RASAGILINE MESYLATE - Generic Drug Details

What are the generic drug sources for rasagiline mesylate and what is the scope of freedom to operate?

Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Ryan Labs, Skg Pharma, and Watson Labs Inc, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rasagiline mesylate has twenty-six patent family members in eighteen countries.

There are eighteen drug master file entries for rasagiline mesylate. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RASAGILINE MESYLATE

International Patents:	26
US Patents:	2
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	14
Patent Applications:	337
Drug Prices:	Drug price trends for RASAGILINE MESYLATE
What excipients (inactive ingredients) are in RASAGILINE MESYLATE?	RASAGILINE MESYLATE excipients list
DailyMed Link:	RASAGILINE MESYLATE at DailyMed

See drug prices for RASAGILINE MESYLATE

Recent Clinical Trials for RASAGILINE MESYLATE

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

Sponsor	Phase
Teva Pharmaceutical Industries	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 1
Teva Pharmaceutical Industries	Phase 4

See all RASAGILINE MESYLATE clinical trials

Generic filers with tentative approvals for RASAGILINE MESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 1MG BASE	TABLET;ORAL
		EQ 0.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RASAGILINE MESYLATE

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RASAGILINE MESYLATE

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for RASAGILINE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZILECT	Tablets	rasagiline mesylate	0.5 mg and 1 mg	021641	5	2010-05-17

US Patents and Regulatory Information for RASAGILINE MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	208866-001	Jun 28, 2024	AB	RX	No	No
Indoco	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	206153-002	Oct 4, 2019	AB	RX	No	No
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes			Y
Ryan Labs	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201942-001	Nov 18, 2021		DISCN	No	No

Expired US Patents for RASAGILINE MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006

International Patents for RASAGILINE MESYLATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1103366	改良含量統性的雷沙吉蘭配方 (RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY)
Canada	2600011	PREPARATIONS DE RASAGILINE PRESENTANT UNE UNIFORMITE DE TENEUR AMELIOREE (RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY)
South Korea	20070111534	RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY
Spain	2586412

Supplementary Protection Certificates for RASAGILINE MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0812190	31/2005	Austria		PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190	05C0033	France		PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
0812190	C300205	Netherlands		PRODUCT NAME: RASAGILINE, DESGEWENST IN DE VORM VAN EENFARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/04/304/001 T/M 007 20050221
0812190	SPC/GB05/042	United Kingdom		PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221

RASAGILINE MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rasagiline Mesylate

Introduction to Rasagiline Mesylate

Rasagiline mesylate, known by its chemical name TVP-1012, is a potent, selective, non-reversible monoamine oxidase B (MAO-B) inhibitor. It is widely used in the treatment of Parkinson's disease (PD), particularly for its neuroprotective properties and lack of tyramine-potentiating effects[2].

Market Size and Growth Projections

The global rasagiline mesylate market has been experiencing significant growth in recent years. As of 2023, the market size was valued at several billion USD, and it is anticipated to reach even higher values by 2031. This growth is driven by increasing demand in the downstream market, particularly in the pharmaceutical and healthcare sectors[1][4].

Segmentation of the Market

The rasagiline mesylate market is segmented based on several key factors:

By Type

• Above 98%
• Above 99% These purity levels are crucial for different applications and regulatory requirements[1].

By Application

• Tablets: This is the primary form in which rasagiline mesylate is administered.
• Others: This includes other formulations and uses, though tablets are the dominant form[1].

By Geography

• North America
• Europe
• Asia-Pacific (APAC)
• South America
• Middle East and Africa Each region has its own market dynamics, influenced by local healthcare policies, patient demographics, and economic conditions[1].

Drivers of Market Growth

Several factors are driving the growth of the rasagiline mesylate market:

Increasing Prevalence of Parkinson's Disease

The rising incidence of Parkinson's disease globally is a significant driver. As the population ages, the demand for effective treatments like rasagiline mesylate increases[2].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in emerging markets, are enhancing access to advanced treatments, including rasagiline mesylate[1].

Regulatory Approvals and Compliance

Stringent regulatory standards ensure the quality and safety of rasagiline mesylate, which in turn boosts market confidence and growth[4].

Restraints and Challenges

Despite the growth, the market faces several challenges:

Competition from Generic Drugs

The presence of generic versions of rasagiline mesylate can reduce the market share of branded products, impacting revenue[4].

Side Effects and Adverse Reactions

While rasagiline mesylate has a good safety profile, any adverse reactions can affect patient compliance and market growth[2].

Economic Factors

Economic downturns and changes in healthcare policies can impact the affordability and accessibility of the drug, affecting market dynamics[1].

Opportunities

The market also presents several opportunities:

Emerging Markets

Regions like APAC and South America offer significant growth potential due to their large and growing populations and improving healthcare systems[1].

Research and Development

Continued R&D in neuroprotective treatments and combination therapies (e.g., with pramipexole) can expand the market for rasagiline mesylate[5].

Increasing Awareness and Early Diagnosis

Better awareness and early diagnosis of Parkinson's disease can lead to earlier treatment initiation, increasing the demand for rasagiline mesylate[2].

Competitive Landscape

The rasagiline mesylate market is highly competitive, with several key players:

Major Companies

• Jai Radhe Sales
• Mylan
• Beijing Mesochem Technology
• Tai Heng Industry Co. Ltd
• Glenmark Pharmaceuticals
• Maprimed S.A.
• Indoco Remedies Limited
• Amino Chemicals
• Micro Labs Limited
• Everlight Chemical
• Biotechnica Pharma Global
• Nosch Labs Pvt. Ltd.
• CHEMO
• Maithili Life Sciences Private Limited
• Ningbo Zhenlei Chemical Co. Ltd
• SGMR Pharmaceuticals
• Guangzhou Tosun Pharmaceutical[1].

These companies are involved in various activities such as new product releases, collaborations, mergers and acquisitions, and regional expansions to maintain their market presence.

Financial Trajectory

The financial trajectory of the rasagiline mesylate market is positive, with projected growth rates indicating a robust expansion from 2023 to 2031. Here are some key financial insights:

Revenue Projections

The market is expected to grow from its current value to several billion USD by 2031, driven by increasing demand and expanding applications[1][4].

Pricing Analysis

Product pricing plays a crucial role, with factors such as production costs, regulatory compliance, and market competition influencing the final prices. The report includes a detailed pricing analysis to understand the market dynamics better[1].

Investment Opportunities

The growing demand and positive market outlook make the rasagiline mesylate market an attractive sector for investments. New business ventures and investment opportunities are emerging, particularly in regions with high growth potential[1].

Market Outlook and Trends

Porter's 5 Forces Framework

The market analysis includes an examination using Porter's 5 Forces Framework, which helps in understanding the competitive intensity, bargaining power of suppliers and buyers, threat of new entrants, and the threat of substitute products[1].

Macroeconomic Investigation

The report also includes a macroeconomic investigation to understand the broader economic, political, and social landscapes that influence the market. This includes factors such as GDP growth, healthcare policies, and demographic changes[1].

Value Chain Scrutiny

A detailed scrutiny of the value chain from raw material sourcing to end-product distribution helps in identifying key areas for improvement and opportunities for growth[1].

Clinical Effectiveness and Safety

Rasagiline mesylate has been shown to have a beneficial clinical effect in patients with Parkinson's disease, particularly those with motor fluctuations. Studies have demonstrated a significant reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) scores, indicating improved patient outcomes. The safety and tolerability of rasagiline mesylate are also well-documented, with adverse events similar to those in the placebo group[2].

"Rasagiline (up to 2 mg/day) has a good safety profile and a beneficial clinical effect in fluctuating patients with PD when given as an add-on to chronic levodopa therapy."[2]

Key Takeaways

• The rasagiline mesylate market is expected to grow significantly from 2023 to 2031, driven by increasing demand and expanding applications.
• The market is segmented by type, application, and geography, with tablets being the primary form of administration.
• Key drivers include the rising prevalence of Parkinson's disease, advancements in healthcare infrastructure, and regulatory approvals.
• Challenges include competition from generic drugs, side effects, and economic factors.
• Emerging markets and R&D in neuroprotective treatments present significant opportunities.
• The competitive landscape is dominated by several major pharmaceutical and chemical companies.

FAQs

What is rasagiline mesylate used for?

Rasagiline mesylate is used primarily in the treatment of Parkinson's disease, particularly for its neuroprotective properties and as an adjunct to levodopa therapy.

What are the key segments of the rasagiline mesylate market?

The market is segmented by type (above 98%, above 99%), application (tablets, others), and geography (North America, Europe, APAC, South America, Middle East and Africa).

Who are the major players in the rasagiline mesylate market?

Major players include Jai Radhe Sales, Mylan, Beijing Mesochem Technology, Tai Heng Industry Co. Ltd, Glenmark Pharmaceuticals, and several others.

What are the growth projections for the rasagiline mesylate market?

The market is projected to grow significantly from 2023 to 2031, with a substantial increase in revenue expected during this period.

What are the main drivers of the rasagiline mesylate market growth?

Key drivers include the rising prevalence of Parkinson's disease, advancements in healthcare infrastructure, and regulatory approvals.

What challenges does the rasagiline mesylate market face?

Challenges include competition from generic drugs, potential side effects, and economic factors such as changes in healthcare policies.

Sources

1. Market Research Intellect, "Rasagiline Mesylate API Market Size, Scope And Forecast Report," October 2024.
2. PubMed, "Rasagiline mesylate, a new MAO-B inhibitor for the treatment of Parkinson's disease," 2001.
3. Dataintelo, "Global Rasagiline Mesylate Tablets Sales Market," February 2022.
4. Market Research Reports, "Global Rasagiline Mesylate Tablets Market Growth 2024-2030," October 2024.
5. Patsnap, "Pramipexole Dihydrochloride Hydrate/Rasagiline Mesylate," April 2024.