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FDA Orange Book · active-ingredient family

Mipomersen sodium

Mipomersen sodium: 1 brand, 0 generics; first approved Jan 29, 2013; on patent until Jan 29, 2027.

On patentHas discontinued products
Generic status & protection

Protected until Jan 29, 2027 (earliest listed patent expiry).

Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
1
Next patent expiry
Jan 29, 2027
in 3 mo

Brand (NDA) products

Originator applications
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  • KYNAMRORLD
    NDA 2035682013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    200MG/ML (200MG/ML)SOLUTIONSUBCUTANEOUSDiscontinued-

Patent & exclusivity timeline

Protection horizon
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202620272028TodayPatent 7511131: 2027-01-29Patent 7511131
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7511131in 3 mo
Substance

Approval history

FDA approval span
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First approval
13 yr 11 mo ago
Most recent approval
13 yr 11 mo ago

All 1 application were approved in 2013.

Brand (NDA) 1100%
Generic (ANDA) 00%

Mipomersen sodium: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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