Sunitinib malate - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for sunitinib malate and what is the scope of freedom to operate?

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

There are seven drug master file entries for sunitinib malate. Eight 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

Subscribe to access the full database, or 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
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-001	Jan 26, 2006	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novugen	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218012-003	Aug 21, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213914-001	Aug 16, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218024-003	Oct 24, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213914-003	Aug 16, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218024-004	Oct 24, 2023	AB	RX	No	No	⤷ 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

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	175
Patent Applications:	2,950
Formulation / Manufacturing:	see details
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