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FDA Orange Book · active-ingredient family

Defibrotide sodium

Defibrotide sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DEFITELIO · NDA 208114

1

Brand (NDA)

0

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
DEFITELIORLDJAZZ PHARMS INCNDA 208114—Mar 30, 2016

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11236328Jun 22, 2032in 6 yr 1 mo
U-3301
11085043Jun 22, 2032in 6 yr 1 mo
Product
12529052Jun 22, 2032in 6 yr 1 mo
Product
11746348Jun 22, 2032in 6 yr 1 mo
Product
12534722Jun 22, 2032in 6 yr 1 mo
Product

Defibrotide sodium — 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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