Is there a generic for Enalaprilat?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Enalaprilat, referencing the brand VASOTEC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Enalaprilat?

VASOTEC (NDA 019309, BIOVAIL LABS INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Enalaprilat are approved?

Enalaprilat is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Enalaprilat

Enalaprilat is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VASOTEC · NDA 019309

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VASOTECRLD	BIOVAIL LABS INTL	NDA 019309	—	Feb 09, 1988

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
ENALAPRILAT	HIKMA FARMACEUTICA	ANDA 078687	AP	Dec 23, 2008
ENALAPRILAT	CHARTWELL INJECTABLE	ANDA 075634	AP	Aug 22, 2000
ENALAPRILAT	DR REDDYS	ANDA 075578	AP	Aug 22, 2000
ENALAPRILAT	HOSPIRA	ANDA 075456	—	Aug 22, 2000
ENALAPRILAT	HOSPIRA	ANDA 075458	—	Aug 22, 2000
ENALAPRILAT	HOSPIRA	ANDA 075571	—	Aug 22, 2000

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.

Enalaprilat — frequently asked questions

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

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