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FDA Orange Book · active-ingredient family

Methylnaltrexone bromide

Methylnaltrexone bromide: 2 brands, 2 generics; first approved Apr 24, 2008; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
2
Listed patents
12
Next patent expiry
Aug 03, 2027
in 9 mo

Brand (NDA) products

Originator applications
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  • RELISTORRLDRS
    NDA 2082712016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    150MGTABLETORALRx-
  • RELISTORRLDRS
    NDA 02196420103 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    12MG/0.6ML (12MG/0.6ML)SOLUTIONSUBCUTANEOUSRx-
    8MG/0.4ML (8MG/0.4ML)SOLUTIONSUBCUTANEOUSRx-
    12MG/0.6ML (12MG/0.6ML)SOLUTIONSUBCUTANEOUSRx-

Generic (ANDA) products (2)

Abbreviated applications
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  • METHYLNALTREXONE BROMIDE
    ANDA 2085922025
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    12MG/0.6ML (12MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued-
  • METHYLNALTREXONE BROMIDE
    ANDA 20811220242 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    8MG/0.4ML (8MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    12MG/0.6ML (12MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued-

Patent & exclusivity timeline

Protection horizon
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2026202720282029203020312032TodayPatent 12303592: 2027-08-03Patent 12303592Patent 8420663: 2029-09-30Patent 8420663Patent 8822490: 2029-09-30Patent 8822490Patent 9180125: 2029-09-30Patent 9180125Patent 9492445: 2029-09-30Patent 9492445Patent 9724343: 2029-09-30Patent 9724343Patent 8247425: 2030-12-31Patent 8247425Patent 8956651: 2031-03-10Patent 8956651Patent 9314461: 2031-03-10Patent 9314461Patent 10376505: 2031-03-10Patent 10376505Patent 8524276: 2031-03-10Patent 8524276Patent 10307417: 2031-03-10Patent 10307417
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
12303592in 9 mo
ProductU-4197
8420663in 3 yr
U-1185
8822490in 3 yr
ProductU-1185
9180125in 3 yr
ProductU-1185
9492445in 3 yr
ProductU-1185
9724343in 3 yr
ProductU-1185
8247425in 4 yr 3 mo
U-1185
8956651in 4 yr 5 mo
Product
9314461in 4 yr 5 mo
Product
10376505in 4 yr 5 mo
Product
8524276in 4 yr 5 mo
Product
10307417in 4 yr 5 mo
Product

Approval history

FDA approval span
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First approval
18 yr 9 mo ago
Most recent approval
1 yr 5 mo ago

Approvals span 2008–2025 across 4 FDA applications.

Brand (NDA) 250%
Generic (ANDA) 250%

Methylnaltrexone bromide: 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.

Related FDA reference tools

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