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FDA Orange Book · active-ingredient family

Bromocriptine mesylate

Bromocriptine mesylate is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYCLOSET · NDA 020866

2

Brand (NDA)

6

Generics (ANDA)

13

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
CYCLOSETRLDVEROSCIENCENDA 020866—May 05, 2009
PARLODELRLD×2ESJAY PHARMANDA 017962ABMar 01, 1982

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
BROMOCRIPTINE MESYLATEPADAGIS USANDA 077646ABOct 01, 2008
BROMOCRIPTINE MESYLATEZYDUS PHARMS USA INCANDA 078899ABJul 30, 2008
BROMOCRIPTINE MESYLATEMYLANANDA 077226ABApr 04, 2005
BROMOCRIPTINE MESYLATEAUROBINDO PHARMA USAANDA 076962—Sep 24, 2004
BROMOCRIPTINE MESYLATELEK PHARMANDA 075100—Dec 10, 1998
BROMOCRIPTINE MESYLATESANDOZANDA 074631ABJan 13, 1998

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8877708Jun 07, 2030in 4 yr
ProductU-1706
9352025Jun 07, 2030in 4 yr
U-2111
9895422Jun 07, 2030in 4 yr
U-2285
10688155Jun 07, 2030in 4 yr
U-2898
8431155Apr 30, 2032in 5 yr 11 mo
ProductU-976
9700555Apr 30, 2032in 5 yr 11 mo
ProductU-2190
9993474Apr 30, 2032in 5 yr 11 mo
U-2393
9192576Apr 30, 2032in 5 yr 11 mo
ProductU-976
9522117Apr 30, 2032in 5 yr 11 mo
ProductU-1939
10688094Apr 30, 2032in 5 yr 11 mo
U-2871
11000522Apr 30, 2032in 5 yr 11 mo
U-3119
8613947Apr 30, 2032in 5 yr 11 mo
ProductU-976
11666567Apr 30, 2032in 5 yr 11 mo
U-4015

Bromocriptine mesylate — 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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