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Last Updated: November 2, 2024

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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 twelve patents protecting this drug.

This drug has one hundred and thirty-five patent family members in twenty-seven 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 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:135
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 25
Clinical Trials: 4
Drug Prices: Drug price information for COSELA
What excipients (inactive ingredients) are in COSELA?COSELA excipients list
DailyMed Link:COSELA at DailyMed
Drug patent expirations by year for COSELA
Drug Prices for COSELA

See drug prices for COSELA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Merck Sharp & Dohme LLCPhase 2
Wake Forest University Health SciencesPhase 2
G1 Therapeutics, Inc.Phase 2

See all COSELA clinical trials

US Patents and Regulatory Information for COSELA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COSELA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

CDK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

CDK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transient protection of normal cells during chemotherapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A PLATINUM/ETOPOSIDE-CONTAINING REGIMEN THAT INCLUDES AN IMMUNE CHECKPOINT INHIBITOR FOR EXTENSIVE-STAGE SMALL CELL CANCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR REDUCING 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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD FOR REDUCING 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

CDK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Transient protection of normal cells during chemotherapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting COSELA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
G1 Therap COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200-001 Feb 12, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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:

Australia

Patent: 11323739
Patent: CDK inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 16204879
Patent: CDK Inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 18202991
Patent: CDK Inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 20203035
Patent: CDK Inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 20203037
Patent: CDK Inhibitors
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013010018
Patent: inibidores de cdk
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 15084
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 61937
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 3429243
Patent: CDK inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 3936745
Patent: CDK inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 4045654
Patent: CDK inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 6008533
Patent: CDK抑制剂 (CDK Inhibitors)
Estimated Expiration: ⤷  Sign Up

Patent: 6967074
Patent: CDK抑制剂 (CDK inhibitors)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0161092
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18004
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 32467
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 32467
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 55183
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 18203
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 81920
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 67042
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 81770
Patent: INHIBITEURS DE CDK (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 97067
Patent: 抑制劑 (CDK INHIBITORS CDK)
Estimated Expiration: ⤷  Sign Up

Patent: 54345
Patent: CDK抑制劑 (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 30714
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7581
Patent: נגזרות של 6-אוקסו-פיראזינופירולופירימידינים (Derivatives of 6-oxo-pyrazinopyrrolopyrimidines)
Estimated Expiration: ⤷  Sign Up

Patent: 2108
Patent: תרכובות ונגזרות לקטם תלת טבעתי המשמשות כמעכבי cdk ותכשירים רוקחיים המכילים אותן (Tricyclic lactam compounds and derivatives useful as cdk inhibitors and pharmaceutical compositions comprising thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 1977
Patent: מעכבי cdk (Cdk inhibitors)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 23509
Estimated Expiration: ⤷  Sign Up

Patent: 57680
Estimated Expiration: ⤷  Sign Up

Patent: 89926
Estimated Expiration: ⤷  Sign Up

Patent: 13543845
Estimated Expiration: ⤷  Sign Up

Patent: 16183161
Patent: CDK阻害剤 (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 17186357
Patent: CDK阻害剤 (CDK INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 18193400
Patent: CDK阻害剤 (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 32467
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 8327
Patent: INHIBIDORES DE CDK. (CDK INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Patent: 7795
Patent: INHIBIDORES DE CDK. (CDK INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Patent: 13004681
Patent: INHIBIDORES DE CDK. (CDK INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Patent: 19010602
Patent: INHIBIDORES DE CDK. (CDK INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Patent: 20005498
Patent: INHIBIDORES DE CDK. (CDK INHIBITORS.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 32467
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 32467
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 21674
Patent: ИНГИБИТОРЫ CDK (INHIBITORS OF CDK)
Estimated Expiration: ⤷  Sign Up

Patent: 13123790
Patent: ИНГИБИТОРЫ CDK
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600311
Patent: INIBITORI DI CDK
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 135
Patent: CDK INHIBITORI (CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 9525
Patent: CDK INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 201508715Y
Patent: CDK INHIBITORS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 32467
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1929593
Estimated Expiration: ⤷  Sign Up

Patent: 2051881
Estimated Expiration: ⤷  Sign Up

Patent: 2186969
Estimated Expiration: ⤷  Sign Up

Patent: 140003427
Patent: CDK INHIBITORS
Estimated Expiration: ⤷  Sign Up

Patent: 180135086
Patent: CDK 억제제 (CDK CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 190135556
Patent: CDK 억제제 (CDK CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 200137048
Patent: CDK 억제제 (CDK CDK INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 92515
Estimated Expiration: ⤷  Sign Up

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
South Korea 102051881 ⤷  Sign Up
San Marino T201600311 INIBITORI DI CDK ⤷  Sign Up
South Korea 20200137048 CDK 억제제 (CDK CDK INHIBITORS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.