 17 Jan | NPP |
| EMERPHED | EPHEDRINE SULFATE | NEXUS PHARMACEUTICALS LLC | 16 May | - |
| ENBUMYST | BUMETANIDE | CORSTASIS THERAPEUTICS INC | 04 Dec | - |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | PH HEALTH LTD | 22 Jan | - |
| EPRONTIA | TOPIRAMATE | AZURITY PHARMACEUTICALS INC | 21 Aug | - |
| EPSOLAY | BENZOYL PEROXIDE | MAYNE PHARMA LLC | 19 Feb | - |
| EPSOLAY | BENZOYL PEROXIDE | MAYNE PHARMA LLC | 18 Aug | - |
| EPSOLAY | BENZOYL PEROXIDE | MAYNE PHARMA LLC | 27 Dec | - |
| ERLEADA | APALUTAMIDE | JANSSEN BIOTECH INC | 30 Jan | - |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 18 Jan | PED |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 09 Mar | PED |
| FARXIGA | DAPAGLIFLOZIN | ASTRAZENECA AB | 09 Sept | PED |
| FYARRO | SIROLIMUS | AADI BIOSCIENCES INC | 28 Oct | ODE-386 |
| GEMTESA | VIBEGRON | SUMITOMO PHARMA AMERICA INC | 22 Mar | I-955 |
| GENOSYL | NITRIC OXIDE | VERO BIOTECH INC | 22 Jul | - |
| HETLIOZ LQ | TASIMELTEON | VANDA PHARMACEUTICALS INC | 11 Dec | ODE-329 |
| IGALMI | DEXMEDETOMIDINE HYDROCHLORIDE | BIOXCEL THERAPEUTICS INC | 17 Jul | M-82 |
| IMKELDI | IMATINIB MESYLATE | SHORLA ONCOLOGY | 27 Apr | - |
| INGREZZA | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 10 Aug | ODE-440 |
| INGREZZA SPRINKLE | VALBENAZINE TOSYLATE | NEUROCRINE BIOSCIENCES INC | 10 Aug | I-925 |
| INQOVI | CEDAZURIDINE; DECITABINE | TAIHO ONCOLOGY INC | 07 Oct | I-990 |
| JOURNAVX | SUZETRIGINE | VERTEX PHARMACEUTICALS INC | 04 Dec | NCE |
| KONVOMEP | OMEPRAZOLE; SODIUM BICARBONATE | AZURITY PHARMACEUTICALS INC | 01 Mar | - |
| KYGEVVI | DOXECITINE; DOXRIBTIMINE | UCB INC | 19 Aug | NCE |
| LASIX ONYU | FUROSEMIDE | SQ INNOVATION INC | 03 Jan | - |
| LAZCLUZE | LAZERTINIB MESYLATE | JANSSEN BIOTECH INC | 14 May | NCE |
| LAZCLUZE | LAZERTINIB MESYLATE | JANSSEN BIOTECH INC | 21 May | NCE |
| LIFYORLI (COPACKAGED) | RELACORILANT | CORCEPT THERAPEUTICS INC | 14 Apr | NCE |
| LILETTA | LEVONORGESTREL | MEDICINES360 | 07 Sept | I-917 |
| LIPFENDRA | ENLICITIDE DECANOATE | MERCK SHARP AND DOHME LLC | 04 Feb | NCE |
| LIVMARLI | MARALIXIBAT CHLORIDE | MIRUM PHARMACEUTICALS INC | 12 Feb | I-938 |
| LUMAKRAS | SOTORASIB | AMGEN INC | 20 May | ODE-507 |
| LUMAKRAS | SOTORASIB | AMGEN INC | 15 Sept | ODE-507 |
| MOTPOLY XR | LACOSAMIDE | AUCTA PHARMACEUTICALS INC | 05 Jun | - |
| MYCAPSSA | OCTREOTIDE ACETATE | CHIESI FARMACEUTICI SPA | 28 Dec | ODE-474 |
| NEXLETOL | BEMPEDOIC ACID | ESPERION THERAPEUTICS INC | 19 Jun | I-943 |
| NEXLIZET | BEMPEDOIC ACID; EZETIMIBE | ESPERION THERAPEUTICS INC | 19 Jun | I-943 |
| NUBEQA | DAROLUTAMIDE | BAYER HEALTHCARE PHARMACEUTICALS INC | 02 Jul | I-971 |
| OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | GLAXOSMITHKLINE LLC | 02 Dec | ODE-441 |
| OPIPZA | ARIPIPRAZOLE | XIAMEN LP PHARMACUETICAL CO LTD | 03 Nov | - |
| OPZELURA | RUXOLITINIB PHOSPHATE | INCYTE CORP | 10 Jun | NPP |
| OPZELURA | RUXOLITINIB PHOSPHATE | INCYTE CORP | 28 Jul | NPP |
| OPZELURA | RUXOLITINIB PHOSPHATE | INCYTE CORP | 04 Sept | NPP |
| ORIAHNN (COPACKAGED) | ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM | ABBVIE INC | 27 Aug | - |
| ORILISSA | ELAGOLIX SODIUM | ABBVIE INC | 27 Aug | - |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | BIOCRYST PHARMACEUTICALS INC | 01 May | PED |
| PEMAZYRE | PEMIGATINIB | INCYTE CORP | 30 Aug | ODE-404 |
| PEMAZYRE | PEMIGATINIB | INCYTE CORP | 03 Oct | ODE-404 |
| QAMZOVA | MELOXICAM | NANJING DELOVA BIOTECH CO LTD | 19 Jul | - |
| QDOLO | TRAMADOL HYDROCHLORIDE | ROSEMONT PHARMACEUTICALS LLC | 01 Sept | - |
| QINLOCK | RIPRETINIB | DECIPHERA PHARMACEUTICALS LLC | 12 Aug | ODE-298 |
| QINLOCK | RIPRETINIB | DECIPHERA PHARMACEUTICALS LLC | 30 Dec | ODE-298 |
| RECORLEV | LEVOKETOCONAZOLE | STRONGBRIDGE DUBLIN LTD | 02 Mar | ODE-385 |
| RELYVRIO | SODIUM PHENYLBUTYRATE; TAURURSODIOL | AMYLYX PHARMACEUTICALS INC | 27 Jul | ODE-411 |
| REYVOW | LASMIDITAN SUCCINATE | ELI LILLY AND CO | 06 Jul | - |
| ROMVIMZA | VIMSELTINIB | DECIPHERA PHARMACEUTICALS LLC | 03 Feb | NCE |
| SCEMBLIX | ASCIMINIB HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 14 May | ODE-499 |
| SCEMBLIX | ASCIMINIB HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 17 May | ODE-499 |
| SOFDRA | SOFPIRONIUM BROMIDE | BOTANIX SB INC | 22 May | NCE |
| SPRAVATO | ESKETAMINE HYDROCHLORIDE | JANSSEN PHARMACEUTICALS INC | 18 Feb | I-959 |
| SUBVENITE | LAMOTRIGINE | OWP PHARMACEUTICALS INC | 29 May | - |
| SUNOSI | SOLRIAMFETOL HYDROCHLORIDE | AXSOME MALTA LTD | 19 Mar | ODE-254 |
| SYMBRAVO | MELOXICAM; RIZATRIPTAN BENZOATE | AXSOME THERAPEUTICS INC | 28 May | NP |
| SYMPAZAN | CLOBAZAM | COSETTE PHARMACEUTICALS INC | 31 Jan | - |
| TLANDO | TESTOSTERONE UNDECANOATE | VERITY PHARMACEUTICALS INC | 16 Oct | - |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | MAYNE PHARMA LLC | 27 Dec | - |
| TYMLOS | ABALOPARATIDE | RADIUS HEALTH INC | 10 Jan | - |
| UZEDY | RISPERIDONE | TEVA NEUROSCIENCE INC | 11 Sept | NP |
| VANRAFIA | ATRASENTAN HYDROCHLORIDE | NOVARTIS PHARMACEUTICALS CORP | 16 Dec | NCE |
| VYALEV | FOSCARBIDOPA; FOSLEVODOPA | ABBVIE INC | 10 Jun | NP |
| WAYRILZ | RILZABRUTINIB | GENZYME CORP | 13 Oct | ODE-552 |
| WEGOVY | SEMAGLUTIDE | NOVO NORDISK INC | 13 May | I-973 |
| WEGOVY FLEXTOUCH | SEMAGLUTIDE | NOVO NORDISK INC | 13 May | I-973 |
| XIPERE | TRIAMCINOLONE ACETONIDE | BAUSCH AND LOMB INC | 16 Apr | - |
| YEZTUGO | LENACAPAVIR SODIUM | GILEAD SCIENCES INC | 25 Nov | NP |
| ZEPZELCA | LURBINECTEDIN | JAZZ PHARMACEUTICALS IRELAND LTD | 29 May | I-977 |
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.