FDA Orange Book · active-ingredient family
Baclofen
Baclofen: 7 brands, 42 generics; first approved Jan 20, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 42 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
42
Listed patents
8
Next patent expiry
Sep 08, 2037
in 11 yr 3 mo
Brand (NDA) products
Originator applications
- AZURITYNDA 2156022022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML SUSPENSION ORAL Rx AB - LYVISPAHRLDSTRIDES PHARMA INTLNDA 21542220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/PACKET GRANULE ORAL Discontinued — 10MG/PACKET GRANULE ORAL Discontinued — 20MG/PACKET GRANULE ORAL Discontinued — - OZOBAXRLDMETACEL PHARMS LLCNDA 20819320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 10MG/5ML SOLUTION ORAL Rx AA - PIRAMAL CRITICALNDA 02246220104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML INJECTABLE INTRATHECAL Rx AP 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP 1MG/ML INJECTABLE INTRATHECAL Rx AP - KEMSTRORLDUCB INCNDA 02158920032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 20MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - AMNEALNDA 02007519963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP 0.05MG/ML INJECTABLE INTRATHECAL Rx AP - LIORESALRLDNOVARTISNDA 017851—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued —
Generic (ANDA) products (42)
Abbreviated applications
- BACLOFENAUROBINDO PHARMA LTDANDA 21409920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENSOMERSET THERAPS LLCANDA 09033420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 5MG TABLET ORAL Rx AB - BACLOFENRUBICON RESEARCHANDA 21444520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx — 10MG/5ML SOLUTION ORAL Rx AA - BACLOFENRISINGANDA 21778820243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENMICRO LABSANDA 21768720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - BACLOFENREGCON HOLDINGSANDA 21411420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENHERITAGEANDA 21630920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INTRATHECAL Discontinued — 2MG/ML INJECTABLE INTRATHECAL Discontinued — - BACLOFENANI PHARMSANDA 2172522023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/5ML SUSPENSION ORAL Rx AB - BACLOFENUNICHEMANDA 21206720233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENRUBICON RESEARCHANDA 21732420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 1MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENMANKIND PHARMAANDA 21588520223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - BACLOFENHIBROW HLTHCAREANDA 21155520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENLANNETT CO INCANDA 07724120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENIMPAXANDA 07797120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — - BACLOFENANDAS 5 HOLDINGANDA 21237820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB - BACLOFENRISINGANDA 21437420213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - BACLOFENMAIA PHARMS INCANDA 2107772021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENZYDUS LIFESCIENCESANDA 21165920204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - BACLOFENMAIA PHARMS INCANDA 21004820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENMAIA PHARMS INCANDA 2103152019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENPHARMOBEDIENTANDA 20959220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENPHARMOBEDIENTANDA 2095942018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENRUBICON RESEARCHANDA 20910220174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB - BACLOFENAMNEALANDA 09119320163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML INJECTABLE INTRATHECAL Rx AP 0.5MG/ML INJECTABLE INTRATHECAL Rx AP 2MG/ML INJECTABLE INTRATHECAL Rx AP - BACLOFENNORTHSTAR HLTHCAREANDA 07840120092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BACLOFENOXFORD PHARMSANDA 07708820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BACLOFENSUN PHARM INDS INCANDA 07786220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - BACLOFENPH HEALTHANDA 07706820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - BACLOFENPHARMOBEDIENTANDA 0771812005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BACLOFENPHARMOBEDIENTANDA 0771212005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - BACLOFENWATSON LABSANDA 07469819962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - BACLOFENYILINGANDA 07458419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - BACLOFENWATSON LABSANDA 0730921994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BACLOFENWATSON LABSANDA 0730931994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - BACLOFENTEVAANDA 0730431992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BACLOFENTEVAANDA 0730441992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - BACLOFENWATSON LABSANDA 0728241991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BACLOFENWATSON LABSANDA 0728251991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — - BACLOFENIVAX SUB TEVA PHARMSANDA 0722341988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - BACLOFENRSIVAX SUB TEVA PHARMSANDA 0722351988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - BACLOFENUSL PHARMAANDA 0712601988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BACLOFENUSL PHARMAANDA 0712611988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11446246 | in 11 yr 3 mo | U-3433 | |
| 11324696 | in 11 yr 4 mo | Product | |
| 10792262 | in 13 yr 2 mo | ProductU-3263 | |
| 11654124 | in 13 yr 2 mo | Product | |
| 11931328 | in 13 yr 2 mo | Product | |
| 10610502 | in 13 yr 3 mo | U-2779 | |
| 11850225 | in 15 yr 4 mo | ProductU-3488 | |
| 11491125 | in 15 yr 4 mo | ProductU-3488 |
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
9 mo ago
Approvals span 1982–2025 across 49 FDA applications.
Brand (NDA) 714%
Generic (ANDA) 4286%
Baclofen: 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.
