COSELA Drug Patent Profile

When do Cosela patents expire, and when can generic versions of Cosela launch?

Cosela is a drug marketed by G1 Therap and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in twenty-six countries.

The generic ingredient in COSELA is trilaciclib dihydrochloride. One supplier is listed for this compound. Additional details are available on the trilaciclib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cosela

Cosela will be eligible for patent challenges on February 12, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COSELA

International Patents:	128
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	3
Patent Applications:	276
Drug Prices:	Drug price information for COSELA
What excipients (inactive ingredients) are in COSELA?	COSELA excipients list
DailyMed Link:	COSELA at DailyMed

See drug prices for COSELA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COSELA

NDA:

214200

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COSELA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
G1 Therapeutics, Inc.	Phase 2
G1 Therapeutics, Inc.	Phase 3

See all COSELA clinical trials

Pharmacology for COSELA

Drug Class	Kinase Inhibitor
Mechanism of Action	Cyclin-dependent Kinase 4 Inhibitors Cyclin-dependent Kinase 6 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COSELA

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for COSELA

COSELA is protected by thirteen US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COSELA

FDA Regulatory Exclusivity protecting COSELA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes			Y
G1 Therap	COSELA	trilaciclib dihydrochloride	POWDER;INTRAVENOUS	214200-001	Feb 12, 2021		RX	Yes	Yes

International Patents for COSELA

When does loss-of-exclusivity occur for COSELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Montenegro

Poland

Portugal

Serbia

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COSELA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2019536805	化学療法計画中の免疫応答の保護
World Intellectual Property Organization (WIPO)	2018106729
Hungary	E030714