Is there a generic for Misoprostol?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Misoprostol, referencing the brand CYTOTEC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Misoprostol?

CYTOTEC (NDA 019268, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Misoprostol are approved?

Misoprostol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Misoprostol

Misoprostol is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYTOTEC · NDA 019268

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
CYTOTECRLD×2	PFIZER	NDA 019268	AB	Sep 21, 1990

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
MISOPROSTOL×2	MICRO LABS	ANDA 216872	AB	Oct 17, 2022
MISOPROSTOL×2	ACQ PHARMA	ANDA 210201	AB	Jul 02, 2019
MISOPROSTOL×2	NOVEL LABS INC	ANDA 091667	—	Jul 25, 2012
MISOPROSTOL×2	ANI PHARMS	ANDA 076095	AB	Jul 10, 2002

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Misoprostol — frequently asked questions

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

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