Sunitinib malate - Generic Drug Details

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What are the generic sources for sunitinib malate and what is the scope of patent protection?

Sunitinib malate is the generic ingredient in two branded drugs marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, Wanbang Biopharms, and Cppi Cv, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for sunitinib malate. Ten suppliers are listed for this compound.

Sponsor	Phase
Exelixis	Phase 3
VU University Medical Center	Phase 2/Phase 3
Graybug Vision	Phase 2

Sponsor

Phase

Exelixis

Phase 3

VU University Medical Center

Phase 2/Phase 3

Graybug Vision

Phase 2

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUTENT	Capsules	sunitinib malate	12.5 mg, 25 mg, 37.5 mg and 50 mg	021938	1	2010-01-26

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Capsules

12.5 mg, 25 mg, 37.5 mg and 50 mg

2010-01-26

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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
Teva Pharms Usa	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213803-004	Nov 30, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218024-001	Oct 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218024-002	Oct 24, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218615-003	Mar 14, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213914-001	Aug 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	215843-001	Apr 11, 2022	AB	RX	No	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

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	175
Patent Applications:	2,379
Drug Prices:	Drug price trends for sunitinib malate
What excipients (inactive ingredients) are in sunitinib malate?	sunitinib malate excipients list
DailyMed Link:	sunitinib malate at DailyMed

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors