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FDA Orange Book · active-ingredient family

Mipomersen sodium

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

Reference-listed drug:KYNAMRO · NDA 203568

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
KYNAMRORLDKASTLE THERAPS LLCNDA 203568—Jan 29, 2013

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7511131Jan 29, 2027in 7 mo
Substance

Mipomersen 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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