Details for New Drug Application (NDA): 203085

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NDA 203085 describes STIVARGA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STIVARGA profile page.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Summary for 203085

Tradename:	STIVARGA
Applicant:	Bayer Hlthcare
Ingredient:	regorafenib
Patents:	4

Pharmacology for NDA: 203085

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Kinase Inhibitors UGT1A1 Inhibitors UGT1A9 Inhibitors

Suppliers and Packaging for NDA: 203085

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
STIVARGA	regorafenib	TABLET;ORAL	203085	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-171	50419-171-00	210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE
STIVARGA	regorafenib	TABLET;ORAL	203085	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-171	50419-171-03	3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Sep 27, 2012	TE:		RLD:	Yes
Patent:	8,637,553	Patent Expiration:	Feb 16, 2031	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,680,124	Patent Expiration:	Jun 2, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST), INCLUDING BUT NOT LIMITED TO PATIENTS PREVIOUSLY TREATED WITH IMATINIB AND PATIENTS WITH GIST HAVING RESISTANCE TO A KIT TYROSINE KINASE INHIBITOR
Patent:	9,458,107	Patent Expiration:	Apr 8, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203085

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012	7,351,834	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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