Assyro AI

FDA Orange Book · active-ingredient family

Clozapine

Clozapine is approved as 3 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VERSACLOZ · NDA 203479

3

Brand (NDA)

13

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
VERSACLOZRLDDOUGLAS PHARMSNDA 203479—Feb 06, 2013
FAZACLO ODTRLD×6JAZZNDA 021590—May 30, 2007
CLOZARILRLD×4HERITAGE LIFENDA 019758ABSep 26, 1989

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
CLOZAPINE×5AUROBINDO PHARMAANDA 212923ABDec 12, 2024
CLOZAPINE×5BARR LABS INCANDA 090308ABApr 09, 2018
CLOZAPINE×4ZYDUS PHARMSANDA 209480—Dec 06, 2017
CLOZAPINE×4AUROBINDO PHARMAANDA 206433ABNov 29, 2016
CLOZAPINE×2ACCORD HLTHCAREANDA 202873ABNov 25, 2015
CLOZAPINE×4DR REDDYS LABS SAANDA 203807—Sep 17, 2015
CLOZAPINE×4MYLANANDA 201824ABSep 15, 2015
CLOZAPINE×5MYLANANDA 075417—Apr 15, 2010
CLOZAPINE×3IVAX SUB TEVA PHARMSANDA 076809ABDec 16, 2005
CLOZAPINE×2PAR PHARMANDA 075162—Apr 26, 2005
CLOZAPINE×4IVAX SUB TEVA PHARMSANDA 074949—Jul 31, 2003
CLOZAPINE×4SUN PHARM INDS INCANDA 075713—Nov 15, 2002
CLOZAPINE×2SANDOZANDA 074546—Aug 30, 1996

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8057811May 01, 2028in 1 yr 11 mo
Product

Clozapine — 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.

Book a Demo