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, Pharmobedient, Rubicon Research, Piramal Critical, Metacel Pharms Llc, Ani Pharms, Azurity, Ucb Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Hibrow Hlthcare, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Oxford Pharms, Ph Health, Regcon Holdings, Rising, Sun Pharm Inds Inc, Teva, Unichem, Usl Pharma, Watson Labs, Yiling, Zydus Lifesciences, and Novartis, and is included in forty-nine 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-one suppliers are listed for this compound.

Summary for BACLOFEN

International Patents:	14
US Patents:	8
Tradenames:	8
Applicants:	32
NDAs:	49
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	61
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	130
Patent Applications:	7,596
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
Adnan Imtiaj Rahul	PHASE2
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal	PHASE4
McMaster University	PHASE3

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
Teva	BACLOFEN	baclofen	TABLET;ORAL	073043-001	Feb 27, 1992		DISCN	No	No
Rising	BACLOFEN	baclofen	TABLET;ORAL	214374-002	Mar 5, 2021	AB	RX	No	No
Rising	BACLOFEN	baclofen	TABLET;ORAL	214374-001	Mar 5, 2021	AB	RX	No	No
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003		DISCN	Yes	No
Rubicon Research	BACLOFEN	baclofen	TABLET;ORAL	209102-004	Feb 5, 2024	AB	RX	No	No
Pharmobedient	BACLOFEN	baclofen	INJECTABLE;INTRATHECAL	209592-001	Mar 21, 2018	AP	RX	No	No
Ph Health	BACLOFEN	baclofen	TABLET;ORAL	077068-002	Aug 30, 2005	AB	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	3,471,548
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	6,024,981
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982	3,471,548
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003	6,221,392
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	6,024,981
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003	6,221,392

International Patents for BACLOFEN

Country	Patent Number	Title	Estimated Expiration
China	109922801	甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
Australia	2020323846	Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
World Intellectual Property Organization (WIPO)	2023055457
World Intellectual Property Organization (WIPO)	2018049184
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
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)

Market Dynamics and Financial Trajectory for Baclofen (Lioresal)

Last updated: January 15, 2026

Executive Summary

Baclofen, primarily marketed as Lioresal, is a GABA_B receptor agonist used for managing spasticity associated with multiple sclerosis (MS), spinal cord injuries, and various neurological disorders. The global baclofen market exhibits steady growth driven by increasing prevalence of neurological conditions, ongoing research into expanded therapeutic indications, and advancements in delivery formulations. Currently valued at approximately USD 900 million (2022), forecasts project a compounded annual growth rate (CAGR) of 4-6% over the next five years. This growth is influenced by regulatory approvals, patent landscapes, emerging biosimilars, and macroeconomic factors, including healthcare expenditure and drug pricing policies.

This report provides a detailed analysis of the market's key drivers, challenges, competitive landscape, and future financial trajectories, aiding pharmaceutical stakeholders' strategic planning.

---

Market Overview and Current Landscape

Parameter	Detail
Market Size (2022)	Approximately USD 900 million
CAGR (2023-2028)	4-6%
Key Geographic Markets	North America, Europe, Asia-Pacific
Major Players	Pfizer (Lioresal), TEVA, Mylan, Sandoz, Sun Pharmaceutical

Key Therapeutic Indications:

• Spasticity in MS and spinal cord injury
• Off-label uses include drug addiction management and dystonia management

Formulations:

• Oral tablets (most common)
• Intrathecal baclofen (ITB pumps) for severe cases
• Injectable forms

The market is characterized by a relatively stable demand in developed economies and emerging opportunities in developing markets.

---

What Are the Market Drivers for Baclofen?

1. Rising Prevalence of Neurological Disorders

According to the WHO, MS affects over 2.8 million globally, with a rising incidence in Asia and Latin America. Spinal cord injuries are projected to affect up to 30 per million annually in developed countries. This escalation fuels the demand for effective spasticity management treatments.

2. Adoption of Intrathecal Baclofen (ITB) Therapy

ITB delivery systems have gained prominence for severe spasticity management. The global ITB pump market was valued at USD 140 million in 2022, with a CAGR of approximately 11%. Increasing adoption of implantable pumps in North America and Europe enhances the financial trajectory for baclofen.

3. Regulatory Approvals and Expanded Indications

Recent approvals of baclofen formulations for new indications, including off-label uses, notably in alcohol dependence and dystonia, extend market reach.

4. Technological Innovations and Formulation Improvements

Development of controlled-release formulations and minimally invasive delivery systems reduce side effects and improve patient compliance, driving market expansion.

5. Strategic Collaborations and Patent Expirations

Patents expiring from 2026 in key markets open avenues for biosimilar entry, intensifying competitive dynamics and pricing pressures.

---

What Are the Challenges Facing the Baclofen Market?

1. Patent Expirations and Biosimilar Competition

Generic and biosimilar entrants from 2026 threaten to reduce pricing premiums, with potential revenue drops estimated between 15-20%.

2. Side Effect Profile and Off-Label Risks

Adverse effects such as hypotonia, seizures, and withdrawal pose clinical hurdles. Regulatory scrutiny over off-label use can impact market confidence.

3. Market Penetration in Emerging Economies

Limited healthcare infrastructure and regulatory inconsistencies in emerging markets constrain growth.

4. Reimbursement and Pricing Policies

Stringent healthcare budgets and drug cost containment measures like reference pricing impact profit margins.

---

Competitive Landscape and Key Players

Company	Lead Product	Market Share (Est.)	Strategic Moves
Pfizer	Lioresal	45%	Pipeline expansion, ITB innovations
TEVA	Generic Baclofen	20%	Cost leadership, biosimilars planning
Mylan	Mylan Baclofen	10%	Geographic expansion
Sandoz	Sandoz Baclofen	8%	Biosimilar development
Sun Pharmaceutical	Generic baclofen	3-5%	Market penetration in Asia

Recent Strategic Trends:

• Alliances with biotech firms for novel delivery systems
• Licensing agreements for biosimilar production
• R&D investments for expanding indications

---

Financial Trajectory and Market Forecast (2023-2028)

Year	Market Size (USD Million)	Compound Annual Growth Rate (CAGR)	Notes
2023	950	-	Pandemic recovery effects
2024	990	4.4%	Increasing ITB adoption
2025	1,045	5.5%	Biosimilar entry anticipated
2026	1,130	8.0%	Patent expirations; biosimilar competition
2027	1,200	6.2%	Regulatory approvals; market expansion
2028	1,260	5.0%	Stable demand; innovation scaling

Key Financial Factors:

• Pricing dynamics: Slight declines expected due to biosimilar competition.
• Unit sales: Increased adoption of ITB delivery boosting per-patient revenue.
• Regulatory landscape: Slow, allowing for sustained revenue streams in mature markets.

---

Regulatory and Policy Environment

1. FDA and EMA Approvals

• The FDA approved intrathecal baclofen (Lioresal Intrathecal) for severe pediatric spasticity management in 2016.
• The EMA approved generic baclofen formulations in 2019, fostering cost competition.

2. Reimbursement Policies

Adjusted to value-based care models, reimbursement for implantable pump therapy varies, influencing profitability.

3. Patent Landscape

Major patents scheduled to expire between 2026-2028, opening the market for biosimilars and generics.

4. International Market Variances

In emerging markets like India, regulatory pathways favor local generics, but pricing pressures are intense.

---

Comparative Analysis of Formulations and Delivery Systems

Formulation	Advantages	Limitations	Key Market Players
Oral Tablets	Ease of use	Limited efficacy for severe cases	Pfizer, Mylan
Intrathecal Baclofen	High efficacy in severe cases	Surgical implantation, side effects	Medtronic, Boston Scientific
Injectable	Rapid action	Short duration, discomfort	Sandoz, Sun Pharma
Extended-release	Potential compliance improvements	Developmental stage	Ongoing research

---

Future Outlook and Investment Considerations

• Emerging Markets: Rapid economic growth underpins increasing healthcare infrastructure and urbanization, creating new demand.
• Technological Innovation: Development in digital health, remote pump monitoring, and personalized dosing can enhance market value.
• Regulatory Environment: Evolving policies favoring biosimilar uptake necessitate strategic planning.
• Pipeline Developments: Off-label uses and new formulations under preclinical/clinical phases can further boost growth.

---

Key Takeaways

• The global baclofen market is projected to grow at a CAGR of 4-6%, reaching USD 1.26 billion by 2028.
• Market growth driven by rising neurological disorder prevalence, technological advances, and expanding indications.
• Patent expirations from 2026 pose both challenges and opportunities via biosimilar competition.
• Intrathecal formulations are a key growth segment due to their superior efficacy in severe cases.
• Strategic focus should include innovation, diversification of formulations, and entering emerging markets.

---

FAQs

Q1: What factors most significantly influence the price of baclofen?
A: Patent expirations, biosimilar market entry, manufacturer competition, healthcare reimbursement policies, and production costs.

Q2: How will biosimilar entry post-2026 affect market revenues?
A: Likely a 15-20% reduction in average selling prices, intensifying price competition and prompting innovation.

Q3: What are the primary therapeutic indications for baclofen?
A: Spasticity management in MS and spinal cord injuries, with off-label use in dystonia, alcohol dependence, and other neurological disorders.

Q4: Which regions present the highest growth potential?
A: Asia-Pacific and Latin America due to increasing neurological disorder prevalence and expanding healthcare access.

Q5: How is the market responding to demands for improved delivery systems?
A: Innovations include implantable pump technologies, sustained-release formulations, and remote monitoring systems.

---

References

[1] World Health Organization. (2021). Multiple sclerosis: facts and figures.
[2] MarketWatch. (2022). Baclofen Market Size, Share & Trends.
[3] FDA. (2016). Approval of Intrathecal Baclofen for Pediatric Spasticity.
[4] European Medicines Agency. (2019). Generic Baclofen Approvals.
[5] Grand View Research. (2022). Intrathecal Pump Market Analysis.