SELEGILINE - Generic Drug Details

What are the generic sources for selegiline and what is the scope of freedom to operate?

Selegiline is the generic ingredient in four branded drugs marketed by Somerset, 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 seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for selegiline. One supplier is listed for this compound.

Summary for SELEGILINE

US Patents:	0
Tradenames:	4
Applicants:	14
NDAs:	17
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	38
Patent Applications:	7,807
Drug Prices:	Drug price trends for SELEGILINE
What excipients (inactive ingredients) are in SELEGILINE?	SELEGILINE excipients list
DailyMed Link:	SELEGILINE at DailyMed

See drug prices for SELEGILINE

Recent Clinical Trials for SELEGILINE

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

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

See all SELEGILINE clinical trials

Pharmacology for SELEGILINE

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

Medical Subject Heading (MeSH) Categories for SELEGILINE

Antiparkinson Agents

Monoamine Oxidase Inhibitors

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for SELEGILINE

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

US Patents and Regulatory Information for SELEGILINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dash Pharms Natco	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074866-001	Nov 26, 1997		DISCN	No	No
Cosette	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074756-001	Nov 25, 1998		DISCN	No	No
Norvium Bioscience	ELDEPRYL	selegiline hydrochloride	CAPSULE;ORAL	020647-001	May 15, 1996		DISCN	Yes	No
Cosette	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074744-001	Jan 27, 1997		DISCN	No	No
Mlv	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074672-001	Apr 1, 1997	AB	RX	No	No
Apotex	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075321-001	Dec 4, 1998	AB	RX	No	Yes

Expired US Patents for SELEGILINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-003	Feb 27, 2006
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-002	Feb 27, 2006
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-003	Feb 27, 2006
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-001	Feb 27, 2006
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-002	Feb 27, 2006
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-003	Feb 27, 2006

SELEGILINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Selegiline

Introduction

Selegiline, a selective and irreversible inhibitor of monoamine oxidase B (MAO-B), has been a crucial medication in the treatment of Parkinson's disease and, to a lesser extent, depression. Here, we delve into the market dynamics and financial trajectory of selegiline, highlighting key events, economic impacts, and regulatory considerations.

Discovery and Approval

Selegiline was first discovered in the 1960s by József Knoll and his colleagues at Chinoin Pharmaceutical Company in Hungary. It was initially introduced for medical use in Hungary in 1977, later approved in the United Kingdom in 1982, and in the United States in 1989[4].

Market Share and Consolidation

Prior to the 2007 shortage, the market for generic selegiline saw significant consolidation. The total prescriptions filled for generic selegiline decreased by 42%, with the supply consolidating into one major company, Apotex Inc., whose market share increased from 41% to 83%[1][3].

The 2007 Shortage

In September 2007, a shortage of generic selegiline occurred, leading to significant market disruptions. During the first four months of the shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected, while other manufacturers filled 7,400 more than projected, resulting in a net shortage of 3,100 prescriptions. This shortage led to an increase in the number of branded selegiline capsules filled, with 1,800 more than projected, and 1,300 prescriptions for generic selegiline that were not refilled or substituted[1].

Economic Impact of the Shortage

The societal cost of substituting generic selegiline with branded capsules during the shortage was substantial, amounting to $75,000 over the first four months. This economic burden underscores the financial implications of drug shortages on both patients and the healthcare system[1].

Pricing and Accessibility

The cost of selegiline can be a significant barrier for patients. During the shortage, the shift to more expensive branded alternatives highlighted the financial strain on patients who could not afford the higher-priced options. This issue is not unique to selegiline; it reflects broader challenges in the pharmaceutical market where generic drug shortages can lead to increased healthcare costs[1][2].

Regulatory Scrutiny

The 2007 shortage and subsequent economic impact have called for heightened regulatory scrutiny of the generic drug industry. The consolidation of the market into fewer players increases the risk of shortages, emphasizing the need for robust regulatory measures to ensure a stable supply of essential medications[1].

Therapeutic Use and Efficacy

Selegiline is primarily used in the treatment of Parkinson's disease, both as monotherapy and in combination with levodopa. The MONOCOMB study demonstrated that selegiline significantly delayed the need for levodopa therapy and improved symptom status and disability in patients with Parkinson's disease. It also showed that selegiline, when used as an adjunct to levodopa, allowed for a lower total consumption of levodopa and delayed the emergence of motor fluctuations[5].

Financial Trajectory

The financial trajectory of selegiline is influenced by its therapeutic efficacy, market demand, and regulatory environment. The drug's ability to delay the progression of Parkinson's disease and its levodopa-sparing qualities contribute to its economic value. However, the financial impact of shortages and the shift to more expensive alternatives can significantly affect the overall financial performance of the drug in the market.

Generic and Branded Forms

Selegiline is available in various forms, including conventional oral tablets, orally disintegrating tablets (ODT), and transdermal patches. While generic versions of the conventional oral form are available, the ODT and transdermal patch forms are not, which can affect pricing and accessibility. The ODT and transdermal forms were approved in the United States in 2006 and in the European Union in 2010, respectively[4].

Future Outlook

Given the ongoing consolidation in the generics drug industry, the risk of future shortages remains. This necessitates continuous monitoring and regulatory oversight to ensure a stable supply of selegiline. Additionally, ongoing research into the use of selegiline in other conditions, such as depression, may expand its market and financial potential[1][4].

Key Takeaways

• Market Consolidation: The generic selegiline market saw significant consolidation, increasing the risk of shortages.
• Economic Impact: The 2007 shortage led to a substantial economic burden due to the substitution with more expensive branded alternatives.
• Regulatory Scrutiny: Heightened regulatory oversight is necessary to prevent future shortages.
• Therapeutic Efficacy: Selegiline is effective in treating Parkinson's disease and has levodopa-sparing qualities.
• Financial Trajectory: The drug's financial performance is influenced by its therapeutic efficacy, market demand, and regulatory environment.

FAQs

What is selegiline used for?

Selegiline is primarily used in the treatment of Parkinson's disease, both as monotherapy and in combination with levodopa. It is also used in the treatment of depression, particularly in the form of a transdermal patch[4].

What happened during the 2007 selegiline shortage?

During the 2007 shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected, leading to a net shortage of 3,100 prescriptions. This resulted in increased use of more expensive branded alternatives and a societal cost of $75,000 over the first four months[1].

How does selegiline affect the progression of Parkinson's disease?

Selegiline significantly delays the need for levodopa therapy and improves symptom status and disability in patients with Parkinson's disease. It also delays the emergence of motor fluctuations when used as an adjunct to levodopa[5].

What are the different forms of selegiline available?

Selegiline is available in conventional oral tablets, orally disintegrating tablets (ODT), and transdermal patches. However, generic versions are only available for the conventional oral form[4].

What are the potential future challenges for selegiline in the market?

Future challenges include the risk of shortages due to market consolidation and the need for continuous regulatory oversight to ensure a stable supply of the drug[1].

Sources

1. Selegiline shortage: Causes and costs of a generic drug shortage - PubMed
2. Adherence to Pharmacological Smoking Cessation Interventions - Oxford Academic
3. Drug selegiline r deprenyl: Topics by Science.gov - Science.gov
4. Selegiline - Wikipedia
5. Use of Selegiline as Monotherapy and in Combination with Levodopa in the Management of Parkinson's Disease: Perspectives from the MONOCOMB Study - Cambridge University Press