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Last Updated: April 17, 2024

Selpercatinib - Generic Drug Details


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What are the generic sources for selpercatinib and what is the scope of freedom to operate?

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
Eli Lilly and CompanyPhase 1
Loxo Oncology, Inc.Phase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Dominican Republic P2019000090 COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET ⤷  Try a Trial
Eurasian Patent Organization 035568 ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-а]ПИРИДИНОВЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ RET КИНАЗЫ (SUBSTITUTED PYRAZOLO[1,5-a]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS) ⤷  Try a Trial
Serbia 63510 SUPSTITUISANA PIRAZOLO[1,5-A]PIRIDIN JEDINJENJA KAO INHIBITORI RET KINAZE (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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