FDA Orange Book · active-ingredient family

Naproxen sodium

Naproxen sodium: 4 brands, 39 generics; first approved Sep 30, 1987; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 39 ANDA applications approved.

Earliest patent expiry Mar 03, 2026

Brands (NDA)

4

Generics (ANDA)

39

Listed patents

5

Next patent expiry

Mar 03, 2026

4 mo ago

Originator applications

Brand (NDA) products

NAPROXEN SODIUMRLDRS

BIONPHARMANDA 0219202006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	OTC	—

TWI PHARMSNDA 02035319963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 375MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 500MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 750MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

ALEVERLDRS

BAYERNDA 0202041994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

ATNAHS PHARMA USNDA 018164—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (39)

NAPROXEN SODIUM

PATHEON SOFTGELSANDA 2144632023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	OTC	—

NAPROXEN SODIUM

HETERO LABS LTD VANDA 2110652022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

ONESOURCE SPECIALTYANDA 2154722022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	Discontinued	—

NAPROXEN SODIUM

SCIEGEN PHARMSANDA 21219920192 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

NAPROXEN SODIUM

YICHANG HUMANWELLANDA 2120332019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

CATALENTANDA 2028072019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	OTC	—

NAPROXEN SODIUM

NOVELGENIX THERAPSANDA 2076122018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

PURACAP PHARM LLCANDA 2083632018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE	CAPSULE	ORAL	OTC	—

NAPROXEN SODIUM

LNK INTL INCANDA 2048722017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

AUROBINDO PHARMA LTDANDA 2054972016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

AUROBINDO PHARMA LTDANDA 20062920112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

NAPROXEN SODIUM

GRANULES INDIAANDA 0913532011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

SUN PHARM INDS LTDANDA 0911832011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

MARKSANS PHARMAANDA 0905452011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

AMNEAL PHARMS NYANDA 0790962008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

DR REDDYS LABS LTDANDA 07848620072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

NAPROXEN SODIUM

GLENMARK PHARMS LTDANDA 07831420072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

NAPROXEN SODIUM

AMNEAL PHARMS NYANDA 07843220072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

ABLEANDA 07654420032 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

ACTAVIS LABS FL INCANDA 07541620033 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 375MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
EQ 750MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

NAPROXEN SODIUM

DR REDDYS LABS INCANDA 0751681998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

HIKMAANDA 07448019982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	TABLET	ORAL	Discontinued	—
EQ 250MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

CONTRACT PHARMACALANDA 0747891997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

CONTRACT PHARMACALANDA 0746351997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

PERRIGOANDA 0746611997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	OTC	—

NAPROXEN SODIUM

PLD ACQUISITIONS LLCANDA 0746461997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
220MG	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

PLIVAANDA 07424219962 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

WATSON LABSANDA 07445519952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

PUREPAC PHARMANDA 07431919952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

IVAX SUB TEVA PHARMSANDA 07423019952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

SANDOZANDA 07449519942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

PHARMOBEDIENTANDA 07436719942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

TEVA PHARMSANDA 07428919942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

ROXANEANDA 07425719932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

SANDOZANDA 07416219932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

TEVAANDA 07414219932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

TEVAANDA 07419819932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

WATSON LABSANDA 07419519932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

NAPROXEN SODIUM

HAMILTON PHARMSANDA 07410619932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10028925	Mar 03, 2026	4 mo ago	ProductU-1731
10022344	Mar 03, 2026	4 mo ago	ProductU-1731
11090280	Mar 03, 2026	4 mo ago	ProductU-1731
9693979	Mar 03, 2026	4 mo ago	Product
9693978	Mar 03, 2026	4 mo ago	Product

FDA approval span

Approval history

First approval

Sep 30, 1987

39 yr 4 mo ago

Most recent approval

Jan 10, 2023

3 yr 7 mo ago

Approvals span 1987–2023 across 43 FDA applications.

Brand (NDA) 49%

Generic (ANDA) 3991%

Naproxen sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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