TRANYLCYPROMINE SULFATE - Generic Drug Details

What are the generic drug sources for tranylcypromine sulfate and what is the scope of patent protection?

Tranylcypromine sulfate is the generic ingredient in two branded drugs marketed by Concordia, Crossmedika Sa, Novitium Pharma, and Strides Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for tranylcypromine sulfate. Five suppliers are listed for this compound.

Summary for TRANYLCYPROMINE SULFATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	1
What excipients (inactive ingredients) are in TRANYLCYPROMINE SULFATE?	TRANYLCYPROMINE SULFATE excipients list
DailyMed Link:	TRANYLCYPROMINE SULFATE at DailyMed

Pharmacology for TRANYLCYPROMINE SULFATE

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for TRANYLCYPROMINE SULFATE

Anti-Anxiety Agents

Antidepressive Agents

Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRANYLCYPROMINE SULFATE

N06AF	Monoamine oxidase inhibitors, non-selective
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for TRANYLCYPROMINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	040640-001	Jun 29, 2006	AB	RX	No	No
Concordia	PARNATE	tranylcypromine sulfate	TABLET;ORAL	012342-003	Aug 16, 1985	AB	RX	Yes	Yes
Novitium Pharma	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856-001	Apr 17, 2018	AB	RX	No	No
Crossmedika Sa	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	213503-001	Jun 27, 2022	AB	RX	No	No

TRANYLCYPROMINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tranylcypromine Sulfate

Introduction

Tranylcypromine sulfate, a monoamine oxidase inhibitor (MAOI), has a complex and evolving history in the treatment of depressive disorders. Introduced in 1961, it has faced significant challenges and changes in its market dynamics and financial trajectory.

Historical Context

Tranylcypromine was initially introduced for the treatment of certain depressive disorders but was withdrawn from the market in 1964 due to reports of severe adverse reactions, including hypertensive crises and intracranial bleeding[4].

Reintroduction and Current Indications

After its withdrawal, tranylcypromine was reintroduced with more limited indications and stringent precautions. It is now primarily used for the treatment of major depressive episodes in patients with treatment-resistant depressive disorder, where standard antidepressants and augmentation therapies (such as lithium) have been ineffective[1][3][5].

Market Demand

The demand for tranylcypromine sulfate is niche but significant, given the specific patient population it targets. Patients who have failed multiple treatments for depression represent a smaller but critical segment of the antidepressant market. The efficacy of tranylcypromine in this group, with response rates ranging from 20-81% in various studies, supports its continued use[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of tranylcypromine. The drug has undergone rigorous evaluation, including bioequivalence studies to ensure its safety and efficacy. For instance, the approval of Tranylcypromine Double-e Pharma 10 mg film-coated tablets involved a comprehensive review by the Medicines Evaluation Board (MEB) of the Netherlands, which granted marketing authorization based on bioequivalence with the reference product[1].

Safety and Efficacy Concerns

Despite its efficacy, tranylcypromine is associated with significant side effects, including frequent hypotension and the risk of severe hypertension with potentially fatal outcomes. These safety concerns necessitate careful patient selection and monitoring, which can impact its market adoption[3].

Financial Trajectory

Generic Formulations

The introduction of generic formulations, such as Tranylcypromine Double-e Pharma, has influenced the financial trajectory of the drug. Generic versions can reduce costs and increase accessibility, potentially expanding the market share. However, the profitability may be lower compared to branded products due to competitive pricing[1].

Pricing and Reimbursement

The pricing of tranylcypromine sulfate is influenced by regulatory and reimbursement policies. In many countries, the drug is covered under health insurance plans, but the extent of coverage can vary. The cost-effectiveness of tranylcypromine, especially in comparison to other antidepressants, is a critical factor in its financial performance.

Market Competition

The antidepressant market is highly competitive, with numerous drugs available for various types of depression. Tranylcypromine's niche position as a treatment for treatment-resistant depression means it competes primarily with other MAOIs and specialized antidepressants rather than broad-spectrum antidepressants.

Clinical Studies and Data

Clinical studies have been pivotal in shaping the market dynamics of tranylcypromine. Recent meta-analyses and studies have supported its efficacy in treatment-resistant depression, although there is still substantial uncertainty regarding the proportion of responders, especially with the inclusion of lithium augmentation[3].

Long-Term Safety Data

The lack of long-term safety data is a significant concern. Most studies have reported data up to 8 weeks, leaving a gap in understanding the long-term safety profile of tranylcypromine. This uncertainty can impact prescribing decisions and, consequently, the drug's financial performance[3].

Patient Population and Compliance

The patient population for tranylcypromine is characterized by their resistance to other treatments, making compliance and adherence critical. The complexity of the treatment regimen, including dietary restrictions due to MAOI interactions, can affect patient compliance and thus influence the drug's market success.

Future Outlook

Given the specific indications and the need for careful patient management, the market for tranylcypromine sulfate is likely to remain niche. However, advancements in clinical trials and better understanding of its long-term safety profile could enhance its market position. Additionally, the development of more patient-friendly formulations or combination therapies could improve its financial trajectory.

Key Takeaways

• Niche Market: Tranylcypromine sulfate targets a specific segment of the antidepressant market, focusing on treatment-resistant depression.
• Regulatory Approval: Rigorous regulatory evaluations, including bioequivalence studies, are crucial for its market presence.
• Safety Concerns: Significant side effects and the need for careful patient monitoring impact its market adoption.
• Generic Formulations: Generic versions can increase accessibility but may reduce profitability.
• Clinical Studies: Ongoing studies and meta-analyses support its efficacy, but long-term safety data is limited.

FAQs

What is the primary indication for tranylcypromine sulfate?

Tranylcypromine sulfate is primarily indicated for the treatment of major depressive episodes in patients with treatment-resistant depressive disorder who have not responded to at least two standard antidepressants and augmentation therapies like lithium[1][3][5].

What are the significant side effects of tranylcypromine sulfate?

The drug is associated with frequent hypotension and the risk of severe hypertension with potentially fatal outcomes, including hypertensive crises and intracranial bleeding[3][4].

How has the reintroduction of tranylcypromine sulfate affected its market dynamics?

The reintroduction with more limited indications and stringent precautions has targeted a niche market, focusing on patients who have failed other treatments. This has maintained its relevance but also limited its broader market potential[4].

What role do generic formulations play in the market dynamics of tranylcypromine sulfate?

Generic formulations, such as Tranylcypromine Double-e Pharma, increase accessibility and reduce costs, potentially expanding the market share, but may reduce profitability compared to branded products[1].

What are the challenges in long-term use of tranylcypromine sulfate?

The lack of long-term safety data is a significant concern, with most studies reporting data up to 8 weeks. This uncertainty affects prescribing decisions and the drug's overall market performance[3].

Sources

1. Scientific discussion Tranylcypromine Double-e Pharma 10 mg, film-coated tablets. Geneesmiddeleninformatiebank.nl.
2. Investor Relations | Molina Healthcare Inc.. Molina Healthcare Inc.
3. Public Assessment Report Scientific discussion Abbonate Film-coated tablet. Docetp.mpa.se.
4. Reevaluation of Tranylcypromine Sulfate: (Parnate Sulfate). JAMA.
5. PARNATE - accessdata.fda.gov. FDA.