FDA Orange Book

Generic for Clindesse

Clindesse contains clindamycin. 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 Clindesse is clindamycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Clindesse products in the Orange Book

Clindesse products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
cream, vaginal	EQ 2% BASE	Marketed (Rx)	None	1	AB

NDA 050793, held by PADAGIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clindamycin

Approved generic versions of Clindesse
Company	ANDA	TE code	Approved	Strengths
FOUGERA PHARMACEUTICALS INC	065139	AB (A-rated, therapeutically equivalent)	December 27, 2004	EQ 2% BASE

Clindesse patents

Patents listed for Clindesse
Patent	Expires	Covers	Use code	NDA
9789057	December 2, 2026	Drug product	U-137	050793

Clindesse NDC codes

45802-042

Questions

Is there a generic for Clindesse?

Yes. The generic name for Clindesse is clindamycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Clindesse?

The active ingredient in Clindesse is clindamycin, per the FDA Orange Book.

When does the Clindesse patent expire?

The last patent listed for Clindesse in the Orange Book expires December 2, 2026. 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.