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Last Updated: December 26, 2024

TIZANIDINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Tizanidine Hydrochloride, and what generic alternatives are available?

Tizanidine Hydrochloride is a drug 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, 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 twenty-nine NDAs.

The generic ingredient in TIZANIDINE HYDROCHLORIDE 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 Tizanidine Hydrochloride

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

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Drug patent expirations by year for TIZANIDINE HYDROCHLORIDE
Recent Clinical Trials for TIZANIDINE HYDROCHLORIDE

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityEarly Phase 1
Indiana UniversityEarly Phase 1
Kuwait UniversityEarly Phase 1

See all TIZANIDINE HYDROCHLORIDE clinical trials

Pharmacology for TIZANIDINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TIZANIDINE HYDROCHLORIDE
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
Ani Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076371-001 Apr 9, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 213365-002 May 13, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Usa TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076282-002 Dec 16, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Graviti Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 218920-002 Aug 7, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076371-002 Apr 9, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cadila TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 208187-001 Mar 9, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Inc TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076286-002 Jul 3, 2002 AB RX No 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

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

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