FDA Orange Book · active-ingredient family
Milnacipran hydrochloride
Milnacipran hydrochloride: 1 brand, 3 generics; first approved Jan 14, 2009; generic available.
Generic available
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
1
Next patent expiry
Sep 19, 2029
in 2 yr 11 mo
Brand (NDA) products
Originator applications
- SAVELLARLDABBVIENDA 02225620094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- MILNACIPRAN HYDROCHLORIDEHETERO LABS LTD VANDA 20514720244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - MILNACIPRAN HYDROCHLORIDEAMNEAL PHARMSANDA 20508120164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - MILNACIPRAN HYDROCHLORIDEBRECKENRIDGEANDA 20507120164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7994220 | in 2 yr 11 mo | U-819 |
Approval history
FDA approval span
First approval
18 yr ago
Most recent approval
2 yr 1 mo ago
Approvals span 2009–2024 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Milnacipran hydrochloride: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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