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Last Updated: October 1, 2022

COSELA Drug Patent 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 ten patents protecting this drug.

This drug has one hundred and eight 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 March 14, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COSELA
International Patents:108
US Patents:10
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 18
Clinical Trials: 3
Patent Applications: 282
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

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COSELA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A CARBOPLATIN AND ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A TOPOTECAN-CONTAINING REGIMEN FOR EXTENSIVE- STAGE SMALL CELL LUNG CANCER

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER

Transient protection of normal cells during chemotherapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A TOPOTECAN-CONTAINING REGIMEN FOR EXTENSIVE- STAGE SMALL CELL LUNG CANCER

CDK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting COSELA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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

Patent: 06156
Estimated Expiration: See Plans and Pricing

Patent: 06157
Estimated Expiration: See Plans and Pricing

Patent: 06166
Estimated Expiration: See Plans and Pricing

Patent: 52117
Estimated Expiration: See Plans and Pricing

China

Patent: 5407723
Estimated Expiration: See Plans and Pricing

Patent: 5407889
Estimated Expiration: See Plans and Pricing

Patent: 5473140
Estimated Expiration: See Plans and Pricing

Patent: 7417691
Estimated Expiration: See Plans and Pricing

Patent: 8283644
Estimated Expiration: See Plans and Pricing

Patent: 8434149
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0192168
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68290
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 67050
Estimated Expiration: See Plans and Pricing

Patent: 68290
Estimated Expiration: See Plans and Pricing

Patent: 68291
Estimated Expiration: See Plans and Pricing

Patent: 53209
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 22766
Estimated Expiration: See Plans and Pricing

Patent: 22792
Estimated Expiration: See Plans and Pricing

Patent: 23293
Estimated Expiration: See Plans and Pricing

Patent: 58477
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 46653
Estimated Expiration: See Plans and Pricing

Japan

Patent: 37083
Estimated Expiration: See Plans and Pricing

Patent: 30483
Estimated Expiration: See Plans and Pricing

Patent: 35315
Estimated Expiration: See Plans and Pricing

Patent: 17401
Estimated Expiration: See Plans and Pricing

Patent: 03583
Estimated Expiration: See Plans and Pricing

Patent: 38933
Estimated Expiration: See Plans and Pricing

Patent: 67456
Estimated Expiration: See Plans and Pricing

Patent: 16513737
Estimated Expiration: See Plans and Pricing

Patent: 16514689
Estimated Expiration: See Plans and Pricing

Patent: 16518337
Estimated Expiration: See Plans and Pricing

Patent: 18150333
Estimated Expiration: See Plans and Pricing

Patent: 19055954
Estimated Expiration: See Plans and Pricing

Patent: 19094324
Estimated Expiration: See Plans and Pricing

Patent: 19131609
Estimated Expiration: See Plans and Pricing

Patent: 20128408
Estimated Expiration: See Plans and Pricing

Patent: 20183422
Estimated Expiration: See Plans and Pricing

Patent: 21001197
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 68290
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 557
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68290
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68290
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 790
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68290
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61406
Estimated Expiration: See Plans and Pricing

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
Israel 271977 מעכבי cdk (Cdk inhibitors) See Plans and Pricing
Denmark 2632467 See Plans and Pricing
European Patent Office 3981770 INHIBITEURS DE CDK (CDK INHIBITORS) See Plans and Pricing
Japan 5923509 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.