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Last Updated: May 29, 2024

Selpercatinib - Generic Drug Details


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What are the generic drug sources for selpercatinib and what is the scope of patent protection?

Selpercatinib is the generic ingredient in one branded drug marketed by Loxo Oncol Eli Lilly and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selpercatinib has one hundred and thirty-three patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for selpercatinib
International Patents:133
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 28
Patent Applications: 171
What excipients (inactive ingredients) are in selpercatinib?selpercatinib excipients list
DailyMed Link:selpercatinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for selpercatinib
Generic Entry Date for selpercatinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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 selpercatinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 2
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and CompanyPhase 1
Eli Lilly and CompanyPhase 1

See all selpercatinib clinical trials

US Patents and Regulatory Information for selpercatinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No ⤷  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

EU/EMA Drug Approvals for selpercatinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eli Lilly Nederland B.V. Retsevmo selpercatinib EMEA/H/C/005375
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitoradvanced RET fusion-positive thyroid cancer who require systematic therapy following prior treatment
Authorised no no no 2021-02-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for selpercatinib

Country Patent Number Title Estimated Expiration
China 111278822 结晶形式 (CRYSTALLINE FORMS) ⤷  Sign Up
Brazil 112019007144 compostos de pirazolo[1,5-a]piridina substituídos como inibidores da ret cinase ⤷  Sign Up
Hungary E051424 ⤷  Sign Up
Japan 7153719 ⤷  Sign Up
Japan 2021035944 RETキナーゼ阻害剤としての置換ピラゾロ[1,5−A]ピリジン化合物 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS) ⤷  Sign Up
Taiwan I704148 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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