Is There a Generic for Xaciato?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Xaciato (clindamycin). The Orange Book shows its last listed patent expires September 22, 2036 and its last listed exclusivity ends December 7, 2029.

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Xaciato products in the Orange Book

Xaciato products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, vaginal	EQ 2% BASE	Marketed (Rx)	None	0	None

NDA 215650, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Xaciato patents

Patents listed for Xaciato
Patent	Expires	Covers	Use code	NDA
11129896	September 22, 2036	Method of use	U-3293	215650
12303563	September 22, 2036	Drug product	None	215650

Xaciato exclusivity

Exclusivity listed for Xaciato
Code	Meaning	Expires	NDA
NP	New product	December 7, 2024	215650
GAIN	Generating Antibiotic Incentives Now	December 7, 2029	215650

Xaciato NDC codes

78206-189

Questions

Is there a generic for Xaciato?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Xaciato (clindamycin). The Orange Book shows its last listed patent expires September 22, 2036 and its last listed exclusivity ends December 7, 2029.

What is the generic name for Xaciato?

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

When does the Xaciato patent expire?

The last patent listed for Xaciato in the Orange Book expires September 22, 2036. 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.