Is there a generic for Diclofenac sodium?

Yes. The FDA Orange Book lists 57 approved generic (ANDA) applications for Diclofenac sodium, referencing the brand DYLOJECT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diclofenac sodium?

DYLOJECT (NDA 022396, JAVELIN PHARMS INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Diclofenac sodium?

The Orange Book lists 20 patents against Diclofenac sodium products, with the earliest listed expiry in 2027. 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.

What dosage forms of Diclofenac sodium are approved?

Diclofenac sodium is approved in the following dosage forms: gel, solution, solution/drops, tablet, delayed release, tablet, extended release.

FDA Orange Book · active-ingredient family

Diclofenac sodium

Diclofenac sodium: 9 brands, 57 generics; first approved Jul 28, 1988; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 57 ANDA applications approved.

Earliest patent expiry Mar 22, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 22, 2027

in 7 mo

Brand (NDA) products

Originator applications

DYLOJECTRLD
JAVELIN PHARMS INCNDA 0223962014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
37.5MG/ML (37.5MG/ML) SOLUTION INTRAVENOUS Discontinued —
PENNSAIDRLD
HORIZONNDA 2046232014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued —
PENNSAIDRLD
NUVO PHARMS INCNDA 0209472009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Discontinued —
VOLTAREN ARTHRITIS PAINRLDRS
HALEON US HOLDINGSNDA 0221222007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
SOLARAZERLD
FOUGERA PHARMSNDA 0210052000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Discontinued —
VOLTAREN-XRRLD
NOVARTISNDA 0202541996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Discontinued —
VOLTARENRLD
NOVARTISNDA 0200371991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
37.5MG/ML (37.5MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

VOLTARENRLD

NOVARTISNDA 01920119883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
50MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
75MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

DICLOFENAC SODIUM
FALCON PHARMSNDA 0208091998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Generic (ANDA) products (57)

Abbreviated applications

DICLOFENAC SODIUM
UMEDICAANDA 21994520253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, DELAYED RELEASE ORAL Rx AB
50MG TABLET, DELAYED RELEASE ORAL Rx AB
75MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
ENCUBEANDA 2176462025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
RUBICON RESEARCHANDA 21654820233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, DELAYED RELEASE ORAL Rx AB
50MG TABLET, DELAYED RELEASE ORAL Rx AB
75MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
AUROLIFE PHARMA LLCANDA 2130402023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
ALEMBICANDA 2125062022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
SUN PHARMA CANADAANDA 2080982022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
INGENUS PHARMS LLCANDA 2162752022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Rx AB
DICLOFENAC SODIUMRS
LUPIN PHARMSANDA 2080212022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
AMNEALANDA 2081982022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
ALEMBICANDA 2123512022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Rx AB
DICLOFENAC SODIUM
APOTEXANDA 2077142022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Rx AB
DICLOFENAC SODIUM
EPIC PHARMA LLCANDA 2066552021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
ENCUBEANDA 2109862020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
DICLOFENAC SODIUM
RISINGANDA 2087862019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
37.5MG/ML (37.5MG/ML) SOLUTION INTRAVENOUS Discontinued —
DICLOFENAC SODIUM
PERRIGO PHARMA INTLANDA 2112532019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
DICLOFENAC SODIUM
AUROLIFE PHARMA LLCANDA 2043062019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
DICLOFENAC SODIUM
HIKMAANDA 2094842018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL Discontinued —
DICLOFENAC SODIUM
CIPLAANDA 2099032018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
DICLOFENAC SODIUM
PADAGIS ISRAELANDA 2108932018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Rx AB
DICLOFENAC SODIUM
ZYDUS LIFESCIENCESANDA 2064112018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
RISINGANDA 2067152017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Discontinued —
DICLOFENAC SODIUM
GLENMARK PHARMS LTDANDA 2083012016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Rx AB
DICLOFENAC SODIUM
AMNEAL PHARMSANDA 2061162016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUMRS
SUN PHARMA CANADAANDA 2062982016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Rx AB
DICLOFENAC SODIUM
AMNEAL PHARMSANDA 2080772016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% GEL TOPICAL OTC —
DICLOFENAC SODIUM
NOVEL LABS INCANDA 2058782015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
ACTAVIS MID ATLANTICANDA 2064932015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Rx AB
DICLOFENAC SODIUM
ALTAIRE PHARMS INCANDA 2033832015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AT
DICLOFENAC SODIUM
LUPINANDA 2041322015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
PAI HOLDINGS PHARMANDA 2027692015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Discontinued —
DICLOFENAC SODIUMRS
SUN PHARMA CANADAANDA 2038182014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
TWI PHARMSANDA 2023932014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Discontinued —
DICLOFENAC SODIUM
WATSON LABS INCANDA 2028522014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Rx AT
DICLOFENAC SODIUM
APOTEXANDA 2020272014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% SOLUTION TOPICAL Discontinued —
DICLOFENAC SODIUM
AMNEALANDA 2009362013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3% GEL TOPICAL Discontinued —
DICLOFENAC SODIUMRS
UNIQUEANDA 09006620102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, DELAYED RELEASE ORAL Rx AB
50MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
RUBICON RESEARCHANDA 0776002008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AT
DICLOFENAC SODIUM
SCIEGEN PHARMSANDA 0778452008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —
DICLOFENAC SODIUM
SANDOZANDA 0780312008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AT
DICLOFENAC SODIUMRS
BAUSCH AND LOMBANDA 0787922007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AT
DICLOFENAC SODIUM
RISINGANDA 0785532007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AT
DICLOFENAC SODIUMRS
UNIQUEANDA 0778632007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUMRS
DEXCEL LTDANDA 0762012002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
AUROBINDO PHARMA USAANDA 07528120022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, DELAYED RELEASE ORAL Rx AB
75MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
ACTAVIS ELIZABETHANDA 0759102002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
AUROBINDO PHARMA USAANDA 0761522001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
VPNAANDA 0754922000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET, EXTENDED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
PLIVAANDA 07443219992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, DELAYED RELEASE ORAL Discontinued —
75MG TABLET, DELAYED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
TEVAANDA 0747231999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, DELAYED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
MICRO LABSANDA 07498619992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, DELAYED RELEASE ORAL Discontinued —
75MG TABLET, DELAYED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
CARLSBADANDA 07518519983 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG TABLET, DELAYED RELEASE ORAL Rx AB
25MG TABLET, DELAYED RELEASE ORAL Rx AB
50MG TABLET, DELAYED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
50MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
75MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
50MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
75MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
37.5MG/ML (37.5MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	GEL	TOPICAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB
50MG	TABLET, DELAYED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

DICLOFENAC SODIUM

TEVA PHARMSANDA 07445919973 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
50MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
75MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

DICLOFENAC SODIUM
TEVAANDA 0743901996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG TABLET, DELAYED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
ACTAVIS ELIZABETHANDA 07451419962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG TABLET, DELAYED RELEASE ORAL Rx AB
75MG TABLET, DELAYED RELEASE ORAL Rx AB
DICLOFENAC SODIUM
CHARTWELL RXANDA 0743941995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG TABLET, DELAYED RELEASE ORAL Discontinued —
DICLOFENAC SODIUM
CHARTWELL RXANDA 07437619952 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET, DELAYED RELEASE ORAL Discontinued —
50MG TABLET, DELAYED RELEASE ORAL Discontinued —

DICLOFENAC SODIUM

ROXANEANDA 07439119953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
50MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—
75MG	TABLET, DELAYED RELEASE	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8946292	Mar 22, 2027	in 7 mo	U-1659
9132110	Oct 17, 2027	in 1 yr 2 mo	U-1488
9168305	Oct 17, 2027	in 1 yr 2 mo	U-1488
9066913	Oct 17, 2027	in 1 yr 2 mo	ProductU-1488
9339551	Oct 17, 2027	in 1 yr 2 mo	U-1488
9220784	Oct 17, 2027	in 1 yr 2 mo	U-1488
9339552	Oct 17, 2027	in 1 yr 2 mo	ProductU-1488
9539335	Oct 17, 2027	in 1 yr 2 mo	U-1614
8563613	Oct 17, 2027	in 1 yr 2 mo	ProductU-1488
8871809	Oct 17, 2027	in 1 yr 2 mo	U-1614
9101591	Oct 17, 2027	in 1 yr 2 mo	ProductU-1488
9168304	Oct 17, 2027	in 1 yr 2 mo	Product
8252838	Apr 21, 2028	in 1 yr 8 mo	ProductU-1489
8741956	Jul 10, 2029	in 2 yr 11 mo	U-1435
8618164	Jul 10, 2029	in 2 yr 11 mo	U-1477
9370501	Jul 10, 2029	in 2 yr 11 mo	U-1614
8217078	Jul 10, 2029	in 2 yr 11 mo	U-1477
9375412	Jul 10, 2029	in 2 yr 11 mo	U-1614
9415029	Jul 10, 2029	in 2 yr 11 mo	U-1614
8546450	Aug 09, 2030	in 4 yr	U-1435

Approval history

FDA approval span

First approval

Jul 28, 1988

38 yr 8 mo ago

Most recent approval

Nov 05, 2025

10 mo ago

Approvals span 1988–2025 across 66 FDA applications.

Brand (NDA) 914%

Generic (ANDA) 5786%

Diclofenac 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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