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 two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for selpercatinib

International Patents:	134
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
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 Dates for selpercatinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for selpercatinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;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

Sponsor	Phase
Massachusetts General Hospital	Phase 2
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company	Phase 1
Eli Lilly and Company	Phase 1

See all selpercatinib clinical trials

Pharmacology for selpercatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors P-Glycoprotein Inhibitors Rearranged during Transfection (RET) Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for selpercatinib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for SELPERCATINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RETEVMO	Capsules	selpercatinib	40 mg and 80 mg	213246	1	2024-05-08

US Patents and Regulatory Information for selpercatinib

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Glossary

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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				⤷ 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
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	TABLET;ORAL	218160-002	Apr 10, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	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

EU/EMA Drug Approvals for selpercatinib

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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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	195573	SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS	⤷ Sign Up
Philippines	12019500775	SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS	⤷ Sign Up
Taiwan	201827428	Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors	⤷ Sign Up
Japan	2022116161	６－（２－ヒドロキシ－２－メチルプロポキシ）－４－（６－（６－（（６－メトキシピリジン－３－イル）メチル）－３，６－ジアザビシクロ［３．１．１］ヘプタン－３－イル）ピリジン－３－イル）ピラゾロ［１，５－Ａ］ピリジン－３－カルボニトリルを含む製剤	⤷ Sign Up
Australia	2018347375	Formulations comprising 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazab icyclo(3.1.1)heptan-3-yl)pyridin-3-yl)pyrazolo(1,5-a)pyridine-3-carbonitrile	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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