ZANAFLEX Drug Patent Profile

When do Zanaflex patents expire, and when can generic versions of Zanaflex launch?

Zanaflex is a drug marketed by Legacy Pharma Usa and is included in two NDAs.

The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zanaflex

A generic version of ZANAFLEX was approved as tizanidine hydrochloride by DR REDDYS LABS INC on July 3^rd, 2002.

Summary for ZANAFLEX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	10
Patent Applications:	3,860
Drug Prices:	Drug price information for ZANAFLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZANAFLEX
What excipients (inactive ingredients) are in ZANAFLEX?	ZANAFLEX excipients list
DailyMed Link:	ZANAFLEX at DailyMed

See drug prices for ZANAFLEX

Recent Clinical Trials for ZANAFLEX

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

Sponsor	Phase
Henry Ford Health System	Phase 4
University of California, San Diego	Phase 2
National Center for Advancing Translational Science (NCATS)	Phase 2

See all ZANAFLEX clinical trials

Pharmacology for ZANAFLEX

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Paragraph IV (Patent) Challenges for ZANAFLEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZANAFLEX	Capsules	tizanidine hydrochloride	2 mg, 4 mg and 6 mg	021447	1	2007-08-10

US Patents and Regulatory Information for ZANAFLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-001	Aug 29, 2002	AB	RX	Yes	No
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	TABLET;ORAL	020397-002	Feb 4, 2000		DISCN	Yes	No
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002	AB	RX	Yes	No
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-003	Aug 29, 2002	AB	RX	Yes	Yes

Expired US Patents for ZANAFLEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-001	Aug 29, 2002
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-003	Aug 29, 2002
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002

International Patents for ZANAFLEX

See the table below for patents covering ZANAFLEX around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005023252

ZANAFLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZANAFLEX (Tizanidine)

Introduction to ZANAFLEX

ZANAFLEX, also known as tizanidine, is a centrally acting alpha-2 agonist widely recognized for its efficacy in reducing muscle spasticity associated with conditions such as multiple sclerosis, spinal cord injury, and other neurological disorders. Here, we delve into the market dynamics and financial trajectory of ZANAFLEX, providing a comprehensive overview of its current and future market position.

Mechanism of Action and Clinical Use

ZANAFLEX works by targeting the central nervous system to provide relief from muscle stiffness, thereby enhancing patients' quality of life. Its unique mechanism of action makes it a key player in the management of spasticity, a condition that affects millions worldwide[1].

Market Size and Forecast

The tizanidine market, which includes ZANAFLEX, was valued at USD 388.6 million in 2024 and is projected to reach USD 534.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2031. This growth is driven by several factors, including an aging population, improvements in drug administration systems, and increasing research and development activities[4].

Key Market Drivers

Aging Population

The global population is aging, particularly in industrialized nations, leading to an increased prevalence of musculoskeletal disorders. This demographic shift is expected to drive the demand for medications like tizanidine[4].

Innovations in Drug Administration

Advancements in drug administration systems, such as new delivery techniques or extended-release formulations, are likely to increase patient compliance and convenience, thereby boosting the market for tizanidine[4].

Research and Development

Ongoing research aimed at enhancing the safety and efficacy profiles of tizanidine, as well as exploring new therapeutic areas, is expected to broaden its market reach and competitiveness[4].

Growing Healthcare Expenditure

Increasing healthcare spending, especially in developing nations and areas with evolving healthcare infrastructure, will make drugs like tizanidine more accessible, fueling market expansion[4].

Market Challenges

Competition from Generics

The potential loss of patent protection for tizanidine could lead to the availability of generic equivalents, increasing competition and potentially eroding the market share of branded products[4].

Limited Knowledge and Education

The uptake and market penetration of tizanidine may be restricted by a lack of awareness among patients and healthcare professionals about the drug's benefits for specific conditions[4].

Adverse Events

Rare but serious adverse events associated with tizanidine could reduce its usage among patients and prescribers[4].

Changing Healthcare Policies

Fluctuations in healthcare policies and reimbursement structures can impact the accessibility and affordability of tizanidine[4].

Financial Performance and Revenue

Historical Revenue

In 2014, Acorda Therapeutics reported combined net revenue and royalties from ZANAFLEX and tizanidine of $3.2 million for the fourth quarter, and $12.4 million for the full year. The company also projected $25 million in revenue from the ZANAFLEX franchise and ex-U.S. FAMPYRA for 2015[2].

Market Projections

The comprehensive report by ResearchAndMarkets.com provides in-depth market projections, including forecasted sales data. This analysis presents an expansive view of the market size, growth, and emerging trends up to 2032. The report highlights that ZANAFLEX's market presence is expected to evolve significantly, driven by its therapeutic potential and strategic R&D undertakings[1].

Regulatory Landscape

Regulatory Milestones

The regulatory journey of ZANAFLEX is closely monitored, with significant events including patent information, approval history, and market access parameters. These milestones are crucial for understanding the drug's current and future market positioning[1].

Competitive Environment

Emerging Competition

The market for spasticity treatment is dynamic, with novel therapies in development. The report by ResearchAndMarkets.com highlights potential market shifts and competitive pressures, emphasizing the need for stakeholders to stay informed about emerging therapeutic candidates[1].

Key Players

Major players in the tizanidine market include Actavis, Teva, Sandoz, Acorda, Unichem Laboratories, APOTEX, Sun Pharmaceutical, CorePharma, Dr. Reddy’s Laboratories, Mylan, and others. These companies play a significant role in shaping the market through their R&D activities, marketing strategies, and product offerings[4].

Distribution Channels

Market Segmentation

The tizanidine market is segmented by dosage (low-dose, medium-dose, high-dose), distribution channels (hospital pharmacies, retail pharmacies, online pharmacies), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, Latin America). Understanding these segments is essential for navigating the market effectively[4].

Future Outlook

Strategic R&D Undertakings

The future of ZANAFLEX is closely tied to ongoing and completed clinical trials, as well as strategic R&D initiatives. These efforts are aimed at enhancing the drug's safety and efficacy profiles and exploring new therapeutic areas, which will be pivotal in maintaining its market position[1].

Market Expansion

Regulatory approvals for new indications or formulations of tizanidine could open up new market segments and revenue streams. This expansion, coupled with growing healthcare expenditure and an aging population, suggests a promising future for ZANAFLEX in the spasticity treatment market[4].

Key Takeaways

• Market Growth: The tizanidine market is projected to grow at a CAGR of 3.6% from 2024 to 2031.
• Key Drivers: Aging population, innovations in drug administration, and increasing R&D activities are driving the market.
• Challenges: Competition from generics, limited knowledge, adverse events, and changing healthcare policies pose challenges.
• Financial Performance: Historical revenue data and market projections indicate a stable financial trajectory.
• Regulatory Landscape: Monitoring regulatory milestones is crucial for market positioning.
• Competitive Environment: Emerging therapies and key players shape the competitive landscape.

FAQs

What is the primary use of ZANAFLEX?

ZANAFLEX is primarily used to reduce muscle spasticity associated with conditions such as multiple sclerosis, spinal cord injury, and other neurological disorders.

What is the projected market size of tizanidine by 2031?

The tizanidine market is projected to reach USD 534.9 million by 2031.

What are the key drivers of the tizanidine market?

Key drivers include an aging population, innovations in drug administration systems, and increasing research and development activities.

What are the major challenges facing the tizanidine market?

Challenges include competition from generics, limited knowledge and education, adverse events, and changing healthcare policies.

Who are the major players in the tizanidine market?

Major players include Actavis, Teva, Sandoz, Acorda, Unichem Laboratories, APOTEX, Sun Pharmaceutical, and others.

Sources

1. GlobeNewswire: New Research Insight on ZANAFLEX (Tizanidine) Provides In-Depth Forecast and Market Analysis Up to 2032 for Spasticity[1].
2. Acorda Therapeutics: Acorda Therapeutics Reports Fourth Quarter and Full Year 2014 Financial Results[2].
3. Minnesota Department of Human Services: Zanaflex / Minnesota Department of Human Services[3].
4. Verified Market Research: Tizanidine Market Size, Trends, Analysis, Share, Scope & Forecast[4].
5. Viatris: Viatris Q4 and Full Year 2021 Results FINAL PRESS RELEASE[5].