Selegiline hydrochloride - Generic Drug Details

What are the generic sources for selegiline hydrochloride and what is the scope of patent protection?

Selegiline hydrochloride is the generic ingredient in three branded drugs marketed by Norvium Bioscience, Apotex, Lannett Co Inc, Novitium Pharma, Rising, Bausch, Apotex Inc, Chartwell Molecules, Cosette, Dash Pharms Natco, G And W Labs Inc, Kenton, and MLV, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for selegiline hydrochloride. Eleven suppliers are listed for this compound.

Summary for selegiline hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	16
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	38
Patent Applications:	1,005
What excipients (inactive ingredients) are in selegiline hydrochloride?	selegiline hydrochloride excipients list
DailyMed Link:	selegiline hydrochloride at DailyMed

Recent Clinical Trials for selegiline hydrochloride

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

Sponsor	Phase
University of Ibadan	Phase 1/Phase 2
E-Group ICT Software Informatikai Zrt.	Phase 2
László Mangel	Phase 2

See all selegiline hydrochloride clinical trials

Pharmacology for selegiline hydrochloride

Drug Class	Monoamine Oxidase Inhibitor Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for selegiline hydrochloride

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

US Patents and Regulatory Information for selegiline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mlv	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074672-001	Apr 1, 1997	AB	RX	No	No
Kenton	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074912-001	Apr 30, 1998		DISCN	No	No
Novitium Pharma	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075352-001	Nov 30, 1998	AB	RX	No	No
G And W Labs Inc	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074537-001	Aug 2, 1996		DISCN	No	No
Rising	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	206803-001	Apr 2, 2019	AB	RX	No	No
Norvium Bioscience	ELDEPRYL	selegiline hydrochloride	CAPSULE;ORAL	020647-001	May 15, 1996		DISCN	Yes	No

Expired US Patents for selegiline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006

Selegiline hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Selegiline Hydrochloride

Introduction

Selegiline hydrochloride, a medication primarily used in the treatment of Parkinson's disease, has a complex market landscape influenced by various factors including demand, supply, regulatory environments, and economic conditions. This article delves into the market dynamics and financial trajectory of selegiline hydrochloride, providing insights into its current state and future projections.

Market Size and Share

The global selegiline hydrochloride market has been growing steadily, driven by the increasing prevalence of Parkinson's disease and the need for effective treatment options. According to recent reports, the market size is expected to expand significantly from 2023 to 2030, with a notable Compound Annual Growth Rate (CAGR)[4].

Application and Usage

Selegiline hydrochloride is used in combination with levodopa or levodopa and carbidopa to enhance the effects of these medications in treating Parkinson's disease. It is available in various dosage forms, including tablets, disintegrating tablets, and capsules. The versatility in dosage forms caters to different patient needs, contributing to its market growth[2].

Regional Market Analysis

The North American market for selegiline hydrochloride is particularly robust, with significant growth anticipated over the next few years. This region's market is expected to increase from a substantial figure in 2023 to a higher figure by 2030, driven by advanced healthcare infrastructure and high demand for Parkinson's disease treatments[4].

Supply Chain and Shortages

Historically, the selegiline hydrochloride market has faced challenges due to supply chain disruptions. In 2007, a shortage of generic selegiline occurred, leading to a significant economic impact. During this period, the number of prescriptions filled by the primary supplier decreased, while other manufacturers and branded alternatives saw an increase in prescriptions. This shortage highlighted the economic and health implications of generic drug shortages and the need for robust supply chain management[3].

Economic Impact

The economic impact of selegiline hydrochloride shortages can be substantial. For instance, during the 2007 shortage, the societal cost of substituting generic selegiline with branded capsules was estimated at $75,000 over the first four months. Such shortages not only affect patients financially but also compromise their access to essential medications[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics of selegiline hydrochloride. Regulatory scrutiny, especially in the generic drug industry, is essential to prevent shortages and ensure consistent supply. Heightened regulatory oversight can help mitigate the risks associated with market consolidation and supply chain disruptions[3].

Competitive Landscape

The competitive landscape of the selegiline hydrochloride market is characterized by a mix of generic and branded products. The market is dominated by a few key players, with Apotex Inc. being a significant supplier in the past. The consolidation of market share among fewer companies can lead to vulnerabilities in the supply chain, emphasizing the need for diverse and reliable manufacturers[3].

Pricing and Affordability

The pricing of selegiline hydrochloride is a critical factor influencing its market dynamics. Generic versions of the drug are generally more affordable than branded alternatives, making them more accessible to a broader patient population. However, during shortages, patients may be forced to switch to more expensive branded options, increasing the financial burden on them and the healthcare system[3].

Side Effects and Safety Profile

While selegiline hydrochloride is effective in treating Parkinson's disease, it comes with a range of potential side effects. These include dry mouth, dizziness, and unusual changes in behavior such as compulsive eating or gambling. The safety profile of the drug necessitates careful monitoring and adherence to prescribed dosages to minimize adverse effects[2].

Patient Compliance and Adherence

Patient compliance and adherence to selegiline hydrochloride treatment are crucial for its effectiveness. Factors such as ease of administration, side effect management, and patient education play significant roles in ensuring that patients continue their treatment regimens without interruption. Healthcare providers must emphasize the importance of gradual dose reduction if the medication needs to be stopped to avoid withdrawal symptoms[2].

Future Projections

Looking ahead, the selegiline hydrochloride market is expected to continue its growth trajectory. Advances in healthcare technology, increasing awareness of Parkinson's disease, and the development of new dosage forms are likely to drive market expansion. However, ongoing challenges such as supply chain vulnerabilities and regulatory compliance must be addressed to ensure a stable and reliable market[4].

Key Takeaways

• Market Growth: The global selegiline hydrochloride market is projected to grow significantly from 2023 to 2030.
• Regional Focus: The North American market is a key driver of this growth.
• Supply Chain: Historical shortages highlight the need for robust supply chain management.
• Economic Impact: Shortages can result in significant economic costs and compromised patient access.
• Regulatory Environment: Strong regulatory oversight is essential to prevent shortages and ensure market stability.
• Competitive Landscape: Market consolidation among fewer companies can lead to supply chain vulnerabilities.
• Pricing and Affordability: Generic versions are more affordable, but shortages can force patients to more expensive alternatives.

FAQs

What is selegiline hydrochloride used for?

Selegiline hydrochloride is used in combination with levodopa or levodopa and carbidopa to treat Parkinson's disease, helping to increase and extend the effects of levodopa and potentially slowing the progress of the disease[2].

What are the common side effects of selegiline hydrochloride?

Common side effects include dry mouth, dizziness, and unusual changes in behavior such as compulsive eating or gambling. Other side effects can include dry skin, runny or stuffy nose, and muscle aches[2].

Can selegiline hydrochloride be taken during breastfeeding?

There are no adequate studies to determine the infant risk when using selegiline hydrochloride during breastfeeding. Patients should weigh the potential benefits against the potential risks before taking this medication while breastfeeding[2].

What happened during the 2007 selegiline hydrochloride shortage?

The 2007 shortage led to a significant decrease in prescriptions filled by the primary supplier, Apotex Inc., and an increase in prescriptions for branded alternatives. This resulted in a substantial economic impact, with a societal cost of $75,000 over the first four months[3].

How does the regulatory environment impact the selegiline hydrochloride market?

The regulatory environment is crucial in preventing shortages and ensuring consistent supply. Heightened regulatory oversight can help mitigate the risks associated with market consolidation and supply chain disruptions[3].

Sources

1. Biospace: Selegiline Hydrochloride Market Size, Share, Trends, and Forecast 2022 to 2030.
2. Mayo Clinic: Selegiline (oral route) - Mayo Clinic.
3. PubMed: Selegiline shortage: Causes and costs of a generic drug shortage.
4. Valuates Reports: Global Selegiline Hydrochloride Market Research Report 2024.