Metastatic Melanoma Therapeutics

1. Braftovi patent expiration

Treatment: Indicated in combination with binimetinib for the treatment of melanoma with a braf mutation; Braftovi is a kinase inhibitor indicated in combination with cetuximab and mfolfox6, for the treatment of ...

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.
US8501758 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US8541575 ARRAY BIOPHARMA INC 3,4-diarylpyrazoles as protein kinase inhibitors
Feb, 2030

(4 years from now)

US8946250 ARRAY BIOPHARMA INC 3,4-diarylpyrazoles as protein kinase inhibitors
Jul, 2029

(3 years from now)

US9593099 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

USRE49556 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Feb, 2030

(4 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).
US9850229 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US9850230 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US9763941 ARRAY BIOPHARMA INC Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Nov, 2032

(6 years from now)

US10005761 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US9314464 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Jul, 2031

(5 years from now)

US10258622 ARRAY BIOPHARMA INC Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate
Nov, 2032

(6 years from now)

US9474754 ARRAY BIOPHARMA INC Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-α inhibitor
Aug, 2033

(7 years from now)

US9387208 ARRAY BIOPHARMA INC Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Nov, 2032

(6 years from now)

US9593100 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-826) Apr 08, 2023
New Chemical Entity Exclusivity(NCE) Jun 27, 2023
Orphan Drug Exclusivity(ODE-194) Jun 27, 2025
New Indication(I-928) Oct 11, 2026
New Indication(I-957) Dec 20, 2027
Orphan Drug Exclusivity(ODE-445) Oct 11, 2030

Drugs and Companies using ENCORAFENIB ingredient

NCE-1 date: 27 June, 2022

Market Authorisation Date: 27 June, 2018

Dosage: CAPSULE

How can I launch a generic of BRAFTOVI before it's drug patent expiration?
More Information on Dosage

BRAFTOVI family patents

Family Patents

2. Cotellic patent expiration

Treatment: Method of using cobimetinib for the treatment of melanoma; As a single agent for the treatment of adult patients with histiocytic neoplasms

COTELLIC's oppositions filed in EPO
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.
US10478400 GENENTECH INC Immediate-release tablets containing combimetinib and methods of making and using the same
Jun, 2036

(10 years from now)

US10590102 GENENTECH INC Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Jun, 2036

(10 years from now)

US11254649 GENENTECH INC Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Jun, 2036

(10 years from now)

US7803839 GENENTECH INC Azetidines as MEK inhibitors for the treatment of proliferative diseases
Nov, 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).
US8362002 GENENTECH INC Azetidines as MEK inhibitors for the treatment of proliferative diseases
Oct, 2026

(8 months from now)

US11597699 GENENTECH INC MEK inhibitors and methods of their use
Oct, 2026

(8 months from now)

US11087354 GENENTECH INC Combination therapies
Jun, 2034

(8 years from now)

US8362002

(Pediatric)

GENENTECH INC Azetidines as MEK inhibitors for the treatment of proliferative diseases
Apr, 2027

(1 year, 2 months from now)

US7803839

(Pediatric)

GENENTECH INC Azetidines as MEK inhibitors for the treatment of proliferative diseases
May, 2030

(4 years from now)

US11254649

(Pediatric)

GENENTECH INC Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Dec, 2036

(10 years from now)

US10478400

(Pediatric)

GENENTECH INC Immediate-release tablets containing combimetinib and methods of making and using the same
Dec, 2036

(10 years from now)

US10590102

(Pediatric)

GENENTECH INC Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone
Dec, 2036

(10 years from now)

US11087354

(Pediatric)

GENENTECH INC Combination therapies
Dec, 2034

(8 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 10, 2020
Orphan Drug Exclusivity(ODE) Nov 10, 2022
Orphan Drug Exclusivity(ODE-101) Nov 10, 2022
M(M-278) Jul 28, 2025
New Indication(I-902) Oct 28, 2025
Pediatric Exclusivity(PED) Jan 28, 2026
Orphan Drug Exclusivity(ODE-416) Oct 28, 2029

Drugs and Companies using COBIMETINIB FUMARATE ingredient

NCE-1 date: 28 January, 2025

Market Authorisation Date: 10 November, 2015

Dosage: TABLET

More Information on Dosage

COTELLIC family patents

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Mekinist patent expiration

Treatment: Mekinist is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test; Me...

MEKINIST's oppositions filed in EPO
Can you believe MEKINIST received compensation for the extended wait time during the regulatory approval process?
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.
US8703781 NOVARTIS Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Oct, 2030

(4 years from now)

US7378423 NOVARTIS Pyrimidine compound and medical use thereof
May, 2027

(1 year, 4 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).
US8952018 NOVARTIS Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Oct, 2030

(4 years from now)

US10869869 NOVARTIS Method of adjuvant cancer treatment
Aug, 2033

(7 years from now)

US8580304 NOVARTIS Pharmaceutical composition
Jan, 2032

(6 years from now)

US8835443 NOVARTIS Pyrimidine compound and medical use thereof
Jun, 2025

(6 months ago)

US9271941 NOVARTIS Pharmaceutical composition
Jan, 2032

(6 years from now)

US9399021 NOVARTIS Pharmaceutical composition
Jan, 2032

(6 years from now)

US9155706 NOVARTIS Pharmaceutical composition
Jan, 2032

(6 years from now)

US7378423

(Pediatric)

NOVARTIS Pyrimidine compound and medical use thereof
Nov, 2027

(1 year, 10 months from now)

US8835443

(Pediatric)

NOVARTIS Pyrimidine compound and medical use thereof
Dec, 2025

(29 days ago)

US8580304

(Pediatric)

NOVARTIS Pharmaceutical composition
Jul, 2032

(6 years from now)

US9155706

(Pediatric)

NOVARTIS Pharmaceutical composition
Jul, 2032

(6 years from now)

US8952018

(Pediatric)

NOVARTIS Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Apr, 2031

(5 years from now)

US9271941

(Pediatric)

NOVARTIS Pharmaceutical composition
Jul, 2032

(6 years from now)

US8703781

(Pediatric)

NOVARTIS Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Apr, 2031

(5 years from now)

US10869869

(Pediatric)

NOVARTIS Method of adjuvant cancer treatment
Feb, 2034

(8 years from now)

US9399021

(Pediatric)

NOVARTIS Pharmaceutical composition
Jul, 2032

(6 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-678) Jan 08, 2017
New Chemical Entity Exclusivity(NCE) May 29, 2018
M(M-170) Nov 20, 2018
Orphan Drug Exclusivity(ODE) May 29, 2020
Orphan Drug Exclusivity(ODE-48) May 29, 2020
New Indication(I-745) Jun 22, 2020
Orphan Drug Exclusivity(ODE-57) Jan 08, 2021
New Indication(I-778) Apr 30, 2021
New Indication(I-781) May 04, 2021
M(M-246) Oct 06, 2022
Orphan Drug Exclusivity(ODE-148) Jun 22, 2024
Orphan Drug Exclusivity(ODE-182) Apr 30, 2025
Orphan Drug Exclusivity(ODE-183) May 04, 2025
New Indication(I-895) Jun 22, 2025
Pediatric Exclusivity(PED) Sep 16, 2026
New Indication(I-908) Mar 16, 2026
New Product(NP) Mar 16, 2026
Orphan Drug Exclusivity(ODE-428) Mar 16, 2030

Drugs and Companies using TRAMETINIB DIMETHYL SULFOXIDE ingredient

NCE-1 date: 22 December, 2024

Market Authorisation Date: 29 May, 2013

Dosage: TABLET; SOLUTION

More Information on Dosage

MEKINIST family patents

Family Patents

4. Mektovi patent expiration

Treatment: Method of treating melanoma; Indicated in combination with encorafenib for the treatment of melanoma; Treatment of melanoma with a braf mutation; Indicated in combination with encorafenib for the trea...

MEKTOVI's oppositions filed in EPO
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.
US8178693 ARRAY BIOPHARMA INC N3 alkylated benzimidazole derivatives as MEK inhibitors
Mar, 2023

(2 years ago)

US7777050 ARRAY BIOPHARMA INC N3 alkylated benzimidazole derivatives as MEK inhibitors
Mar, 2026

(2 months from now)

US9562016 ARRAY BIOPHARMA INC Preparation of and formulation comprising a MEK inhibitor
Oct, 2033

(7 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).
US8193229 ARRAY BIOPHARMA INC Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors
Mar, 2023

(2 years ago)

US9593100 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US8513293 ARRAY BIOPHARMA INC Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal
Mar, 2023

(2 years ago)

US9980944 ARRAY BIOPHARMA INC Preparation of and formulation comprising a MEK inhibitor
Oct, 2033

(7 years from now)

US9850229 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)

US9598376 ARRAY BIOPHARMA INC Preparation of and formulation comprising a MEK inhibitor
Oct, 2033

(7 years from now)

US9314464 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Jul, 2031

(5 years from now)

US10005761 ARRAY BIOPHARMA INC Compounds and compositions as protein kinase inhibitors
Aug, 2030

(4 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 27, 2023
Orphan Drug Exclusivity(ODE-194) Jun 27, 2025
New Indication(I-928) Oct 11, 2026

Drugs and Companies using BINIMETINIB ingredient

NCE-1 date: 27 June, 2022

Market Authorisation Date: 27 June, 2018

Dosage: TABLET

How can I launch a generic of MEKTOVI before it's drug patent expiration?
More Information on Dosage

MEKTOVI family patents

Family Patents

5. Tafinlar patent expiration

Treatment: Tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600...

TAFINLAR's oppositions filed in EPO
Can you believe TAFINLAR received compensation for the extended wait time during the regulatory approval process?
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.
US8415345 NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
Jan, 2030

(4 years from now)

US8703781 NOVARTIS Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Oct, 2030

(4 years from now)

US7994185 NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
Jan, 2030

(4 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).
US9233956 NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
May, 2029

(3 years from now)

US8835443 NOVARTIS Pyrimidine compound and medical use thereof
Jun, 2025

(6 months ago)

US10869869 NOVARTIS Method of adjuvant cancer treatment
Aug, 2033

(7 years from now)

US8952018 NOVARTIS Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Oct, 2030

(4 years from now)

US11504333 NOVARTIS Pharmaceutical composition
Jun, 2038

(12 years from now)

US7994185

(Pediatric)

NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
Jul, 2030

(4 years from now)

US8415345

(Pediatric)

NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
Jul, 2030

(4 years from now)

US9233956

(Pediatric)

NOVARTIS Benzene sulfonamide thiazole and oxazole compounds
Nov, 2029

(3 years from now)

US8835443

(Pediatric)

NOVARTIS Pyrimidine compound and medical use thereof
Dec, 2025

(29 days ago)

US8952018

(Pediatric)

NOVARTIS Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Apr, 2031

(5 years from now)

US8703781

(Pediatric)

NOVARTIS Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Apr, 2031

(5 years from now)

US10869869

(Pediatric)

NOVARTIS Method of adjuvant cancer treatment
Feb, 2034

(8 years from now)

US11504333

(Pediatric)

NOVARTIS Pharmaceutical composition
Dec, 2038

(12 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-678) Jan 08, 2017
New Chemical Entity Exclusivity(NCE) May 29, 2018
M(M-170) Nov 20, 2018
Orphan Drug Exclusivity(ODE) May 29, 2020
Orphan Drug Exclusivity(ODE-47) May 29, 2020
New Indication(I-745) Jun 22, 2020
Orphan Drug Exclusivity(ODE-58) Jan 09, 2021
New Indication(I-778) Apr 30, 2021
New Indication(I-781) May 04, 2021
M(M-246) Oct 06, 2022
Orphan Drug Exclusivity(ODE-147) Jun 22, 2024
Orphan Drug Exclusivity(ODE-182) Apr 30, 2025
Orphan Drug Exclusivity(ODE-183) May 04, 2025
New Indication(I-894) Jun 22, 2025
Pediatric Exclusivity(PED) Sep 16, 2026
New Indication(I-908) Mar 16, 2026
New Product(NP) Mar 16, 2026
Orphan Drug Exclusivity(ODE-428) Mar 16, 2030

Drugs and Companies using DABRAFENIB MESYLATE ingredient

NCE-1 date: 22 December, 2024

Market Authorisation Date: 29 May, 2013

Dosage: CAPSULE; TABLET, FOR SUSPENSION

More Information on Dosage

TAFINLAR family patents

Family Patents

6. Zelboraf patent expiration

Treatment: Treatment of patients with unresectable or metastatic melanoma with brafv600e mutation as detected by an fda approved test

ZELBORAF's oppositions filed in EPO
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.
US8143271 HOFFMANN LA ROCHE NA
Jun, 2026

(5 months from now)

US7863288 HOFFMANN LA ROCHE NA
Jun, 2029

(3 years from now)

US8741920 HOFFMANN LA ROCHE Process for the manufacture of pharmaceutically active compounds
Jul, 2030

(4 years from now)

US7504509 HOFFMANN LA ROCHE Compounds and methods for development of Ret modulators
Oct, 2026

(9 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).
US8470818 HOFFMANN LA ROCHE NA
Aug, 2026

(6 months from now)

US9447089 HOFFMANN LA ROCHE Compositions and uses thereof
Jun, 2032

(6 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 17, 2016
Orphan Drug Exclusivity(ODE) Aug 17, 2018
Orphan Drug Exclusivity(ODE-13) Aug 17, 2018
M(M-184) Aug 31, 2019
New Indication(I-757) Nov 06, 2020
Orphan Drug Exclusivity(ODE-158) Nov 06, 2024

Drugs and Companies using VEMURAFENIB ingredient

NCE-1 date: 18 August, 2015

Market Authorisation Date: 17 August, 2011

Dosage: TABLET

More Information on Dosage

ZELBORAF family patents

Family Patents