PHENELZINE SULFATE - Generic Drug Details

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

Phenelzine sulfate is the generic ingredient in two branded drugs marketed by Parke Davis and Novel Labs Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for phenelzine sulfate. Three suppliers are listed for this compound.

Summary for PHENELZINE SULFATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	4
Patent Applications:	3,193
Drug Prices:	Drug price trends for PHENELZINE SULFATE
What excipients (inactive ingredients) are in PHENELZINE SULFATE?	PHENELZINE SULFATE excipients list
DailyMed Link:	PHENELZINE SULFATE at DailyMed

See drug prices for PHENELZINE SULFATE

Recent Clinical Trials for PHENELZINE SULFATE

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1
The Canberra Hospital	Phase 1
Southern Medical Day Care Centre	Phase 1

See all PHENELZINE SULFATE clinical trials

Pharmacology for PHENELZINE SULFATE

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for PHENELZINE SULFATE

Antidepressive Agents

Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PHENELZINE SULFATE

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

US Patents and Regulatory Information for PHENELZINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	NARDIL	phenelzine sulfate	TABLET;ORAL	011909-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Novel Labs Inc	PHENELZINE SULFATE	phenelzine sulfate	TABLET;ORAL	200181-001	Dec 8, 2010	AB	RX	No	No

PHENELZINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phenelzine Sulfate

Introduction

Phenelzine sulfate, marketed under the brand name Nardil, is a potent non-selective monoamine oxidase inhibitor (MAOI) used primarily in the treatment of various depressive disorders and other psychiatric conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients alike.

Market Demand and Patient Profile

Phenelzine sulfate is particularly effective in treating patients with atypical, non-endogenous, or neurotic depression, as well as those who are treatment-resistant to first and second-line antidepressants[2][3][4].

• Patient Base: The drug is indicated for adults, with a specific focus on those who have not responded well to other treatments. This niche market ensures a steady demand, albeit limited to a specific segment of the psychiatric patient population.
• Geographical Distribution: The demand for phenelzine sulfate is global, but its availability is affected by regional supply chain issues. For instance, Canada and Australia have faced shortages due to global issues with the active pharmaceutical ingredient[1][5].

Supply Chain and Availability

The supply of phenelzine sulfate has been marred by significant challenges:

• Global Shortages: There has been a global shortage of the active ingredient, leading to supply disruptions in several countries, including Canada and Australia[1][5].
• Discontinuation in Australia: The supply of phenelzine sulfate has been discontinued in Australia due to manufacturing issues, forcing patients to seek alternative treatments or access the drug through special access schemes[5].
• Alternative Access Pathways: In regions where the drug is in short supply, patients may access it through special access schemes, such as the Special Access Scheme (SAS) in Australia. However, these pathways are not guaranteed and can be costly[5].

Financial Implications

The financial trajectory of phenelzine sulfate is influenced by several factors:

• Revenue Impact: Despite its niche market, phenelzine sulfate generates significant revenue for its manufacturers due to its high demand among treatment-resistant patients. However, supply shortages can lead to revenue losses and increased costs associated with managing these shortages.
• Cost to Patients: Patients facing supply disruptions may incur additional costs due to the need for alternative treatments or accessing the drug through special pathways. This can include higher out-of-pocket expenses and potential travel costs to consult specialists[5].

Pricing and Reimbursement

The pricing of phenelzine sulfate varies by region and is influenced by factors such as manufacturing costs, regulatory approvals, and reimbursement policies:

• Pricing Strategies: Manufacturers often set prices based on the drug's efficacy, the lack of alternative treatments, and the cost of production. However, in regions where the drug is in short supply, prices may fluctuate due to market demand and supply constraints.
• Reimbursement: In many countries, phenelzine sulfate is covered by healthcare insurance plans, but the extent of coverage can vary. For instance, in Australia, medicines obtained through the Special Access Scheme are not subsidized by the government, making them potentially more expensive for patients[5].

Competitive Landscape

The competitive landscape for MAOIs like phenelzine sulfate is relatively niche:

• Market Share: Phenelzine sulfate competes with other MAOIs such as tranylcypromine and isocarboxazid. However, its unique efficacy profile in treating atypical depression ensures a dedicated market share[2][3].
• New Entrants: The entry of new MAOIs or alternative treatments could potentially disrupt the market. However, the complexity of MAOI therapy and the need for careful patient management make it challenging for new entrants to immediately gain significant market share.

Regulatory Environment

Regulatory factors play a crucial role in the market dynamics of phenelzine sulfate:

• FDA and Health Canada Regulations: The drug is subject to strict regulations, including FDA Box Warnings regarding the risk of suicidal thinking and behavior in children, adolescents, and young adults. These regulations can impact prescribing practices and patient access[2][4].
• Special Access Schemes: Regulatory bodies like the Therapeutic Goods Administration (TGA) in Australia provide special access schemes to ensure patients can access essential medications during shortages. These schemes are subject to regulatory oversight and can influence the financial trajectory of the drug[5].

Future Outlook

The future outlook for phenelzine sulfate is marked by both opportunities and challenges:

• Research and Development: Ongoing research into the neuroprotective and regenerative properties of phenelzine sulfate could expand its indications and increase its market potential. For example, studies on its use in treating conditions like stroke, traumatic brain injury, and multiple sclerosis are promising[2][3].
• Supply Chain Stability: Efforts to stabilize the supply chain and address global shortages are critical for maintaining market stability and ensuring patient access.
• Alternative Treatments: The development of new antidepressants and alternative treatments could pose a threat to the market share of phenelzine sulfate. However, its unique efficacy in treating specific types of depression ensures it will remain a valuable treatment option.

Key Takeaways

• Phenelzine sulfate has a dedicated market due to its efficacy in treating atypical and treatment-resistant depression.
• Global shortages and supply chain disruptions significantly impact its availability and financial trajectory.
• Regulatory environments and special access schemes play a crucial role in patient access and cost management.
• Ongoing research into new indications could expand its market potential.
• The competitive landscape is niche, with few alternative MAOIs available.

FAQs

1. What is the primary use of phenelzine sulfate?

   • Phenelzine sulfate is primarily used in the treatment of major depressive disorder, particularly in patients with atypical, non-endogenous, or neurotic depression[2][3][4].

2. Why is there a shortage of phenelzine sulfate?

   • The shortage is due to global issues with the manufacture of the active pharmaceutical ingredient[1][5].

3. How does the supply shortage affect patients?

   • Patients may need to seek alternative treatments or access the drug through special access schemes, which can be costly and may not be guaranteed[5].

4. What are the potential new indications for phenelzine sulfate?

   • Research is ongoing into its potential use in treating conditions such as stroke, traumatic brain injury, spinal cord injury, and multiple sclerosis[2][3].

5. Is phenelzine sulfate covered by healthcare insurance?

   • In many countries, phenelzine sulfate is covered by healthcare insurance plans, but the extent of coverage can vary, especially in regions with supply shortages[5].

Sources

1. AB Pharmacy. "Shortage of drug used to treat depression."
2. NCBI Bookshelf. "Phenelzine - StatPearls."
3. Wikipedia. "Phenelzine."
4. Pfizer. "NARDIL - (Phenelzine Sulfate Tablets, USP)."
5. Therapeutic Goods Administration. "Medicine shortage alert: Discontinuation of Nardil (phenelzine sulfate)."