Drugs facing NCE-1 in 2029
Drugs becoming eligible for first Paragraph IV ANDA filing in 2029
1. Anzupgo patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US8609647 | LEO | Nitrogen-Containing Spirocyclic Compounds And Pharmaceutical Uses Thereof |
Sep, 2031
(5 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2030 |
Drugs and Companies using DELGOCITINIB ingredient
NCE-1 date: 23 July, 2029
Market Authorisation Date: 23 July, 2025
Treatment: Method of inhibiting janus kinase 2 or janus kinase 3 to treat moderate to severe chronic hand eczema (che) in adults who have had an inadequate response to, or for whom topical corticosteroids are no...
Dosage: CREAM
More Information on Dosage
ANZUPGO family patents
2. Avmapki Fakzynja Co-pack (copackaged) patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7897792 | VERASTEM | Coumarin derivative having antitumor activity |
Feb, 2027
(11 months from now) | |
| US8247411 | VERASTEM | Sulfonyl amide derivatives for the treatment of abnormal cell growth |
Apr, 2028
(2 years from now) | |
| US7928109 | VERASTEM | Sulfonyl amide derivatives for the treatment of abnormal cell growth |
Aug, 2029
(3 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11400090 | VERASTEM | Coumarin derivative for therapy or prophylaxis of a cell proliferative disorder |
Oct, 2038
(12 years from now) | |
| US11517573 | VERASTEM | Therapeutic compositions, combinations, and methods of use |
Sep, 2040
(14 years from now) | |
| US12509450 | VERASTEM | Solid Forms Of A Dual Raf/Mek Inhibitor |
Dec, 2042
(16 years from now) | |
| US11873296 | VERASTEM | Solid forms of a dual RAF/MEK inhibitor |
Dec, 2042
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 08, 2030 |
Drugs and Companies using AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE ingredient
NCE-1 date: 08 May, 2029
Market Authorisation Date: 08 May, 2025
Treatment: Treatment of adult patients with kras-mutated recurrent low-grade serous ovarian cancer (lgsoc) who have received prior systemic therapy, in combination with defactinib; Treatment of adult patients wi...
Dosage: CAPSULE, TABLET
More Information on Dosage
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) family patents
3. Blujepa patent
expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US8389524 | GLAXOSMITHKLINE | Tricyclic nitrogen containing compounds as antibacterial agents |
Feb, 2029
(2 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11229646 | GLAXOSMITHKLINE | Method For Treating Gonorrhea With (2R)-2-({4-[(3,4-Dihydro-2H-Pyrano[2,3-C]Pyridin-6-Ylmethyl)Amino]-1-Piperidinyl}Methyl)-1,2-Dihydro-3H,8H-2A,5,8A-Triazaacenaphthylene-3,8-Dione |
Aug, 2035
(9 years from now) | |
| US10702521 | GLAXOSMITHKLINE | Methods For Treating Neisseria Gonorrhoeae Infection With Substituted 1,2-Dihydro-2A,5,8A-Triazaacenaphthylene-3,8-Diones |
Aug, 2035
(9 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-978) | Dec 11, 2028 |
| New Chemical Entity Exclusivity(NCE) | Mar 25, 2030 |
| Generating Antibiotic Incentives Now(GAIN) | Mar 25, 2035 |
Drugs and Companies using GEPOTIDACIN MESYLATE ingredient
NCE-1 date: 25 March, 2029
Market Authorisation Date: 25 March, 2025
Treatment: Treatment of adult and pediatric patients 12 years of age and older weighing at least 45 kg who have limited or no alternative options with uncomplicated urogenital gonorrhea caused by susceptible str...
Dosage: TABLET
More Information on Dosage
BLUJEPA family patents
4. Brinsupri patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US11655222 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11814359 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11655223 | INSMED | Certain (2S)-N-[(1 S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US10669245 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US12054465 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US10287258 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US9522894 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Mar, 2035
(9 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9815805 | INSMED | Certain (25)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11655221 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11673871 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11773069 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US11655224 | INSMED | Certain (2S)-N-[(1S)-1-Cyano-2-Phenylethyl]-1,4-Oxazepane-2-Carboxamides As Dipeptidyl Peptidase 1 Inhibitors |
Jan, 2035
(8 years from now) | |
| US12201638 | INSMED | Pharmaceutical Compositions Comprising (2S)-N-{(1S)-1-Cyano-2-[4-(3-Methyl-2-Oxo-2,3-Dihydro-1,3-Benzoxazol-5-Yl)Phenyl]Ethyl}-1,4-Oxazepane-2-Carboxamide |
Mar, 2039
(13 years from now) | |
| US12059424 | INSMED | Pharmaceutical Compositions Comprising (2S)-N-{(1S)-1-Cyano-2-[4-(3-Methyl-2-Oxo-2,3-Dihydro-1,3-Benzoxazol-5-Yl)Phenyl]Ethyl}-1,4-Oxazepane-2-Carboxamide |
Feb, 2040
(13 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 12, 2030 |
Drugs and Companies using BRENSOCATIB ingredient
NCE-1 date: 12 August, 2029
Market Authorisation Date: 12 August, 2025
Treatment: Treatment of non-cystic fibrosis bronchiectasis in patients 12 years of age and older
Dosage: TABLET
More Information on Dosage
BRINSUPRI family patents
5. Cardamyst patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US10010523 | MILESTONE | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9463179 | MILESTONE | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | |
| US10010522 | MILESTONE | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | |
| US9227918 | MILESTONE | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | |
| US10117848 | MILESTONE | Highly Water-Soluble Salts Of A Short Acting Phenylalkylamine Calcium Channel Blocker And Uses Thereof |
Apr, 2036
(10 years from now) | |
| US12257224 | MILESTONE | Methods Of Administration For Highly Water-Soluble Salts Of A Short Acting Phenylalkylamine Calcium Channel Blocker |
Jul, 2042
(16 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2030 |
Drugs and Companies using ETRIPAMIL ingredient
NCE-1 date: 12 December, 2029
Market Authorisation Date: 12 December, 2025
Treatment: Treatment of a cardiac arrhythmia; Treatment of paroxysmal supraventricular tachycardia
Dosage: SPRAY
More Information on Dosage
CARDAMYST family patents
6. Ekterly patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US11001578 | KALVISTA | N-((Het)Arylmethyl)-Heteroaryl-Carboxamides Compounds As Plasma Kallikrein Inhibitors |
Nov, 2035
(9 years from now) | |
| US10364238 | KALVISTA | N-((Het) Arylmethyl)-Heteroaryl-Carboxamides Compounds As Plasma Kallikrein Inhibitors |
Nov, 2035
(9 years from now) | |
| US11084809 | KALVISTA | N-((Het)Arylmethyl)-Heteroaryl-Carboxamides Compounds As Kallikrein Inhibitors |
Nov, 2035
(9 years from now) | |
| US11230537 | KALVISTA | Polymorphs Of N-[(3-Fluoro-4-Methoxypyridin-2-Yl)Methyl]-3-(Methoxymethyl)-1-({4-[2-Oxopyridin-1-Yl)Methyl]Phenyl} Methyl)Pyrazole-4-Carboxamide As Iallikrein Inhibitors |
Dec, 2037
(11 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11198691 | KALVISTA | N-((Het)Arylmethyl)-Heteroaryl-Carboxamides Compounds As Kallikrein Inhibitors |
Nov, 2035
(9 years from now) | |
| US10611758 | KALVISTA | N-((Het)Arylmethyl)-Heteroaryl-Carboxamides Compounds As Kallikrein Inhibitors |
Nov, 2035
(9 years from now) | |
| US11739068 | KALVISTA | Polymorphs Of N-[(3-Fluoro-4-Methoxypyridin-2-Yl)Methyl]-3-(Methoxymethyl)-1-({4-[(2-Oxopyridin-1-Yl)Methyl]Phenyl}Methyl)Pyrazole-4-Carboxamide And Salts Thereof |
Jun, 2037
(11 years from now) | |
| US11234939 | KALVISTA | Dosage Forms Comprising A Plasma Kallikrein Inhibitor |
Jan, 2039
(12 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 03, 2030 |
Drugs and Companies using SEBETRALSTAT ingredient
NCE-1 date: 03 July, 2029
Market Authorisation Date: 03 July, 2025
Treatment: Treatment of acute attacks of hereditary angioedema (hae) in adults and pediatric patients 12 years of age and older
Dosage: TABLET
More Information on Dosage
EKTERLY family patents
7. Forzinity patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7576061 | STEALTH BIOTHERAPS | Methods For Preventing Mitochondrial Permeability Transition |
Jan, 2027
(10 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11771734 | STEALTH BIOTHERAPS | Methods And Compositions For The Prevention Or Treatment Of Barth Syndrome |
Feb, 2034
(8 years from now) | |
| US11083772 | STEALTH BIOTHERAPS | Methods And Compositions For The Prevention Or Treatment Of Barth Syndrome |
Feb, 2034
(8 years from now) | |
| US12268724 | STEALTH BIOTHERAPS | Methods And Compositions For The Prevention Or Treatment Of Barth Syndrome |
Feb, 2034
(8 years from now) | |
| US9687519 | STEALTH BIOTHERAPS | Methods And Compositions For The Prevention Or Treatment Of Barth Syndrome |
Feb, 2034
(8 years from now) | |
| US11083771 | STEALTH BIOTHERAPS | Methods And Compositions For The Prevention Or Treatment Of Barth Syndrome |
Feb, 2034
(8 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 19, 2030 |
Drugs and Companies using ELAMIPRETIDE HYDROCHLORIDE ingredient
NCE-1 date: 19 September, 2029
Market Authorisation Date: 19 September, 2025
Treatment: Method for treating barth syndrome in adult and pediatric patients weighing at least 30kg
Dosage: SOLUTION
More Information on Dosage
FORZINITY family patents
8. Gomekli patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US11084780 | SPRINGWORKS | Door construction |
Feb, 2041
(14 years from now) | |
| US11066358 | SPRINGWORKS | Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof |
Feb, 2041
(14 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US12295925 | SPRINGWORKS | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 years from now) | |
| US11819487 | SPRINGWORKS | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 years from now) | |
| US11806321 | SPRINGWORKS | Non-linear dosing of mirdametinib |
Feb, 2041
(14 years from now) | |
| US11453641 | SPRINGWORKS | Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide |
Feb, 2041
(14 years from now) | |
| US12263146 | SPRINGWORKS | Non-linear dosing of mirdametinib |
Feb, 2041
(14 years from now) | |
| US12275688 | SPRINGWORKS | Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof |
Feb, 2041
(14 years from now) | |
| US12011424 | SPRINGWORKS | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 years from now) | |
| US12090128 | SPRINGWORKS | Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof |
Feb, 2041
(14 years from now) | |
| US12037306 | SPRINGWORKS | Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide |
Feb, 2041
(14 years from now) | |
| US11571402 | SPRINGWORKS | Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof |
Feb, 2041
(14 years from now) | |
| US12357597 | SPRINGWORKS | Dispersible Formulations Of N-((R)-2,3-Dihydroxypropoxy)-3,4-Difluoro-2-(2-Fluoro-4-Iodo-Phenylamino)-Benazmide And Uses Thereof |
Feb, 2041
(14 years from now) | |
| US12220390 | SPRINGWORKS | Mirdametinib treatment |
Mar, 2043
(17 years from now) | |
| US11839595 | SPRINGWORKS | Mirdametinib treatment |
Mar, 2043
(17 years from now) | |
| US11883375 | SPRINGWORKS | Mirdametinib treatment |
Mar, 2043
(17 years from now) | |
| US12257215 | SPRINGWORKS | Mirdametinib treatment |
Mar, 2043
(17 years from now) | |
| US12324791 | SPRINGWORKS | Mirdametinib treatment |
Mar, 2043
(17 years from now) | |
| US11806322 | SPRINGWORKS | Mirdametinib treatment |
Apr, 2043
(17 years from now) | |
| US12383517 | SPRINGWORKS | Dosage Forms Of Mirdametinib |
Mar, 2044
(18 years from now) | |
| US12029711 | SPRINGWORKS | Dosage forms of mirdametinib |
Mar, 2044
(18 years from now) | |
| US12390430 | SPRINGWORKS | NA |
Oct, 2044
(18 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 11, 2030 |
| Orphan Drug Exclusivity(ODE-488) | Feb 11, 2032 |
Drugs and Companies using MIRDAMETINIB ingredient
NCE-1 date: 11 February, 2029
Market Authorisation Date: 11 February, 2025
Treatment: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (nf1) who have symptomatic plexiform neurofibromas (pn) not amenable to complete resection
Dosage: CAPSULE; TABLET, FOR SUSPENSION
More Information on Dosage
GOMEKLI family patents
9. Grafapex patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US7199162 | MEDEXUS | Use of treosulfan for patient conditioning before bone marrow or blood stem cell transplantation |
Mar, 2026
(22 days from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2030 |
| Orphan Drug Exclusivity(ODE-513) | Jan 21, 2032 |
| Orphan Drug Exclusivity(ODE-514) | Jan 21, 2032 |
Drugs and Companies using TREOSULFAN ingredient
NCE-1 date: 21 January, 2029
Market Authorisation Date: 21 January, 2025
Treatment: Administering treosulfan as a preparative regimen for allogeneic stem cell transplantation
Dosage: POWDER
More Information on Dosage
GRAFAPEX family patents
10. Hernexeos patent expiration
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US12171739 | BOEHRINGER INGELHEIM | N4-Phenyl-Quinazoline-4-Amine Derivatives And Related Compounds As Erbb Type I Receptor Tyrosine Kinase Inhibitors For The Treatment Of Hyperproliferative Diseases |
Nov, 2026
(8 months from now) | |
| US11608343 | BOEHRINGER INGELHEIM | Substituted Pyrimido[5,4-D]Pyrimidines As Her2 Inhibitors |
Jul, 2041
(15 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 08, 2030 |
Drugs and Companies using ZONGERTINIB ingredient
NCE-1 date: 08 August, 2029
Market Authorisation Date: 08 August, 2025
Treatment: Use of zongertinib for treating non-small cell lung cancer (nsclc)
Dosage: TABLET
More Information on Dosage
HERNEXEOS family patents