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FDA Orange Book · active-ingredient family

Ramipril

Ramipril is approved as 3 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VOSTALLY · NDA 219757

3

Brand (NDA)

17

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
VOSTALLYRLDROSEMONT PHARMSNDA 219757Jul 23, 2025
ALTACERLD×4KING PFIZERNDA 022021Feb 27, 2007
ALTACERLD×4KING PHARMS LLCNDA 019901Jan 28, 1991

Generic (ANDA) products (17)

ProductApplicantApplicationTEApproved
RAMIPRIL×4APOTEXANDA 091069Dec 02, 2015
RAMIPRIL×4ACCORD HLTHCAREANDA 202392Apr 15, 2014
RAMIPRIL×4NATCO PHARMAANDA 090650Jun 30, 2011
RAMIPRIL×4AUROBINDO PHARMA LTDANDA 091604ABJun 08, 2011
RAMIPRIL×4ZYDUS PHARMS USA INCANDA 090697Sep 24, 2009
RAMIPRIL×2RANBAXY LABS LTDANDA 078849Mar 06, 2009
RAMIPRIL×4ZYDUS PHARMS USAANDA 078832ABSep 02, 2008
RAMIPRIL×4CIPLAANDA 077004Aug 07, 2008
RAMIPRIL×4COREPHARMAANDA 079116ABJun 20, 2008
RAMIPRIL×4ACTAVIS ELIZABETHANDA 077513Jun 18, 2008
RAMIPRIL×4CHARTWELL MOLECULARANDA 078745ABJun 18, 2008
RAMIPRIL×4CHARTWELL RXANDA 077514Jun 18, 2008
RAMIPRIL×4HIKMAANDA 077900ABJun 18, 2008
RAMIPRIL×4SENORES PHARMSANDA 078191ABJun 18, 2008
RAMIPRIL×4TEVA PHARMSANDA 077470Jun 18, 2008
RAMIPRIL×4LUPINANDA 077626ABJun 09, 2008
RAMIPRIL×4WATSON LABSANDA 076549ABOct 24, 2005

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12343338Aug 16, 2039in 13 yr 4 mo
ProductU-4233

Ramipril — 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.