Assyro AI

FDA Orange Book · active-ingredient family

Moexipril hydrochloride

Moexipril hydrochloride 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:UNIVASC · NDA 020312

1

Brand (NDA)

4

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
UNIVASC×2UCB INCNDA 020312Apr 19, 1995

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
MOEXIPRIL HYDROCHLORIDE×2GLENMARK PHARMS LTDANDA 090416ABMar 30, 2010
MOEXIPRIL HYDROCHLORIDE×2APOTEX INCANDA 078454Jun 02, 2008
MOEXIPRIL HYDROCHLORIDE×2CHARTWELL RXANDA 077536ABNov 30, 2006
MOEXIPRIL HYDROCHLORIDE×2TEVAANDA 076204ABMay 08, 2003

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.

Moexipril hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.