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. Twelve 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:	3
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	27
Patent Applications:	4,069
Drug Prices:	Drug price information 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
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Florida	Phase 2
Thomas Guttuso

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	021641-002	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
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
South Korea	20130129300	RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY
China	1191481
Israel	244802	פורמולציות של רסאג'ילין בעלות אחידות תוכן משופרת (Rasagiline formulations of improved content uniformity)
World Intellectual Property Organization (WIPO)	9637199
Latvia	12083	N-PROPARGIL-1-AMINOINDANA R-ENANTIOMĒRA, TĀ SĀĻU UN KOMPOZĪCIJU IZMANTOŠANA

Supplementary Protection Certificates for AZILECT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0812190	CA 2005 00039	Denmark
0812190	300205	Netherlands		300205, 20141012, EXPIRES: 20191011
0436492	91195	Luxembourg		91195, EXPIRES: 20160102
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	C00812190/01	Switzerland		FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL

AZILECT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azilect

Introduction

Azilect, a medication containing the active substance rasagiline, is used to treat Parkinson's disease, a progressive brain disorder characterized by shaking, slow movement, and muscle stiffness. Here, we will delve into the market dynamics and financial trajectory of Azilect, exploring its usage, market performance, and financial highlights.

Market Position and Usage

Azilect is authorized for use in the European Union and other regions for the treatment of idiopathic Parkinson's disease, either as monotherapy or as an adjunct to levodopa in patients experiencing end-of-dose fluctuations[1][3].

Monotherapy and Adjunct Therapy

Azilect can be used alone in early-stage Parkinson's disease or in combination with levodopa for patients with later-stage disease. This versatility has helped it maintain a significant presence in the Parkinson's disease treatment market.

Clinical Efficacy

Clinical studies have shown that Azilect is more effective than placebo in improving symptoms of Parkinson's disease. When used alone, it reduces the Unified Parkinson’s Disease Rating Scale (UPDRS) score, indicating an improvement in symptoms. As an add-on to levodopa, it reduces the time spent in the ‘off’ state, enhancing patient mobility and quality of life[1].

Market Challenges

Despite its clinical efficacy, Azilect faced challenges in maintaining sales growth. By June 2011, the growth rate for Azilect had started to decline, partly due to occasional prescribing by Parkinson's disease specialists and increased competition in the market[4].

Revitalizing Sales Growth

To address the decline, strategies were implemented to revitalize sales growth. These efforts likely involved enhanced marketing, educational programs for healthcare professionals, and patient support initiatives. Such strategies are crucial for maintaining market share and driving growth in a competitive pharmaceutical market.

Financial Performance

The financial performance of Azilect is closely tied to the overall financial health of its manufacturers and distributors.

Revenue Growth

In recent years, Azilect has contributed to the revenue growth of its parent company. For instance, in the first half of 2022, Azilect generated revenue of DKK 111 million, which, although not the highest among Lundbeck's products, still contributes to the company's overall revenue[5].

Lundbeck's Financial Highlights

Lundbeck, one of the key companies associated with Azilect, reported an 11% increase in core revenue in the first nine months of 2022 compared to the same period in 2021. While Azilect's revenue is a fraction of Lundbeck's total revenue, it is part of the company's strategic brands that have seen significant growth. The strategic brands grew by 30% in local currencies, driven by strong demand and favorable currency exchange rates[2].

Regional Performance

Azilect's performance varies by region, reflecting different market dynamics and healthcare systems.

United States Market

In the United States, Lundbeck's strategic brands, including Azilect, have shown robust growth. The sales growth in the U.S. market was driven by strong demand and positively impacted by the appreciation of the USD. This indicates that Azilect remains a viable treatment option in the U.S. market for Parkinson's disease[2].

Competitive Landscape

The market for Parkinson's disease treatments is competitive, with several medications available, including levodopa, entacapone, and other MAO-B inhibitors.

Differentiation

Azilect differentiates itself through its selective inhibition of monoamine oxidase type B (MAO-B) at recommended doses, which helps in maintaining dopamine levels in the brain. This differentiation, along with its efficacy in reducing 'off' time in patients with end-of-dose fluctuations, helps it compete effectively in the market[1][3].

Side Effects and Safety Considerations

While Azilect is generally well-tolerated, it has several side effects and safety considerations that can impact its market dynamics.

Common Side Effects

Headache is one of the most common side effects, and other potential side effects include drowsiness, orthostatic hypotension, and dyskinesia. These side effects can influence prescribing decisions and patient compliance[1][3].

Contraindications and Interactions

Azilect is contraindicated with certain medications, such as meperidine, tramadol, and MAO inhibitors, due to the risk of serotonin syndrome. These contraindications and interactions must be carefully managed to ensure patient safety and maintain market trust[3].

Regulatory and Marketing Authorizations

Azilect has received marketing authorizations in several regions, including the European Union.

European Commission Approval

The European Commission granted a marketing authorization for Azilect in 2005, which was renewed in 2010. This approval is based on the Committee for Medicinal Products for Human Use (CHMP) recommendation that Azilect's benefits outweigh its risks for the treatment of Parkinson's disease[1].

Key Takeaways

• Clinical Efficacy: Azilect is effective in treating Parkinson's disease, both as monotherapy and as an adjunct to levodopa.
• Market Challenges: Despite its efficacy, Azilect faced declining sales growth, which required revitalization strategies.
• Financial Performance: Azilect contributes to the revenue growth of its parent company, with notable performance in the U.S. market.
• Competitive Landscape: Azilect competes in a crowded market but differentiates itself through its selective MAO-B inhibition.
• Safety Considerations: The medication has several side effects and contraindications that must be managed carefully.

FAQs

What is Azilect used for?

Azilect is used to treat Parkinson's disease, either as monotherapy or as an adjunct to levodopa in patients experiencing end-of-dose fluctuations.

How does Azilect work?

Azilect works by inhibiting the enzyme monoamine oxidase type B (MAO-B), which breaks down dopamine in the brain, thereby increasing dopamine levels and improving movement and coordination.

What are the common side effects of Azilect?

Common side effects include headache, drowsiness, orthostatic hypotension, and dyskinesia.

Can Azilect be used with other medications?

Azilect has several contraindications and interactions, particularly with medications like meperidine, tramadol, and MAO inhibitors, due to the risk of serotonin syndrome.

How has Azilect's sales growth been in recent years?

Azilect's sales growth had declined by 2011 but has been revitalized through various marketing and educational strategies. It continues to contribute to the revenue growth of its parent company, particularly in the U.S. market.

Sources

1. European Medicines Agency. Azilect | European Medicines Agency (EMA) - Europa.eu.
2. Lundbeck. Lundbeck's sales increased by 11% (+6% in local currencies) to ...
3. RxList. Rasagiline: Side Effects, Uses, Dosage, Interactions, Warnings - RxList.
4. PMEA Awards. Revitalising the Sales Growth for Azilect - PMEA Awards.
5. Lundbeck. Financial report for the period January 1 to June 30, 2022 - Lundbeck.