Selpercatinib - Generic Drug Details

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 eighty patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for selpercatinib

International Patents:	80
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	27
Patent Applications:	142
What excipients (inactive ingredients) are in selpercatinib?	selpercatinib excipients list
DailyMed Link:	selpercatinib at DailyMed

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

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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No			Y
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes			Y
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes				Y

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

International Patents for selpercatinib

Country	Patent Number	Title	Estimated Expiration
Moldova, Republic of	3523301
Japan	7153719
Taiwan	201922741	Crystalline forms
Japan	7079303
Eurasian Patent Organization	202090695	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ
European Patent Office	3753939	COMPOSÉS SUBSTITUÉS DE PYRAZOLO[1,5-A]PYRIDINE EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)