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 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: | 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 |
|---|---|
| Merck Sharp & Dohme LLC | Phase 2 |
| Wake Forest University Health Sciences | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| G1 Therap | COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200-001 | Feb 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | 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:
Canada
Patent: 06156
Patent: PROTECTION TRANSITOIRE DE CELLULES NORMALES PENDANT UNE CHIMIOTHERAPIE (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 06157
Patent: AGENTS ANTINEOPLASIQUES ET ANTIPROLIFERATIFS HAUTEMENT ACTIFS (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 06166
Patent: TRAITEMENTS EPARGNANT HSPC POUR LA PROLIFERATION CELLULAIRE ANORMALE RB POSITIVE (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Patent: 52117
Patent: AGENTS ANTINEOPLASIQUES ET ANTIPROLIFERATIFS HAUTEMENT ACTIFS (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5407723
Patent: Highly active anti-neoplastic and anti-proliferative agents
Estimated Expiration: ⤷ Sign Up
Patent: 5407889
Patent: HSPC-sparing treatments for Rb-positive abnormal cellular proliferation
Estimated Expiration: ⤷ Sign Up
Patent: 5473140
Patent: Transient protection of normal cells during chemotherapy
Estimated Expiration: ⤷ Sign Up
Patent: 7417691
Patent: 高效的抗赘生剂和抗增生剂 (Highly active anti-neoplastic and anti-proliferative agents)
Estimated Expiration: ⤷ Sign Up
Patent: 8283644
Patent: 在化学疗法期间对正常细胞的瞬时保护 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 8434149
Patent: 针对Rb阳性异常细胞增殖的HSPC节制性治疗 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0192168
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22434
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 68290
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 67050
Patent: AGENTS ANTINÉOPLASIQUES ET ANTIPROLIFÉRATIFS HAUTEMENT ACTIFS (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 68290
Patent: PROTECTION TRANSITOIRE DE CELLULES NORMALES PENDANT UNE CHIMIOTHÉRAPIE (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 68291
Patent: TRAITEMENTS ÉPARGNANT HSPC POUR LA PROLIFÉRATION CELLULAIRE ANORMALE RB POSITIVE (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Patent: 53209
Patent: PROTECTION TRANSITOIRE DE CELLULES NORMALES PENDANT LA CHIMIOTHÉRAPIE (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 22766
Patent: 高效的抗贅生劑和抗增生劑 (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 22792
Patent: 針對 陽性異常細胞增殖的 節制性治療 (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION RB HSPC)
Estimated Expiration: ⤷ Sign Up
Patent: 23293
Patent: 在化學療法期間對正常細胞的瞬時保護 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 58477
Patent: 在化學療法期間對正常細胞的瞬時保護 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 46653
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 37083
Estimated Expiration: ⤷ Sign Up
Patent: 30483
Estimated Expiration: ⤷ Sign Up
Patent: 35315
Estimated Expiration: ⤷ Sign Up
Patent: 17401
Estimated Expiration: ⤷ Sign Up
Patent: 03583
Estimated Expiration: ⤷ Sign Up
Patent: 38933
Estimated Expiration: ⤷ Sign Up
Patent: 67456
Estimated Expiration: ⤷ Sign Up
Patent: 13854
Estimated Expiration: ⤷ Sign Up
Patent: 50737
Estimated Expiration: ⤷ Sign Up
Patent: 16513737
Patent: 化学療法の間の正常細胞の一時的な保護
Estimated Expiration: ⤷ Sign Up
Patent: 16514689
Patent: ＲＢポジティブ異常細胞増殖に対するＨＳＰＣ温存治療
Estimated Expiration: ⤷ Sign Up
Patent: 16518337
Patent: 高活性抗新生物薬及び抗増殖剤
Estimated Expiration: ⤷ Sign Up
Patent: 18150333
Patent: ＲＢポジティブ異常細胞増殖に対するＨＳＰＣ温存治療 (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Patent: 19055954
Patent: 化学療法の間の正常細胞の一時的な保護 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 19094324
Patent: 高活性抗新生物薬及び抗増殖剤 (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 19131609
Patent: ＲＢポジティブ異常細胞増殖に対するＨＳＰＣ温存治療 (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Patent: 20128408
Patent: 高活性抗新生物薬及び抗増殖剤 (HIGHLY ACTIVE ANTI-NEOPLASTIC AND ANTI-PROLIFERATIVE AGENTS)
Estimated Expiration: ⤷ Sign Up
Patent: 20183422
Patent: ＲＢポジティブ異常細胞増殖に対するＨＳＰＣ温存治療 (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Patent: 21001197
Patent: 化学療法の間の正常細胞の一時的な保護 (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 23052449
Patent: 化学療法の間の正常細胞の一時的な保護
Estimated Expiration: ⤷ Sign Up
Patent: 23078341
Patent: ＲＢポジティブ異常細胞増殖に対するＨＳＰＣ温存治療 (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 68290
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 557
Patent: PRIVREMENA ZAŠTIТA NORMALNIH ĆELIJA ТОКОМ HEMOTERAPIJE (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 68290
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 68290
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 790
Patent: PRIVREMENA ZAŠTITA NORMALNIH ĆELIJA TOKOM HEMOTERAPIJE (TRANSIENT PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 68290
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 61406
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 |
|---|---|---|---|
| Russian Federation | 2019120160 | СОХРАНЕНИЕ ИММУННОГО ОТВЕТА ВО ВРЕМЯ ХИМИОТЕРАПЕВТИЧЕСКИХ СХЕМ | ⤷ Sign Up |
| Canada | 2906166 | TRAITEMENTS EPARGNANT HSPC POUR LA PROLIFERATION CELLULAIRE ANORMALE RB POSITIVE (HSPC-SPARING TREATMENTS FOR RB-POSITIVE ABNORMAL CELLULAR PROLIFERATION) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014144740 | ⤷ Sign Up | |
| Slovenia | 2968290 | ⤷ Sign Up | |
| Japan | 2016518337 | 高活性抗新生物薬及び抗増殖剤 | ⤷ Sign Up |
| China | 105473140 | Transient protection of normal cells during chemotherapy | ⤷ 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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