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FDA Orange Book · active-ingredient family

Calcipotriene

Calcipotriene is approved as 4 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SORILUX · NDA 022563

4

Brand (NDA)

8

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, ointment, solution

ProductApplicantApplicationTEApproved
SORILUXRLDMAYNE PHARMANDA 022563—Oct 06, 2010
DOVONEXRLDLEO PHARMNDA 020611—Mar 03, 1997
DOVONEXRLDLEO PHARMA ASNDA 020554ABJul 22, 1996
DOVONEXRLDLEO PHARMA ASNDA 020273ABDec 29, 1993

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
CALCIPOTRIENECHARTWELL RXANDA 207163ATDec 26, 2017
CALCIPOTRIENEGLENMARK SPECLTANDA 205772ABJun 09, 2015
CALCIPOTRIENECHARTWELL RXANDA 200935—May 30, 2012
CALCIPOTRIENECOSETTE PHARMS NCANDA 078468ATMar 24, 2011
CALCIPOTRIENEGLENMARK PHARMSANDA 090633ABMar 24, 2010
CALCIPOTRIENECHARTWELL RXANDA 077029—Nov 20, 2009
CALCIPOTRIENEHIKMAANDA 077579—Nov 19, 2009
CALCIPOTRIENEFOUGERA PHARMSANDA 078305ATMay 06, 2008

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8629128May 26, 202624 d ago
ProductU-1280
8263580May 07, 2028in 1 yr 11 mo
ProductU-1280

Calcipotriene — 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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