BACLOFEN - Generic Drug Details

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

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.

Summary for BACLOFEN

International Patents:	14
US Patents:	8
Tradenames:	8
Applicants:	34
NDAs:	48
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	63
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	126
Patent Applications:	6,933
Drug Prices:	Drug price trends for BACLOFEN
Drug Sales Revenues:	Drug sales revenues for BACLOFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BACLOFEN
What excipients (inactive ingredients) are in BACLOFEN?	BACLOFEN excipients list
DailyMed Link:	BACLOFEN at DailyMed

See drug prices for BACLOFEN

See drug sales revenues for BACLOFEN

Recent Clinical Trials for BACLOFEN

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

Sponsor	Phase
Hospices Civils de Lyon	Phase 2/Phase 3
University of Louisville	Phase 2
Institute of Liver and Biliary Sciences, India	N/A

See all BACLOFEN clinical trials

Pharmacology for BACLOFEN

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for BACLOFEN

GABA-B Receptor Agonists

Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for BACLOFEN

M03BX	Other centrally acting agents
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		RX	Yes	Yes			Y
Unichem	BACLOFEN	baclofen	TABLET;ORAL	212067-002	Jul 9, 2020	AB	RX	No	No
Rising	BACLOFEN	baclofen	TABLET;ORAL	214374-003	Mar 5, 2021	AB	RX	No	No
Impax	BACLOFEN	baclofen	TABLET;ORAL	077971-002	Oct 26, 2007		DISCN	No	No
Eywa	BACLOFEN	baclofen	TABLET;ORAL	211555-002	Feb 1, 2019	BX	RX	No	No

Expired US Patents for BACLOFEN

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

International Patents for BACLOFEN

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3509592	SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
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)
China	109922801	甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
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)
Australia	2020323846	Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives

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]