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 five 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:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203085

Generic Entry Date for 203085^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Pharmacology for NDA: 203085

Mechanism of Action	Cytochrome P450 2C9 Inhibitors Protein Kinase 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
Regulatory Exclusivity Expiration:	Apr 27, 2024
Regulatory Exclusivity Use:	TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC OR LIVER CANCER) WHO HAVE BEEN PREVIOUSLY TREATED WITH THE DRUG SORAFENIB.
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 28, 2022	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 16, 2031	Product Flag?	Y	Substance Flag?	Y	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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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