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FDA Orange Book · active-ingredient family

Glimepiride

Glimepiride is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMARYL · NDA 020496

1

Brand (NDA)

17

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
AMARYLRLD×3SANOFI AVENTIS USNDA 020496—Nov 30, 1995

Generic (ANDA) products (17)

ProductApplicantApplicationTEApproved
GLIMEPIRIDE×3HIKMA PHARMSANDA 078952—Aug 01, 2013
GLIMEPIRIDE×3REGCON HOLDINGSANDA 202112ABApr 17, 2013
GLIMEPIRIDE×3AUROBINDO PHARMA LTDANDA 202759ABJun 29, 2012
GLIMEPIRIDE×6MICRO LABSANDA 091220ABJun 29, 2012
GLIMEPIRIDE×3ACTAVIS LABS FL INCANDA 076995—Apr 27, 2010
GLIMEPIRIDE×3CARLSBADANDA 077911ABSep 22, 2009
GLIMEPIRIDE×3ACCORD HLTHCAREANDA 078181ABAug 23, 2007
GLIMEPIRIDE×3MYLANANDA 077486—Feb 10, 2006
GLIMEPIRIDE×3WATSON LABSANDA 077280—Feb 03, 2006
GLIMEPIRIDE×4PRINSTON INCANDA 077370ABDec 23, 2005
GLIMEPIRIDE×3QUAGENANDA 077624—Nov 28, 2005
GLIMEPIRIDE×3CHARTWELL MOLECULARANDA 077295ABOct 06, 2005
GLIMEPIRIDE×3DR REDDYS LABS LTDANDA 077091ABOct 06, 2005
GLIMEPIRIDE×3EPIC PHARMA LLCANDA 077274—Oct 06, 2005
GLIMEPIRIDE×2RANBAXYANDA 077366—Oct 06, 2005
GLIMEPIRIDE×4RANBAXY LABS LTDANDA 076875—Oct 06, 2005
GLIMEPIRIDE×3SENORES PHARMSANDA 076802—Oct 06, 2005

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.

Glimepiride — frequently asked questions

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

Agent CTA Background

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