IMIPRAMINE PAMOATE - Generic Drug Details

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

Imipramine pamoate is the generic ingredient in two branded drugs marketed by Hikma, Lupin Ltd, Rising, and Specgx Llc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for imipramine pamoate. Two suppliers are listed for this compound.

Summary for IMIPRAMINE PAMOATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	2
Patent Applications:	3
Drug Prices:	Drug price trends for IMIPRAMINE PAMOATE
What excipients (inactive ingredients) are in IMIPRAMINE PAMOATE?	IMIPRAMINE PAMOATE excipients list
DailyMed Link:	IMIPRAMINE PAMOATE at DailyMed

See drug prices for IMIPRAMINE PAMOATE

Recent Clinical Trials for IMIPRAMINE PAMOATE

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

Sponsor	Phase
Shalvata Mental Health Center	N/A
Roxane Laboratories	N/A

See all IMIPRAMINE PAMOATE clinical trials

Pharmacology for IMIPRAMINE PAMOATE

Drug Class

Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for IMIPRAMINE PAMOATE

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for IMIPRAMINE PAMOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	IMIPRAMINE PAMOATE	imipramine pamoate	CAPSULE;ORAL	090444-002	Apr 16, 2010	AB	RX	No	No
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma	IMIPRAMINE PAMOATE	imipramine pamoate	CAPSULE;ORAL	091099-002	Apr 16, 2010	AB	RX	No	No
Hikma	IMIPRAMINE PAMOATE	imipramine pamoate	CAPSULE;ORAL	091099-003	Apr 16, 2010	AB	RX	No	No
Rising	IMIPRAMINE PAMOATE	imipramine pamoate	CAPSULE;ORAL	202338-004	Jun 28, 2013		DISCN	No	No

IMIPRAMINE PAMOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Imipramine Pamoate

Introduction

Imipramine pamoate, marketed under the brand name Tofranil-PM, is a tricyclic antidepressant used primarily for the treatment of depression and certain anxiety disorders. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Presence and Availability

Imipramine pamoate is widely available for medical use globally, including in the United States, the United Kingdom, Europe, India, Brazil, South Africa, Australia, and New Zealand[1][3][4].

Prescription Trends

Historically, imipramine and its related compounds have been among the most commonly prescribed antidepressants. Between 1998 and 2017, imipramine was one of the most frequently prescribed first antidepressants for children aged 5-11 years in England, often alongside amitriptyline[1].

Generic and Branded Formulations

Imipramine pamoate is available in both generic and branded forms. The branded version, Tofranil-PM, is marketed by companies like Mallinckrodt, which acquired the rights from Novartis International AG. Generic formulations are also widely available, contributing to the drug's broad market presence[1][3].

Pharmaceutical Company Strategies

Companies like Mallinckrodt have expanded their pharmaceutical formulation capabilities, which includes a strong portfolio of generic products and controlled substance APIs. This expansion has enhanced their market position, particularly in the controlled substance generics market. The company's strategy involves investing in research and development, promoting branded products directly to physicians, and engaging in co-promotions and line extensions[3].

Financial Performance

The financial performance of imipramine pamoate is tied to the overall performance of its parent companies. For instance, Mallinckrodt's Specialty Pharmaceuticals segment, which includes Tofranil-PM, has been a growth area. The company's focus on pain management and the development of new products has contributed to its financial stability and growth prospects[3].

Cost and Coverage

The cost and coverage of imipramine pamoate vary significantly depending on the healthcare system and insurance plans. In the United States, for example, the Affordable Care Act (ACA) has influenced the coverage and cost-sharing requirements for antidepressants, including imipramine pamoate. States have implemented different limits on copays and out-of-pocket costs, affecting the financial burden on patients[2].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of imipramine pamoate. FDA approvals and regulatory reviews are essential for maintaining and expanding the drug's market presence. For instance, the FDA's acceptance and review of new formulations and dosages can impact the drug's sales and market share[3][4].

Side Effects and Safety Concerns

The safety profile of imipramine pamoate, including potential side effects such as suicidal thoughts in young adults, hypomanic or manic episodes, and interactions with other treatments, can influence its prescription rates and market dynamics. These concerns necessitate careful monitoring and dosage adjustments, which can affect the drug's overall financial performance[4][5].

Market Competition

The antidepressant market is highly competitive, with numerous generic and branded options available. Imipramine pamoate competes with other tricyclic antidepressants, as well as newer classes of antidepressants like SSRIs and SNRIs. The availability of generic alternatives can reduce the market share of branded versions, impacting the financial trajectory of Tofranil-PM[1][2].

Patient and Prescriber Preferences

Patient and prescriber preferences also play a significant role in the market dynamics of imipramine pamoate. The drug's efficacy in treating severe depression and certain anxiety disorders, along with its side effect profile, influences prescriber decisions. Patient compliance and satisfaction can also affect the drug's market performance[1][5].

Third-Party Tools and Transparency

The use of third-party tools to help consumers navigate health insurance plans and prescription costs can impact the financial trajectory of imipramine pamoate. These tools, while not yet fully integrated into marketplaces, can help direct consumers to the most advantageous health insurance plans, potentially affecting the drug's sales[2].

Global Market Expansion

The global expansion of pharmaceutical companies marketing imipramine pamoate is a key factor in its financial trajectory. Entering new markets, especially in regions with growing healthcare needs, can significantly boost sales and revenue[3].

Key Takeaways

• Market Presence: Imipramine pamoate is widely available globally.
• Prescription Trends: Historically common in pediatric and adult prescriptions.
• Generic and Branded Formulations: Available in both forms, with branded versions marketed by companies like Mallinckrodt.
• Financial Performance: Tied to the performance of parent companies, with a focus on pain management and generic formulations.
• Cost and Coverage: Varies by healthcare system and insurance plans.
• Regulatory Environment: FDA approvals and reviews are crucial.
• Safety Concerns: Side effects and safety concerns influence prescription rates.
• Market Competition: Competes with other antidepressants.
• Patient and Prescriber Preferences: Efficacy and side effect profile are key factors.
• Global Expansion: Entering new markets can boost sales.

FAQs

Q: What is imipramine pamoate used for? A: Imipramine pamoate is primarily used for the treatment of depression and certain anxiety disorders.

Q: Who manufactures Tofranil-PM? A: Tofranil-PM is marketed by companies like Mallinckrodt, which acquired the rights from Novartis International AG.

Q: Are there generic versions of imipramine pamoate available? A: Yes, generic versions of imipramine pamoate are widely available.

Q: What are the potential side effects of imipramine pamoate? A: Potential side effects include suicidal thoughts in young adults, hypomanic or manic episodes, and interactions with other treatments.

Q: How does the regulatory environment impact imipramine pamoate? A: FDA approvals and regulatory reviews are essential for maintaining and expanding the drug's market presence.

Cited Sources

1. Wikipedia: Imipramine - Wikipedia
2. Urban Institute: Marketplace Antidepressant Coverage and Transparency
3. Mallinckrodt Investor Relations: Mallinckrodt public limited company - Investor Relations
4. FDA: Tofranil-PM™ (imipramine pamoate) capsules
5. Mayo Clinic: Imipramine (oral route) - Mayo Clinic