Question 1

Is there a generic for Naproxen sodium; sumatriptan succinate?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Naproxen sodium; sumatriptan succinate, referencing the brand TREXIMET. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Naproxen sodium; sumatriptan succinate?

Accepted Answer

TREXIMET (NDA 021926, CURRAX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Naproxen sodium; sumatriptan succinate?

Accepted Answer

The Orange Book lists 2 patents against Naproxen sodium; sumatriptan succinate products, with the earliest listed expiry in 2025. 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 Naproxen sodium; sumatriptan succinate are approved?

Accepted Answer

Naproxen sodium; sumatriptan succinate is approved in the following dosage form: tablet.

Product	Applicant	Application	TE	Approved
SUMATRIPTAN AND NAPROXEN SODIUM	RISING	ANDA 090872	AB	Sep 04, 2018
SUMATRIPTAN AND NAPROXEN SODIUM	SUN PHARM	ANDA 202803	AB	Jul 20, 2018
SUMATRIPTAN AND NAPROXEN SODIUM	AUROBINDO PHARMA LTD	ANDA 207457	AB	Feb 15, 2018

Patent	Expires	In	Type
7332183	Oct 02, 2025	9 mo ago	ProductU-1719
7332183*PED	Apr 02, 2026	3 mo ago

Naproxen sodium; sumatriptan succinate

Brand (NDA) products · tablet

Generic (ANDA) products (3)

Listed patents (2)

Naproxen sodium; sumatriptan succinate — frequently asked questions

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