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FDA Orange Book · active-ingredient family

Deferoxamine mesylate

Deferoxamine mesylate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DESFERAL · NDA 016267

1

Brand (NDA)

5

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
DESFERALRLD×2MITEM PHARMANDA 016267May 25, 2000

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
DEFEROXAMINE MESYLATE×2GLANDANDA 207384APSep 29, 2017
DEFEROXAMINE MESYLATE×2FRESENIUS KABI USAANDA 078718APSep 15, 2009
DEFEROXAMINE MESYLATE×2HIKMAANDA 078086May 30, 2007
DEFEROXAMINE MESYLATE×2DR REDDYSANDA 076806Mar 31, 2006
DEFEROXAMINE MESYLATE×2HOSPIRAANDA 076019APMar 17, 2004

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.

Deferoxamine mesylate — 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.