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Last Updated: December 24, 2024

Baclofen - Generic Drug Details


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What are the generic drug sources for baclofen and what is the scope of patent protection?

Baclofen is the generic ingredient in eight branded drugs marketed by Amneal, Heritage, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Piramal Critical, Metacel Pharms Llc, Ani Pharms, Azurity, Ucb Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, Zydus Lifesciences, and Novartis, and is included in forty-eight NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baclofen has fourteen patent family members in eight countries.

There are twenty-one drug master file entries for baclofen. Sixty-three 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
Hospices Civils de LyonPhase 2/Phase 3
University of LouisvillePhase 2
Institute of Liver and Biliary Sciences, IndiaN/A

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 DS 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
Unichem BACLOFEN baclofen TABLET;ORAL 212067-003 Mar 9, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc BACLOFEN baclofen TABLET;ORAL 077241-002 Jul 6, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc BACLOFEN baclofen TABLET;ORAL 077862-001 Aug 14, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Beximco Pharms Usa BACLOFEN baclofen TABLET;ORAL 214114-003 Sep 19, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax BACLOFEN baclofen TABLET;ORAL 077971-003 Jul 7, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Azurity FLEQSUVY baclofen SUSPENSION;ORAL 215602-001 Feb 4, 2022 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 ⤷  Subscribe ⤷  Subscribe
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 ⤷  Subscribe ⤷  Subscribe
Novartis LIORESAL baclofen TABLET;ORAL 017851-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 ⤷  Subscribe ⤷  Subscribe
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-001 Oct 30, 2003 ⤷  Subscribe ⤷  Subscribe
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for baclofen

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2023055457 ⤷  Subscribe
Canada 3036356 SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) ⤷  Subscribe
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) ⤷  Subscribe
Brazil 112022001591 Formulações estabilizadas de derivados do ácido 4-amino-3-butanóico substituídos ⤷  Subscribe
Japan 2022544901 4-アミノ-3-置換ブタン酸誘導体の安定化製剤 ⤷  Subscribe
Canada 3148812 FORMULATIONS STABILISEES DE DERIVES DE L'ACIDE BUTANOIQUE DU TYPE 4-AMINO-3-SUBSTITUES (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES) ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2018049184 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Baclofen Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Baclofen

Market Overview

Baclofen, a medication primarily used to treat muscle spasms caused by conditions such as multiple sclerosis, spinal cord injuries, and other neurological disorders, is experiencing significant growth in the global pharmaceutical market. Here are the key dynamics and financial projections for the baclofen market.

Global Market Size and Growth

The global baclofen market size surpassed USD 16,524.27 million in 2024 and is projected to reach USD 30,976.43 million by 2034, growing at a compound annual growth rate (CAGR) of 11.4% during this period[1].

Regional Market Analysis

North America

North America dominates the global baclofen market, accounting for around 38% of the market share. The high prevalence of neurological conditions such as multiple sclerosis and spinal cord injuries, coupled with well-developed healthcare infrastructure and favorable reimbursement policies, drive this dominance[1].

Europe

Europe is another significant market for baclofen, with substantial demand in countries like Germany, France, and the UK. Comprehensive healthcare systems and favorable reimbursement policies support the adoption of both oral and injectable forms of baclofen in this region[1].

Asia Pacific

The Asia Pacific region is experiencing rapid growth due to increasing healthcare awareness, rising prevalence of neurological disorders, and expanding healthcare infrastructure. Countries like China, India, and Japan are key contributors to this growth, with a primary demand for oral baclofen due to cost considerations[1].

Middle East & Africa

The Middle East and Africa region has a smaller but growing market for baclofen. While there are challenges such as limited access to advanced medical treatments and lower healthcare spending, the market is gradually expanding as awareness and availability of treatments improve[1].

Intrathecal Baclofen (ITB) Therapy Systems Market

The global market for Intrathecal Baclofen (ITB) therapy systems, which involves direct administration of baclofen into the spinal cord, was valued at USD 1.11 billion in 2022. This market is expected to grow at a CAGR of 5.2% from 2023 to 2032, reaching USD 1.84 billion by 2032. The growth is driven by increasing prevalence of conditions like cerebral palsy, multiple sclerosis, and spinal cord injuries, as well as supportive reimbursement strategies and increasing awareness of ITB therapy[2].

Key Market Drivers

Increasing Prevalence of Neurological Disorders

The rising incidence of neurological conditions such as multiple sclerosis, cerebral palsy, and spinal cord injuries is a significant driver for the baclofen market. These conditions necessitate effective treatments for muscle spasticity, making baclofen a crucial medication[1][2].

Advancements in Pharmaceutical Formulations

Improvements in pharmaceutical formulations, including the development of oral granules like LYVISPAH™, enhance patient compliance and treatment efficacy. Such innovations contribute to the market's growth[5].

Reimbursement Policies and Healthcare Infrastructure

Favorable reimbursement policies and well-developed healthcare infrastructure in regions like North America and Europe support the widespread adoption of baclofen. These factors make the treatment more accessible and affordable for patients[1][2].

Financial Performance and Projections

Current Market Size

The global baclofen market was valued at USD 16,524.27 million in 2024, with U.S. annual sales for baclofen reaching $130 million for the 12 months ended March 2022[1][3].

Future Projections

The market is expected to reach USD 30,976.43 million by 2034, growing at a CAGR of 11.4%. The ITB therapy systems market is projected to reach USD 1.84 billion by 2032, growing at a CAGR of 5.2% from 2023 to 2032[1][2].

Key Market Players

The baclofen market is dominated by several large pharmaceutical companies, including Amneal Pharmaceuticals, Novartis AG, Lunan Biopharma Co., Ltd., Teva Pharmaceutical Industries Ltd., Hikma Pharmaceuticals PLC, Mylan N.V., Cipla Ltd., Sun Pharmaceutical Industries Ltd., Aurobindo Pharma Ltd., Grunenthal Group, Endo International plc, and Piramal Enterprises Ltd.[1].

Product Innovations and Launches

Recent innovations include the FDA approval of LYVISPAH™ (baclofen) oral granules by Saol Therapeutics. This product launch, along with partnerships for patient support programs, is expected to enhance market penetration and patient accessibility[3][5].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as limited access to advanced medical treatments in certain regions and lower healthcare spending in the Middle East and Africa. Additionally, the market is competitive, with several generic and brand players vying for market share[1][3].

Opportunities

The increasing awareness of ITB therapy and the growing prevalence of neurological disorders present significant opportunities for market expansion. Investments in research and development, particularly in improving pharmaceutical formulations, are also expected to drive growth[2][4].

Key Takeaways

  • The global baclofen market is projected to grow significantly, driven by increasing prevalence of neurological disorders and advancements in pharmaceutical formulations.
  • North America and Europe are the dominant regions, with the Asia Pacific region showing rapid growth.
  • Favorable reimbursement policies and well-developed healthcare infrastructure are key drivers.
  • The ITB therapy systems market is also growing, driven by the need for effective spasticity management.
  • Key market players are investing in product innovations and patient support programs to enhance market penetration.

FAQs

1. What is the current market size of the global baclofen market?

The global baclofen market size surpassed USD 16,524.27 million in 2024[1].

2. What is the projected growth rate of the baclofen market from 2024 to 2034?

The baclofen market is expected to grow at a CAGR of 11.4% from 2024 to 2034[1].

3. Which regions dominate the global baclofen market?

North America and Europe are the dominant regions, with North America accounting for around 38% of the market share[1].

4. What is the significance of Intrathecal Baclofen (ITB) therapy systems in the market?

ITB therapy systems involve direct administration of baclofen into the spinal cord, reducing systemic adverse effects. This market is expected to grow at a CAGR of 5.2% from 2023 to 2032[2].

5. Who are the key players in the baclofen market?

The market is dominated by companies such as Amneal Pharmaceuticals, Novartis AG, Lunan Biopharma Co., Ltd., Teva Pharmaceutical Industries Ltd., and others[1].

Cited Sources:

  1. We Market Research - Global Baclofen Market Size | 2024-2034[1]
  2. GlobeNewswire - Global Intrathecal Baclofen (ITB) Therapy Systems Market[2]
  3. Amneal Pharmaceuticals - Amneal Launches LYVISPAH® (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders[3]
  4. Market Research Intellect - Baclofen Market Size, Growth, Share | Analysis by 2031[4]
  5. Saol Therapeutics - Saol Therapeutics Announces FDA Approval of LYVISPAH™ (baclofen) Oral Granules[5]

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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.