Pharsight

1. Mavenclad patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14001970A	2018-10-16	Generics (UK) Ltd	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10849919	February, 2023	Terminated-Settled	Ares Trading SA	Hopewell Pharma Ventures, Inc. et al.
US7713947	January, 2023	PO preliminary response filed	Merck Serono SA	Hopewell Pharma Ventures, Inc. et al.
US8377903	January, 2023	PO preliminary response filed	Merck Serono SA	Hopewell Pharma Ventures, Inc. et al.
US7713947	October, 2022	Institution Denied	Merck Serono SA	TWi Pharmaceuticals, Inc.
US8377903	October, 2022	Institution Denied	Merck Serono SA	TWi Pharmaceuticals, Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8785415	EMD SERONO INC	Oral formulations of cladribine	Apr, 2024 (6 months from now)
US7888328	EMD SERONO INC	Oral formulations of cladribine	Apr, 2024 (6 months from now)
US8377903	EMD SERONO INC	Cladribine regimen for treating multiple sclerosis	May, 2026 (2 years from now)
US7713947	EMD SERONO INC	Cladribine regimen for treating multiple sclerosis	Oct, 2026 (3 years from now)
US10849919	EMD SERONO INC	Cladribine regimen for treating progressive forms of multiple sclerosis	Nov, 2038 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product (NP)	Mar 29, 2022

Drugs and Companies using CLADRIBINE ingredient

Market Authorisation Date: 29 March, 2019

Treatment: Treatment of ms with an admixture of (a) an amorphous inclusion complex of cladribine (2cda) and cyclodextrin and (b) amorphous free 2cda and cyclodextrin as a non-inclusion complex, formulated as a s...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg	07 Apr, 2022	1		16 Oct, 2026

Strength	Dosage	Availability
10MG	TABLET;ORAL	Prescription

MAVENCLAD family patents

2. Tepmetko patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8921357	EMD SERONO INC	Pyridazinone derivatives	May, 2028 (4 years from now)
US8329692	EMD SERONO INC	Pyrimidinyl pyridazinone derivatives	Oct, 2029 (6 years from now)
US8580781	EMD SERONO INC	Pyridazinone derivatives	Mar, 2030 (6 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).
US9284300	EMD SERONO INC	Pyridazinone derivatives	Apr, 2028 (4 years from now)
US9403799	EMD SERONO INC	Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase	Jul, 2028 (4 years from now)
US9062029	EMD SERONO INC	Pyrimidinyl pyridazinone derivatives	Jul, 2028 (4 years from now)
US8658643	EMD SERONO INC	Pyrimidinyl pyridazinone derivatives	Jul, 2028 (4 years from now)
US8927540	EMD SERONO INC	Pyridazinone derivatives	Jul, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Feb 3, 2026
Orphan Drug Exclusivity (ODE)	Feb 3, 2028

Drugs and Companies using TEPOTINIB HYDROCHLORIDE ingredient

NCE-1 date: 2025-02-03

Market Authorisation Date: 03 February, 2021

Treatment: Treating a solid tumor, including lung cancer, with a met alteration(s), or stabilizing or improving symptoms associated with having a solid tumor, including lung cancer, with a met alteration(s), by ...

Dosage: TABLET;ORAL