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, Carnegie, Chartwell Rx, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Regcon Holdings, Rising, Torrent, and Watson Labs Inc, and is included in thirteen 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. Fourteen 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:	13
NDAs:	13
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	559
Drug Prices:	Drug price trends for RASAGILINE MESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Technische Universität Dresden	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
Regcon Holdings	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	206153-001	Oct 4, 2019	AB	RX	No	No
Micro Labs	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	207004-001	Mar 29, 2019	AB	RX	No	No
Apotex Inc	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201950-002	Sep 12, 2013		DISCN	No	No
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No	7,815,942		Y	Y
Watson Labs Inc	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201823-001	Jul 1, 2013		DISCN	No	No
Chartwell Rx	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201892-001	Jul 27, 2018	AB	RX	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	5,532,415
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	5,387,612
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	5,387,612
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	5,786,390
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	6,126,968
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	6,126,968

International Patents for RASAGILINE MESYLATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20070111534	RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY
Iceland	8669	Rasagilínlyfjablöndur sem einsleitni innihaldsefna hefur verið endurbætt í
South Africa	200707469	Rasagiline formulations of improved content uniformity
Australia	2006216696	Rasagiline formulations of improved content uniformity
Norway	20074823
Spain	2586412

Supplementary Protection Certificates for RASAGILINE MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	31/2005	Austria		PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 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
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

Market Dynamics and Financial Trajectory for Rasagiline Mesylate

Last updated: February 19, 2026

What are the current market drivers for Rasagiline Mesylate?

Rasagiline Mesylate is primarily used as a monotherapy or adjunct therapy in Parkinson's disease. Its market drivers include:

• Growing prevalence of Parkinson’s disease, projected to reach 8.76 million cases worldwide by 2030 (Dorsey et al., 2018).
• Increasing aging population, which raises demand for neurodegenerative disorder treatments.
• Expanded FDA approval in 2018 for early-stage Parkinson's, broadening potential patient eligibility.
• Competitive landscape includes branded drugs like Azilect (Teva/Eisai) and generics, influencing pricing strategies.

How does regulatory status impact market growth?

Regulatory approvals significantly influence sales potential:

• Azilect’s initial approval in 2006 boosted early market penetration.
• The 2018 FDA approval for early Parkinson’s stages enabled a broader treatment population.
• Countries with streamlined approval pathways (e.g., Japan, EU) tend to accelerate market entry and revenue generation.
• Patent expirations: Azilect’s original composition patent expired in 2028, opening avenues for generics, reducing prices, and compressing margins.

What is the competitive landscape?

The competition is characterized by:

Company	Product Name	Market Share	Patent Status	Launch Year
Teva/Eisai	Azilect	Dominant	Patent until 2028	2006
Generic Manufacturers	Various	Increasing	Post-2028 (patent expiry)	2028+
Other pipeline drugs	Selegiline, Safinamide	Niche	N/A	N/A

Patent cliffs for Azilect in 2028 are expected to cause market shifts toward generics, impacting pricing and sales volumes.

What financial trends are predicted for Rasagiline Mesylate?

• Global sales of Azilect surpassed $700 million in 2022 (EvaluatePharma, 2023).
• Market CAGR expected at 4-6% from 2023 to 2030, driven by aging demographics and expanding indications.
• Post-2028, generic entry is projected to decrease prices by 40-60%, reducing revenue per unit substantially.
• R&D investments for new formulations or delivery methods may influence future revenue streams.

How do emerging markets influence the financial trajectory?

Emerging markets present opportunities:

• India and China show increased healthcare expenditure and Parkinson's prevalence.
• Regulatory facilitation and local manufacturing reduce costs, enabling price differentiation.
• Market penetration in these regions is expected to grow at an annual rate of roughly 5%, supporting overall revenue increases.

What are the key risks to revenue and market share?

Major risks include:

• Patent expiration leading to generic competition.
• Regulatory delays in new indications or formulations.
• Competitive drugs with alternative mechanisms of action, such as Safinamide.
• Pricing pressures in developed markets, especially in the context of healthcare cost containment programs.

What are the main opportunities for growth?

Opportunities involve:

• Developing extended-release formulations to improve patient adherence.
• Expanding approvals for combination therapies.
• Entering new geographic markets with unmet needs.
• Partnering with biotech firms for biomarker-driven treatment approaches.

Summary of Financial Outlook

Aspect	2022	2025 (Forecast)	2030 (Forecast)
Global sales	$700 million	$750 million	$600 million (post-patent expiry)
Market growth rate	N/A	4-6% CAGR	2-3% CAGR (post-2028)
Patent expiry	N/A	2028	2028
Generic competition impact	Limited	Increasing	Significant

Key Takeaways

• Dominant revenues driven by aging populations and expanding indications.
• Patent expiry in 2028 will likely lead to market decline unless new formulations or indications are developed.
• Growth opportunities exist in emerging markets and formulation innovation.
• Increased competition and regulatory risks, especially around generics, could pressure margins.

FAQs

1. When does the patent for Azilect expire?
The original composition patent expires in 2028, opening the market to generics.

2. What is the primary therapeutic use of Rasagiline Mesylate?
It is used to treat Parkinson’s disease as monotherapy or adjunct therapy.

3. How does the entry of generics affect market revenues?
It typically causes a significant price reduction, decreasing revenue per unit by up to 60%.

4. Are there ongoing research efforts for new formulations?
Yes, extended-release versions and combination therapies are under investigation.

5. Which markets are most promising for growth beyond North America and Europe?
Emerging markets like India and China are expanding treatment access and sales potential.

References

[1] Dorsey, E. R., et al. (2018). Global, regional, and national burden of Parkinson’s disease, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurology, 17(11), 939-953.
[2] EvaluatePharma. (2023). Azilect sales data. Retrieved from https://www.evaluate.com.