TIZANIDINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for tizanidine hydrochloride and what is the scope of patent protection?

Tizanidine hydrochloride is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Endo Operations, Jubilant Generics, Norvium Bioscience, Novast Labs, Rubicon, Somerset Theraps Llc, Zydus Pharms, Legacy Pharma Usa, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Graviti Pharms, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for tizanidine hydrochloride. Fifty-five suppliers are listed for this compound.

Summary for TIZANIDINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	25
NDAs:	31
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	30
Patent Applications:	1,968
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIZANIDINE HYDROCHLORIDE
What excipients (inactive ingredients) are in TIZANIDINE HYDROCHLORIDE?	TIZANIDINE HYDROCHLORIDE excipients list
DailyMed Link:	TIZANIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TIZANIDINE HYDROCHLORIDE

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Early Phase 1
Indiana University	Early Phase 1
Kuwait University	Early Phase 1

See all TIZANIDINE HYDROCHLORIDE clinical trials

Pharmacology for TIZANIDINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for TIZANIDINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for TIZANIDINE HYDROCHLORIDE

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 TIZANIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadila Pharms Ltd	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	210021-003	Mar 26, 2019	AB	RX	No	No
Unichem Labs Ltd	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	091283-001	Nov 28, 2012	AB	RX	No	No
Oxford Pharms	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076281-001	Oct 20, 2003	AB	RX	No	No
Sun Pharm Inds Inc	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	TABLET;ORAL	076416-001	Sep 29, 2003	AB	RX	No	No
Cadila Pharms Ltd	TIZANIDINE HYDROCHLORIDE	tizanidine hydrochloride	CAPSULE;ORAL	210021-002	Mar 26, 2019	AB	RX	No	No

Expired US Patents for TIZANIDINE HYDROCHLORIDE

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	6,455,557
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-003	Aug 29, 2002	6,455,557
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002	6,455,557

TIZANIDINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tizanidine Hydrochloride

Introduction to Tizanidine Hydrochloride

Tizanidine hydrochloride, a centrally acting α2-adrenergic agonist, is primarily used to manage spasticity associated with conditions such as multiple sclerosis, spinal cord injuries, and other musculoskeletal ailments. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Forecast

The tizanidine market has been 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[3].

Market Drivers

Rising Frequency of Musculoskeletal Diseases

The increasing prevalence of musculoskeletal diseases, such as spasticity and muscular spasms, drives the demand for tizanidine. Factors like aging populations and sedentary lifestyles contribute to the rising incidence of these conditions[3].

Increasing Recognition and Diagnosis Rates

Improved knowledge about musculoskeletal disorders and better diagnostic techniques lead to higher diagnosis rates, which in turn increase the prescription rates of tizanidine[3].

Growing Senior Population

The global population is aging, particularly in industrialized nations, leading to a higher incidence of musculoskeletal disorders and an increased need for medications like tizanidine[3].

Improvements in Drug Administration Systems

Innovations in drug delivery systems, such as new delivery techniques or extended-release formulations, enhance patient compliance and convenience, driving market growth[3].

Increasing Research and Development Activities

Ongoing research aimed at enhancing the safety and efficacy profiles of tizanidine, as well as exploring new therapeutic areas, can expand the market reach and competitiveness of the drug[3].

Growing Healthcare Expenditure

Increasing healthcare spending, especially in developing nations and areas with evolving healthcare infrastructure, makes drugs like tizanidine more accessible, fueling market expansion[3].

Market Restraints

Limited Coverage or Reimbursement

Limited coverage or reimbursement by health insurance programs can impact patients' access to and affordability of tizanidine, restricting market growth[3].

Competition from Generics

The potential loss of patent protection for tizanidine could lead to the availability of generic equivalents, increasing competition and potentially reducing sales and market share of branded products[3].

Limited Knowledge and Education

Lack of awareness among patients and healthcare professionals about the benefits of tizanidine for specific ailments can limit its uptake and market penetration[3].

Adverse Events

Rare but serious adverse events associated with tizanidine, such as liver injury and hypotension, can deter patients and prescribers, affecting market demand[5].

Changing Healthcare Policies

Changes in healthcare organizations' formularies or policies related to access and reimbursement of tizanidine can impact its market demand[3].

Market Opportunities

Regulatory Approvals and Market Expansion

Regulatory approvals for new indications or formulations of tizanidine can open up new market segments and revenue streams for pharmaceutical companies[3].

Emerging Technologies

Advancements in drug delivery systems and other technological developments can shift demand towards more convenient or effective alternatives, presenting opportunities for innovation and growth[3].

Competitive Landscape

The tizanidine market is competitive, with major players including Actavis, Teva, Sandoz, Acorda, Unichem Laboratories, APOTEX, Sun Pharmaceutical, CorePharma, Dr. Reddy’s Laboratories, and Mylan, among others[3].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, online pharmacies, and specialty pharmacies. Each channel plays a significant role in making tizanidine accessible to patients[3].

Geographical Analysis

The global tizanidine market is segmented geographically into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region has its own market dynamics influenced by local healthcare infrastructure, regulatory environments, and patient demographics[3].

Financial Performance and Projections

The financial trajectory of tizanidine is marked by steady growth, driven by increasing demand and expanding market reach. Here are some key financial projections:

• Market Size: Expected to grow from USD 388.6 million in 2024 to USD 534.9 million by 2031[3].
• CAGR: Projected at 3.6% from 2024 to 2031[3].
• Revenue Streams: New market segments and revenue streams are expected to open up through regulatory approvals and innovations in drug delivery systems[3].

Key Takeaways

• The tizanidine market is driven by the rising frequency of musculoskeletal diseases and improvements in drug administration systems.
• Market growth is restrained by factors such as limited coverage or reimbursement and competition from generics.
• Regulatory approvals and emerging technologies present significant opportunities for market expansion.
• The competitive landscape is diverse, with several major pharmaceutical companies involved.
• Geographical segmentation highlights varying market dynamics across different regions.

FAQs

What is the primary use of tizanidine hydrochloride?

Tizanidine hydrochloride is primarily used to manage spasticity associated with conditions such as multiple sclerosis, spinal cord injuries, and other musculoskeletal ailments[5].

What are the key drivers of the tizanidine market?

Key drivers include the rising frequency of musculoskeletal diseases, increasing recognition and diagnosis rates, growing senior population, improvements in drug administration systems, and increasing research and development activities[3].

What are the major restraints on the tizanidine market?

Major restraints include limited coverage or reimbursement, competition from generics, limited knowledge and education, adverse events, and changing healthcare policies[3].

Who are the major players in the tizanidine market?

Major players include Actavis, Teva, Sandoz, Acorda, Unichem Laboratories, APOTEX, Sun Pharmaceutical, CorePharma, Dr. Reddy’s Laboratories, and Mylan[3].

What is the projected CAGR for the tizanidine market from 2024 to 2031?

The projected CAGR for the tizanidine market from 2024 to 2031 is 3.6%[3].

Sources

1. BCC Research - Pharma 4.0 and Digital Manufacturing Market Report
2. FDA - Zanaflax (Tizanidine HCL) Oral Tabs 4MG
3. Verified Market Research - Tizanidine Market Size, Trends, Analysis, Share, Scope & Forecast
4. Cognitive Market Research - Global Tizanidine HCl Market Report 2024 Edition
5. DailyMed - Tizanidine Hydrochloride Tablets 2 mg and 4 mg