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Last Updated: June 25, 2021

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COSELA Drug Profile


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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 eight patents protecting this drug.

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

The generic ingredient in COSELA is trilaciclib dihydrochloride. 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 October 25, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COSELA
International Patents:106
US Patents:8
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 3
Patent Applications: 137
What excipients (inactive ingredients) are in COSELA?COSELA excipients list
DailyMed Link:COSELA at DailyMed
Drug patent expirations by year for COSELA
DrugPatentWatch® Estimated Generic Entry Opportunity Date for COSELA
Generic Entry Date for COSELA*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all COSELA clinical trials

US Patents and Regulatory Information for 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   Get Started Free   Get Started Free   Get Started Free
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Baxter
McKesson
Merck
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.