Assyro AI

FDA Orange Book · active-ingredient family

Fentanyl

Fentanyl is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SUBSYS · NDA 202788

2

Brand (NDA)

9

Generics (ANDA)

10

Listed patents

0

Exclusivity periods

Brand (NDA) products · film, extended release, spray

ProductApplicantApplicationTEApproved
SUBSYSRLD×7BTCP PHARMANDA 202788—Jan 04, 2012
DURAGESIC-100RLD×6JANSSEN PHARMSNDA 019813—Aug 07, 1990

Generic (ANDA) products (9)

ProductApplicantApplicationTEApproved
FENTANYL-100×8ZYDUS PHARMSANDA 209655—Jan 24, 2023
FENTANYL-100×5KINDEVAANDA 202097ABNov 04, 2016
FENTANYL-100×7SPECGX LLCANDA 077154ABFeb 09, 2011
FENTANYL-100×4NOVENANDA 077775—Oct 16, 2009
FENTANYL-100×8DIFGEN PHARMSANDA 077449ABOct 20, 2008
FENTANYL-100×4ACTAVIS LABS UT INCANDA 076709—Aug 20, 2007
FENTANYL-100×4MAYNE PHARMAANDA 077062—Aug 20, 2007
FENTANYL-100×4LAVIPHARM LABSANDA 077051—Aug 04, 2006
FENTANYL-100×8MYLAN TECHNOLOGIESANDA 076258ABJan 28, 2005

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9642797Jan 25, 2027in 7 mo
ProductU-55
8835460Jan 25, 2027in 7 mo
ProductU-55
9289387Jan 25, 2027in 7 mo
ProductU-55
9241935Jan 25, 2027in 7 mo
Product
10016403Jan 25, 2027in 7 mo
Product
8835459Jan 25, 2027in 7 mo
Product
10610523Jan 25, 2027in 7 mo
Product
9642844Jan 25, 2027in 7 mo
Product
8486973Apr 27, 2030in 3 yr 11 mo
U-55
8486972Apr 27, 2030in 3 yr 11 mo
Product

Fentanyl — 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