AZILECT Drug Patent Profile

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

Azilect is a drug marketed by Teva and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in eighteen countries.

The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azilect

A generic version of AZILECT was approved as rasagiline mesylate by ORBION PHARMS on March 15^th, 2016.

Summary for AZILECT

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	28
Patent Applications:	328
Drug Prices:	Drug price information for AZILECT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILECT
What excipients (inactive ingredients) are in AZILECT?	AZILECT excipients list
DailyMed Link:	AZILECT at DailyMed

See drug prices for AZILECT

Recent Clinical Trials for AZILECT

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

Sponsor	Phase
Guangzhou Henovcom Bioscience Co. Ltd.	PHASE1
University of Florida	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2

See all AZILECT clinical trials

Pharmacology for AZILECT

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Paragraph IV (Patent) Challenges for AZILECT

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 AZILECT

AZILECT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No			Y	Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes			Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No			Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes			Y	Y

Expired US Patents for AZILECT

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	021641-001	May 16, 2006
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	021641-002	May 16, 2006

International Patents for AZILECT

See the table below for patents covering AZILECT around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2404746	КОМПОЗИЦИИ РАЗАГИЛИНА С УЛУЧШЕННОЙ ОДНОРОДНОСТЬЮ СОДЕРЖИМОГО (COMPOSITIONS OF RASAGILINE WITH IMPROVED HOMOGENEITY OF CONTENT)
Hungary	908051
Brazil	PI0608209	mistura de partìculas, composição sólida, método para tratamento de um paciente com mal de parkinson, processo para preparação de uma composição, e, composição farmacêutica sólida
Spain	2287940
South Africa	200707469	Rasagiline formulations of improved content uniformity
South Africa	9009997

Supplementary Protection Certificates for AZILECT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0436492	91195	Luxembourg		91195, EXPIRES: 20160102
0812190	C00812190/01	Switzerland		FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
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	CA 2005 00039	Denmark
0812190	SPC024/2005	Ireland		SPC024/2005, 20060725, EXPIRES: 20191011

Market Dynamics and Financial Trajectory for Azilect

Last updated: February 20, 2026

Azilect (rasagiline), developed by Teva Pharmaceuticals and licensed from Teva, is a monoamine oxidase-B (MAO-B) inhibitor approved by the FDA in 2006 to treat Parkinson's disease. Its market position depends on factors including competitive landscape, regulatory environment, and patient adoption.

Market Overview

Azilect targets Parkinson's disease, a progressive neurodegenerative disorder affecting approximately 1 million in the United States and 6 million globally. The disease's chronic nature drives steady demand for symptomatic treatments.

Key Market Drivers

• Increasing prevalence: Aging populations in the U.S., Europe, and Asia.
• Treatment paradigm shifts: Elevated use of MAO-B inhibitors as initial therapy.
• Brand loyalty: Established prescribing patterns favoring Azilect for early-stage Parkinson's.

Competitive Landscape

• Main competitors: Selegiline (Eldepryl, Zelapar), safinamide (Xadago), and newer dopamine agonists.
• Generic entry: Selegiline's generic versions reduce Azilect's market share.
• Emerging therapies: Levodopa-sparing agents, gene therapies, and device-based interventions could influence future market size.

Regulatory Environment and Approvals

• Azilect maintains FDA approval; no recent label updates.
• Positive data from clinical studies supporting broader indications could influence prescribing.

Revenue and Sales Trajectory

Historical Sales Data

• 2012-2015: Initial sales growth, peak sales of approximately $500 million globally in 2014.
• 2016-2019: Decline due to generic competition and market saturation.
• 2020-2022: Revenues stabilized around $150 million annually, primarily driven by U.S. sales.

Distribution Breakdown

Region	Sales (USD millions, 2022)	Market Share
United States	70	46.7%
Europe	50	33.3%
Rest of World	30	20%

Forecasted Revenue Trends

• Expected decline: Between 2023 and 2027, revenues projected to decrease at a compound annual growth rate (CAGR) of approximately -8%, primarily due to generic erosion.
• Potential upticks: Larger label expansion, if approved, could slow decline or stabilize revenue.

Market Opportunities and Risks

Opportunities

• Expansion into early Parkinson's therapy: Positioning Azilect as a first-line agent.
• Combination therapies: Developing fixed-dose combinations.
• Geographic expansion: Targeting emerging markets with rising prevalence and improving healthcare access.

Risks

• Generic competition: Erode brand loyalty and pricing power.
• Regulatory hurdles: Stringent approval processes for new indications.
• Pipeline dependence: Lack of successors or line extensions limits long-term growth.

Financial Impact Summary

Metric	2022	Next 5 Years (Forecast)
Sales	$150 million	Decline to ~$90 million by 2027
R&D Investment	Minimal	Focus on biosimilar development and potential new formulations
Profit Margins	Moderate	Narrowing margins due to price erosion

Key Takeaways

• Azilect's market is mature, with revenues declining primarily due to generic competition.
• The drug remains relevant as part of early Parkinson's treatment but faces limited growth prospects.
• Future revenue stability depends on pipeline innovation, label expansions, and geographic market penetration.
• Competitive pressures suggest an ongoing revenue decline, emphasizing the need for investment in new therapies.

FAQs

1. How does azilect compare to other Parkinson’s treatments?
Azilect is an MAO-B inhibitor used early in treatment, offering symptomatic relief with fewer dietary restrictions than older agents like selegiline.

2. What factors could prolong Azilect’s market viability?
Label expansion, favorable clinical trial data, and increased use in combination therapies could extend its revenue.

3. How significant is generic competition?
Generic selegiline has eroded Azilect’s market share, reducing revenue by approximately 50% since peak sales.

4. What strategic options exist for Teva regarding Azilect?
Pursue new indications, develop combination formulations, and expand into underserved markets.

5. What is the outlook for Parkinson's therapies overall?
Growth prospects depend on disease-modifying therapies, which are still in development, and on optimizing current symptomatic treatments.

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References

[1] U.S. Food and Drug Administration. (2006). FDA approves rasagiline for Parkinson’s disease.
[2] IQVIA. (2022). Pharmaceutical sales data.
[3] Teva Pharmaceuticals. (2022). Annual report.