Question 1

Is there a generic for Regorafenib?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Regorafenib, referencing the brand STIVARGA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Regorafenib?

Accepted Answer

STIVARGA (NDA 203085, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Regorafenib?

Accepted Answer

The Orange Book lists 4 patents against Regorafenib products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Regorafenib are approved?

Accepted Answer

Regorafenib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8680124	Jun 02, 2030	in 4 yr	U-1506
8637553	Feb 16, 2031	in 4 yr 9 mo	SubstanceProduct
9458107	Apr 08, 2031	in 4 yr 10 mo	Product
9957232	Jul 09, 2032	in 6 yr 2 mo	Substance

Regorafenib

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Listed patents (4)

Regorafenib — frequently asked questions

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