FDA Orange Book

Generic for Zipsor

Zipsor contains diclofenac. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Zipsor is diclofenac. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Zipsor products in the Orange Book

Zipsor products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	25MG	Marketed (Rx)	AB	3	AB

NDA 022202, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic diclofenac

Approved generic versions of Zipsor
Company	ANDA	TE code	Approved	Strengths
BIONPHARMA INC	204648	AB (A-rated, therapeutically equivalent)	February 23, 2016	25MG
ONESOURCE SOFTGELS PTE LTD	210078	AB (A-rated, therapeutically equivalent)	December 3, 2019	25MG
AUROBINDO PHARMA LTD	213875	AB (A-rated, therapeutically equivalent)	October 19, 2021	25MG

Zipsor patents

Patents listed for Zipsor
Patent	Expires	Covers	Use code	NDA
7884095	February 24, 2029	Method of use	U-1111	022202
8110606	February 24, 2029	Method of use	U-980	022202
7662858	February 24, 2029	Method of use	U-1035	022202
7939518	February 24, 2029	Method of use	U-980	022202
8623920	February 24, 2029	Method of use	U-1482	022202
9561200	February 24, 2029	Method of use	U-1482	022202

Zipsor NDC codes

Questions

Is there a generic for Zipsor?

Yes. The generic name for Zipsor is diclofenac. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Zipsor?

The active ingredient in Zipsor is diclofenac, per the FDA Orange Book.

When does the Zipsor patent expire?

The last patent listed for Zipsor in the Orange Book expires February 24, 2029. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.