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Last Updated: November 27, 2022

Baclofen - Generic Drug Details


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What are the generic drug sources for baclofen and what is the scope of freedom to operate?

Baclofen is the generic ingredient in seven branded drugs marketed by Amneal, Maia Pharms Inc, Mylan Labs Ltd, Piramal Critical, Metacel Pharms Llc, Azurity, Ucb Inc, Aurobindo Pharma Ltd, Beximco Pharms Usa, Eywa Pharma, Impax, Innogenix, Ivax Sub Teva Pharms, Kartha, Lannett Co Inc, Mankind Pharma, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Oxford Pharms, Rubicon, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Vintage Pharms, Watson Labs, Zydus, and Novartis, and is included in forty-three NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baclofen has ten patent family members in six countries.

There are twenty-one drug master file entries for baclofen. Forty-six suppliers are listed for this compound.

Drug Prices for baclofen

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Drug Sales Revenue Trends for baclofen

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Recent Clinical Trials for baclofen

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPhase 2/Phase 3
Bhupesh Parashar, MDPhase 2
University of Texas Southwestern Medical CenterPhase 1

See all baclofen clinical trials

Pharmacology for baclofen
Medical Subject Heading (MeSH) Categories for baclofen
Paragraph IV (Patent) Challenges for BACLOFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLEQSUVY Oral Suspension baclofen 25 mg/5 mL 215602 1 2022-05-20
OZOBAX Oral Solution baclofen 5 mg/5 mL 208193 1 2021-07-26

US Patents and Regulatory Information for baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc BACLOFEN baclofen TABLET;ORAL 077862-002 Aug 14, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unichem BACLOFEN baclofen TABLET;ORAL 212067-001 Jul 9, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd BACLOFEN baclofen TABLET;ORAL 214099-002 Jul 13, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Maia Pharms Inc BACLOFEN baclofen INJECTABLE;INTRATHECAL 210777-001 Jan 15, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs BACLOFEN baclofen TABLET;ORAL 074698-002 Aug 20, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-001 Oct 30, 2003 See Plans and Pricing See Plans and Pricing
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 See Plans and Pricing See Plans and Pricing
Novartis LIORESAL baclofen TABLET;ORAL 017851-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 See Plans and Pricing See Plans and Pricing
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for baclofen

Country Patent Number Title Estimated Expiration
Canada 3036356 SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) See Plans and Pricing
European Patent Office 3509592 SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) See Plans and Pricing
European Patent Office 4003323 FORMULATIONS STABILISÉES DE DÉRIVÉS DE L'ACIDE BUTANOÏQUE DU TYPE 4-AMINO-3-SUBSTITUÉS (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES) See Plans and Pricing
China 114450002 4-氨基-3-取代的丁酸衍生物的稳定制剂 (Stable formulations of 4-amino-3-substituted butyric acid derivatives) See Plans and Pricing
China 109922801 甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Baxter
Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.