MECAMYLAMINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for mecamylamine hydrochloride and what is the scope of freedom to operate?

Mecamylamine hydrochloride is the generic ingredient in two branded drugs marketed by Targacept and Lgm Pharma, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for mecamylamine hydrochloride. Two suppliers are listed for this compound.

Summary for MECAMYLAMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	31
Patent Applications:	764
What excipients (inactive ingredients) are in MECAMYLAMINE HYDROCHLORIDE?	MECAMYLAMINE HYDROCHLORIDE excipients list
DailyMed Link:	MECAMYLAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MECAMYLAMINE HYDROCHLORIDE

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

Sponsor	Phase
Vanderbilt University Medical Center	Early Phase 1
Wayne State University	Phase 4
AstraZeneca	Phase 2

See all MECAMYLAMINE HYDROCHLORIDE clinical trials

Pharmacology for MECAMYLAMINE HYDROCHLORIDE

Drug Class	Autonomic Ganglionic Blocker
Physiological Effect	Decreased Autonomic Ganglionic Activity

Medical Subject Heading (MeSH) Categories for MECAMYLAMINE HYDROCHLORIDE

Antihypertensive Agents

Ganglionic Blockers

Nicotinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MECAMYLAMINE HYDROCHLORIDE

C02BB	Secondary and tertiary amines
C02B	ANTIADRENERGIC AGENTS, GANGLION-BLOCKING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

US Patents and Regulatory Information for MECAMYLAMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lgm Pharma	MECAMYLAMINE HYDROCHLORIDE	mecamylamine hydrochloride	TABLET;ORAL	204054-001	Mar 19, 2013		RX	No	Yes
Targacept	INVERSINE	mecamylamine hydrochloride	TABLET;ORAL	010251-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

MECAMYLAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mecamylamine Hydrochloride

Introduction

Mecamylamine hydrochloride, a non-competitive nicotinic acetylcholine receptor antagonist, has a complex and evolving market history. Initially introduced as an antihypertensive agent, its uses and market presence have undergone significant changes over the years.

Historical Market Presence

Mecamylamine hydrochloride was first brought to market by Merck & Co. in the 1950s as an antihypertensive drug under the brand names Inversine and Vecamyl. Over the decades, the drug's ownership changed hands several times. In 1996, Merck sold the asset to Layton Bioscience, which was later acquired by Targacept in 2002. Targacept voluntarily withdrew mecamylamine from the market in 2009, only for it to be reintroduced in 2013 by Manchester Pharmaceuticals. Subsequently, Retrophin acquired Manchester in 2014, and after Martin Shkreli's departure from Retrophin, Turing Pharmaceuticals acquired the rights to mecamylamine[1].

Current Market Status

The current market status of mecamylamine hydrochloride is characterized by its niche applications and limited but diverse therapeutic uses. Here are some key points:

Therapeutic Applications

• Antihypertensive Use: Although initially marketed for hypertension, its use in this area has declined due to the availability of more targeted and safer alternatives.
• Nicotine Dependence: It is now more widely used to help people stop smoking tobacco by blocking α3β4 nicotinic receptors in the brain[1][3].
• Autonomic Dysreflexia and Tourette Syndrome: It is used in treating autonomic dysreflexia and has shown efficacy in providing sustained relief from tics in Tourette syndrome when other agents have failed[1][3].
• Depression: Despite promising Phase II trials, mecamylamine (TC-5214) did not meet primary goals in Phase III trials as an augmentation therapy for major depression[1].

Market Size and Growth

The global market for mecamylamine hydrochloride is relatively small compared to other pharmaceuticals, primarily due to its specialized use cases. However, there is potential for growth as research continues to explore new therapeutic applications. The market size and growth are influenced by the increasing need for effective treatments for nicotine dependence, neuropsychiatric disorders, and other conditions where mecamylamine shows promise[4].

Financial Trajectory

The financial trajectory of mecamylamine hydrochloride is marked by periods of significant change and fluctuation:

Revenue Fluctuations

• The drug's revenue has seen fluctuations due to its withdrawal and re-introduction to the market. The voluntary withdrawal in 2009 led to a significant drop in revenue, which was partially recovered when the drug was re-marketed in 2013[1].
• The acquisition by Turing Pharmaceuticals, known for its controversial pricing strategies, may have impacted the drug's pricing and revenue, although specific financial details are not publicly disclosed.

Research and Development Costs

• The ongoing research into new therapeutic applications, such as depression and substance dependencies, incurs substantial costs. These costs are shared among the involved pharmaceutical companies, including Targacept and AstraZeneca, which have been funding clinical trials for mecamylamine[1][3].

Pricing Strategies

• The pricing of mecamylamine hydrochloride has been a subject of controversy, particularly after Turing Pharmaceuticals acquired the rights. The company's history of significantly increasing drug prices could impact the financial trajectory and accessibility of the drug[1].

Market Dynamics

Competitive Landscape

The competitive landscape for mecamylamine hydrochloride is relatively niche, with few direct competitors due to its specific mechanism of action and therapeutic uses. However, other treatments for nicotine dependence and neuropsychiatric disorders pose indirect competition.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of mecamylamine hydrochloride. Changes in regulatory policies and the approval process for new therapeutic applications can significantly impact the drug's market presence and financial performance.

Patient Demand

Patient demand is another critical factor. The ongoing efforts to reduce smoking and treat related health issues, as highlighted by the U.S. Department of Health and Human Services, create a steady demand for effective smoking cessation treatments like mecamylamine hydrochloride[5].

Future Outlook

Potential New Applications

Research into new therapeutic applications, such as treating major depression and other neuropsychiatric disorders, holds promise for expanding the market for mecamylamine hydrochloride. However, the failure of Phase III trials for depression treatment has tempered some of this optimism[1][3].

Market Expansion

The global market for mecamylamine hydrochloride could expand if the drug gains approval for additional indications or if its use becomes more widespread in existing markets.

Key Takeaways

• Historical Market Presence: Mecamylamine hydrochloride has undergone multiple changes in ownership and market presence since its introduction.
• Current Market Status: The drug is used in niche therapeutic areas, including nicotine dependence and autonomic dysreflexia.
• Financial Trajectory: Revenue has fluctuated due to market withdrawal and re-introduction, with significant costs associated with research and development.
• Market Dynamics: The competitive landscape is niche, with regulatory and patient demand factors influencing the market.
• Future Outlook: Potential new applications and market expansion could drive future growth, despite recent setbacks in clinical trials.

FAQs

1. What is mecamylamine hydrochloride used for?

   • Mecamylamine hydrochloride is used to treat hypertension, nicotine dependence, autonomic dysreflexia, and has been explored for treating Tourette syndrome and major depression.

2. Why was mecamylamine hydrochloride withdrawn from the market in 2009?

   • It was voluntarily withdrawn by Targacept for reasons not related to safety or efficacy.

3. Who currently markets mecamylamine hydrochloride?

   • After several changes in ownership, Turing Pharmaceuticals acquired the rights to mecamylamine hydrochloride from Retrophin.

4. What are the potential new therapeutic applications of mecamylamine hydrochloride?

   • It is being investigated for treating nicotine, cocaine, and other substance dependencies, as well as neuropsychiatric disorders like major depression.

5. What are the financial implications of the drug's market fluctuations?

   • The drug's revenue has seen significant fluctuations due to its withdrawal and re-introduction, along with the costs associated with ongoing research and development.

Sources

1. Wikipedia - Mecamylamine
2. Tocris Bioscience - Mecamylamine hydrochloride
3. PubMed - Mecamylamine: new therapeutic uses and toxicity/risk profile
4. Cognitive Market Research - Global Mecamylamine Hydrochloride Market Report 2024 Edition
5. HHS.gov - Smoking Cessation: A Report of the Surgeon General