You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

IMIPRAMINE PAMOATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Imipramine Pamoate patents expire, and what generic alternatives are available?

Imipramine Pamoate is a drug marketed by Hikma, Lupin Ltd, and Rising. and is included in three NDAs.

The generic ingredient in IMIPRAMINE PAMOATE is imipramine pamoate. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Imipramine Pamoate

A generic version of IMIPRAMINE PAMOATE was approved as imipramine pamoate by HIKMA on April 16th, 2010.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for IMIPRAMINE PAMOATE?
  • What are the global sales for IMIPRAMINE PAMOATE?
  • What is Average Wholesale Price for IMIPRAMINE PAMOATE?
Summary for IMIPRAMINE PAMOATE
Drug patent expirations by year for IMIPRAMINE PAMOATE
Drug Prices for IMIPRAMINE PAMOATE

See drug prices for IMIPRAMINE PAMOATE

Recent Clinical Trials for IMIPRAMINE PAMOATE

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

SponsorPhase
Shalvata Mental Health CenterN/A
Roxane LaboratoriesN/A

See all IMIPRAMINE PAMOATE clinical trials

Pharmacology for IMIPRAMINE PAMOATE
Anatomical Therapeutic Chemical (ATC) Classes for IMIPRAMINE PAMOATE

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
Hikma IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 091099-001 Apr 16, 2010 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 090444-003 Apr 16, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 091099-004 Apr 16, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.