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Last Updated: December 23, 2024

TIZANIDINE Drug Patent Profile


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When do Tizanidine patents expire, and what generic alternatives are available?

Tizanidine 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 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

A generic version of TIZANIDINE 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
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US Patents and Regulatory Information for TIZANIDINE

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tizanidine

Introduction to Tizanidine

Tizanidine is a short-acting muscle relaxant widely used for the treatment of muscle spasticity associated with conditions such as multiple sclerosis, spinal cord injuries, and acquired brain injuries. Its market dynamics are influenced by several key factors, including growing demand, advancements in drug formulations, and changing healthcare policies.

Market Size and Growth Projections

The tizanidine market has been valued at USD 350 million in 2023 and is projected to reach USD 520 million by 2031, growing at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Neurological Conditions

The rising frequency of neurological diseases such as multiple sclerosis, cerebral palsy, and spinal cord injuries is a significant driver of the tizanidine market. As these conditions become more common, the demand for effective muscle relaxants like tizanidine increases[1][4].

Advancements in Drug Formulations and Delivery Systems

Improvements in medication formulations, such as extended-release tablets and new delivery techniques, enhance the effectiveness and patient compliance of tizanidine. These innovations contribute to the market's growth by making the drug more convenient and efficient[1][4].

Growing Senior Population

The aging population, particularly in industrialized nations, is more prone to musculoskeletal disorders that require muscle relaxation. This demographic shift drives the demand for tizanidine and other muscle relaxants[1][4].

Increasing Recognition and Prescription Rates

Greater awareness among medical professionals about the benefits of tizanidine in treating spasticity and muscular spasms leads to higher prescription rates. Increased diagnosis rates of musculoskeletal disorders also contribute to the market's expansion[1][4].

Market Restraints and Challenges

Competition from Generics

The potential loss of patent protection for tizanidine could lead to the introduction of generic equivalents, which could reduce the market share and sales of branded products[4].

Limited Knowledge and Education

Lack of awareness among patients and healthcare professionals about the benefits of tizanidine for specific ailments can limit its market penetration and uptake[4].

Adverse Events

Rare but serious adverse events associated with tizanidine, such as rebound hypertension and tachycardia, can deter patients and prescribers from using the drug[4].

Changing Healthcare Policies

Changes in healthcare organizations' formularies or policies related to access and reimbursement of tizanidine can impact its market demand[4].

Market Segmentation

By Product Type

The tizanidine market is segmented into various product types, including tizanidine tablets, capsules, and other forms such as patches and injectable forms[4].

By Dosage

The market is also segmented by dosage, including low-dose (e.g., 2 mg), medium-dose (e.g., 4 mg), and high-dose (e.g., 6 mg or higher) formulations[4].

By Distribution Channel

Tizanidine is distributed through various channels, including hospital pharmacies, retail pharmacies, online pharmacies, and specialty pharmacies[4].

By Geography

The global tizanidine market is segmented geographically into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America[1][4].

Key Players

Major players in the tizanidine market include Actavis, Teva, Sandoz, Acorda, Unichem Laboratories, APOTEX, Sun Pharmaceutical, CorePharma, Dr. Reddy’s Laboratories, and Mylan, among others[4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the tizanidine market. While it has disrupted supply chains and affected healthcare services, it has also highlighted the importance of effective treatments for musculoskeletal disorders, potentially increasing demand for tizanidine in the long term[4].

Emerging Trends and Opportunities

Research and Development Activities

Ongoing research and development aimed at enhancing the safety and efficacy profiles of tizanidine, as well as exploring new therapeutic areas, can broaden the market reach and boost competitiveness[4].

Growing Healthcare Expenditure

Increasing healthcare spending, particularly in developing nations and regions with evolving healthcare infrastructure, can make drugs like tizanidine more accessible and fuel market expansion[4].

Regulatory Approvals

Regulatory approvals for new tizanidine indications or formulations can open up new market segments and revenue streams for pharmaceutical companies[4].

Financial Trajectory

The financial trajectory of the tizanidine market is characterized by steady growth driven by increasing demand and advancements in drug formulations. Here are some key financial highlights:

  • Market Size: The tizanidine market was valued at USD 350 million in 2023 and is expected to reach USD 520 million by 2031[1].
  • CAGR: The market is growing at a CAGR of 5.2% from 2024 to 2031[1].
  • Revenue Streams: The market is driven by sales through various distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies[4].
"Tizanidine's growing use as a muscle relaxant for the treatment of spasticity brought on by neurological diseases is driving the market's rapid rise. The aging population and increasing frequency of diseases like multiple sclerosis and spinal cord injuries are driving up the need for efficient muscle relaxants."[1]

Key Takeaways

  • The tizanidine market is expected to grow significantly due to the increasing prevalence of neurological conditions and advancements in drug formulations.
  • The market is driven by a growing senior population and increased recognition among medical professionals.
  • Challenges include competition from generics, limited knowledge and education, and adverse events.
  • The market is segmented by product type, dosage, distribution channel, and geography.
  • Key players are investing in research and development to enhance the drug's safety and efficacy.

Frequently Asked Questions (FAQs)

1. What is the primary use of tizanidine?

Tizanidine is primarily used for the treatment of muscle spasticity associated with conditions such as multiple sclerosis, spinal cord injuries, and acquired brain injuries.

2. What are the key drivers of the tizanidine market?

The key drivers include the increasing prevalence of neurological conditions, advancements in drug formulations, a growing senior population, and increased recognition among medical professionals.

3. What are the potential restraints on the tizanidine market?

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

4. How is the tizanidine market segmented?

The market is segmented by product type (tablets, capsules, etc.), dosage (low-dose, medium-dose, high-dose), distribution channel (hospital pharmacies, retail pharmacies, etc.), and geography (North America, Europe, etc.).

5. What is the projected growth rate of the tizanidine market?

The tizanidine market is expected to grow at a CAGR of 5.2% from 2024 to 2031[1].

Sources:

  1. Market Research Intellect - Tizanidine Market Size and Projections[1]
  2. The Inner Ring - Traces of Tizanidine[2]
  3. Wicz - Tizanidine Market Size and Growth Analysis 2024-2032[3]
  4. Verified Market Research - Tizanidine Market Size, Trends, Analysis, Share, Scope & Forecast[4]
  5. Grove Treatment - Tizanidine Addiction: Effects, Risks, Symptoms, Causes & Treatment[5]

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