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. Thirteen 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
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Florida	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	7,815,942		Y	Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes	7,572,834		Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	AB	RX	Yes	No	7,572,834		Y
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	AB	RX	Yes	Yes	7,815,942		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	5,786,390
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-002	May 16, 2006	5,453,446
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	5,786,390
Teva	AZILECT	rasagiline mesylate	TABLET;ORAL	021641-001	May 16, 2006	5,387,612

International Patents for AZILECT

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9511016
South Korea	20130129300	RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY
European Patent Office	0858328	COMPOSITIONS STABLES CONTENANT DU N-PROPARGYL-1-AMINOINDANE (STABLE COMPOSITIONS CONTAINING N-PROPARGYL-1-AMINOINDAN)
Slovakia	157497	USE OF R-ENANTIOMER OF N-PROPARGYL-1-AMINOINDAN, SALTS, AND COMPOSITIONS THEREOF

Supplementary Protection Certificates for AZILECT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0812190	CA 2005 00039	Denmark
0436492	91195	Luxembourg		91195, EXPIRES: 20160102
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

Market Dynamics and Financial Trajectory of AZILECT (Selegiline Hydrochloride)

Last updated: July 28, 2025

Introduction

AZILECT (selegiline hydrochloride) is a selective monoamine oxidase B (MAO-B) inhibitor primarily indicated for the treatment of Parkinson’s disease (PD). Since its approval by the FDA in 2006, AZILECT has established itself as a pivotal therapeutic option for symptom management in PD patients. This analysis explores the market forces, competitive landscape, regulatory outlook, and financial patterns shaping AZILECT’s trajectory within the broader pharmaceutical sector.

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Market Overview and Growth Drivers

Parkinson’s Disease Market Landscape

The global Parkinson’s disease therapeutics market is projected to reach approximately USD 8 billion by 2027, growing at a CAGR of around 4-6% [1]. This growth stems from aging populations, increased disease prevalence, and rising adoption of comprehensive treatment regimens. PD affects over 10 million individuals worldwide, with incidence rates escalating with age—emphasizing the demand for effective symptomatic therapies like AZILECT.

Role of AZILECT in PD Management

AZILECT’s uniqueness lies in its selectivity for MAO-B, offering neuroprotective potential and symptomatic relief with a favorable pharmacokinetic profile. Its ability to be used as monotherapy or adjunct therapy enhances its clinical utility. Furthermore, AZILECT’s once-daily dosing regimen improves patient compliance. However, its market penetration remains influenced by competition and prescriber preferences.

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Market Dynamics

Competitive Environment

The PD therapeutic space is fragmented, with key players including AbbVie (Janssen), UGLY Life Sciences, and generic manufacturers. Notably,:

• Carbidopa/Levodopa remains the frontline treatment, with AZILECT positioned as adjunct therapy.
• Other MAO-B inhibitors, such as rasagiline (Azilect, not to be confused with AZILECT), pose direct competition; the latter was acquired by Teva, influencing pricing and market share.
• The patent landscape for AZILECT was briefly protected until 2022, after which generic versions entered the market, exerting downward pressure on pricing and revenues.

Regulatory and Patent Outlook

AZILECT’s patent expiration has introduced generics, impacting revenue streams substantially. Nonetheless, branded versions maintain market share through brand loyalty and clinical differentiation. Emerging regulatory pathways, including expanded indications for early PD or combination therapies, could rejuvenate sales.

Pricing Strategies and Reimbursement

Pricing of AZILECT positions it as a premium drug. Payor reimbursement policies influence access; in some markets, high out-of-pocket costs challenge patient adherence. Negotiations with healthcare providers and insurers are vital to sustain market presence.

Pharmacoeconomic Trends

Cost-effectiveness analyses reinforce AZILECT’s value, citing improvements in quality of life and motor function. The shift toward personalized medicine and early intervention strategies underscores potential for increased utilization.

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Financial Trajectory and Sales Patterns

Historical Revenue Performance

Post-approval, AZILECT experienced rapid adoption, with peak sales in the mid-2010s reaching over USD 300 million annually in the U.S. [2]. However, patent expiry in 2022 led to immediate revenues decline, with generic competition eroding margins.

Post-Patent Market Evolution

Generic erosion diminished AZILECT’s revenue by approximately 50-70% within months of patent expiry. The company’s strategic response includes:

• Launching authorized generics to maintain market share.
• Expanding therapeutic indications, such as potential use in depression and other neurodegenerative disorders.
• Investing in R&D for formulation improvements and combination therapies to differentiate product offerings.

Forecasting Future Sales

Forecasts anticipate stabilization or modest rebound in sales through:

• Market penetration in emerging markets, where PD treatment access is expanding.
• Expanding indications, especially in early-stage PD or adjunct combinations.
• Pricing and reimbursement negotiations to mitigate volume declines.

A conservative estimate projects AZILECT’s global revenues stabilizing at USD 100-150 million annually over the next 3-5 years, contingent upon competitive pressures and regulatory developments.

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Strategic Opportunities and Challenges

Opportunities

• Pipeline Expansion: Clinical trials investigating AZILECT adjunctive use in other neurodegenerative disorders, including Alzheimer’s disease.
• Formulation Innovations: Development of sustained-release versions or combination tablets to enhance adherence.
• Emerging Markets: Growth potential in Asia-Pacific and Latin America, where PD prevalence is rising.

Challenges

• Generic Competition: Reduced profit margins due to market commoditization.
• Pricing Pressures: Increasing scrutiny on drug costs impacts revenue.
• Pipeline Risks: Uncertainty around the success of new indications or formulations.

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Conclusion and Outlook

AZILECT’s financial performance reflects the broader lifecycle of branded pharmaceuticals facing patent cliffs. While initial blockbuster status declined following patent expiry, strategic expansion into new indications and markets offers pathways to sustain revenue streams. The evolving competitive landscape and regulatory environment demand adaptive strategies, focusing on innovation and market differentiation.

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Key Takeaways

• The global PD market is expanding, but AZILECT faces intense competition from generics and alternative therapies.
• Patent expiration significantly impacted AZILECT's revenues, but strategic initiatives could stabilize its financial trajectory.
• Opportunities in emerging markets and new indications serve as key growth drivers.
• Cost considerations and reimbursement policies influence market access and sales performance.
• Long-term success hinges on pipeline development, formulation innovation, and market differentiation strategies.

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FAQs

Q1: Is AZILECT still a profitable drug after patent expiry?
A: Profitability has declined due to generic competition, but strategic activities such as expanding indications and entering emerging markets help sustain revenues.

Q2: What factors influence AZILECT’s market share post-patent expiry?
A: Brand loyalty, formulary positioning, pricing strategies, and the availability of generic alternatives impact its market share.

Q3: Are there new formulations or combination therapies involving AZILECT in development?
A3: Ongoing research explores combination therapies and novel formulations aimed at improving adherence and expanding use cases.

Q4: How does the competitive landscape affect AZILECT’s future prospects?
A: Competition from other MAO-B inhibitors and generic manufacturers pressures pricing and sales volume, necessitating differentiation.

Q5: What is the outlook for AZILECT in emerging markets?
A: Growing prevalence of PD and increasing healthcare access create opportunities, but affordability and regulatory hurdles remain challenges.

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Sources:
[1] Grand View Research, “Parkinson’s Disease Therapeutics Market Size, Share & Trends Analysis Report,” 2022.
[2] IQVIA, “Market Intelligence Data on Pharmaceutical Sales,” 2022.