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 Pharmacosmos 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COSELA
*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 |
|---|---|
| Wake Forest University Health Sciences | Phase 2 |
| Merck Sharp & Dohme LLC | Phase 2 |
| G1 Therapeutics, Inc. | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200-001 | Feb 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200-001 | Feb 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200-001 | Feb 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacosmos | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200-001 | Feb 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
|---|---|---|---|
| Japan | 6337083 | ⤷ Sign Up | |
| Lithuania | 2968290 | ⤷ Sign Up | |
| South Korea | 20240023676 | 화학요법 레지멘 동안의 면역 반응의 보존 (PRESERVATION OF IMMUNE RESPONSE DURING CHEMOTHERAPY REGIMENS) | ⤷ Sign Up |
| Canada | 2961937 | INHIBITEURS DE 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.
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