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Last Updated: December 22, 2024

PARNATE Drug Patent Profile


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Which patents cover Parnate, and what generic alternatives are available?

Parnate is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in PARNATE is tranylcypromine sulfate. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tranylcypromine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Parnate

A generic version of PARNATE was approved as tranylcypromine sulfate by STRIDES PHARMA on June 29th, 2006.

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Summary for PARNATE
Drug patent expirations by year for PARNATE
Drug Prices for PARNATE

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Recent Clinical Trials for PARNATE

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SponsorPhase
Sheppard Pratt Health SystemN/A
Central Michigan UniversityN/A
National Institute of Mental Health (NIMH)Phase 4

See all PARNATE clinical trials

Pharmacology for PARNATE

US Patents and Regulatory Information for PARNATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia PARNATE tranylcypromine sulfate TABLET;ORAL 012342-003 Aug 16, 1985 AB RX Yes Yes ⤷  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

PARNATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PARNATE

Introduction

PARNATE, also known as tranylcypromine sulfate, is a monoamine oxidase inhibitor (MAOI) used in the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Here, we will delve into the market dynamics and financial trajectory associated with this drug.

Market Context

The pharmaceutical market, particularly the segment focused on mental health treatments, is complex and influenced by various factors.

Global Pharmaceutical Market

The global pharmaceutical market is projected to grow significantly, with revenues expected to exceed $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases, including mental health disorders[3].

Mental Health Market

The market for antidepressants, including MAOIs like PARNATE, is part of this larger pharmaceutical landscape. The demand for effective treatments for MDD and other psychiatric disorders continues to rise, driven by the growing awareness and diagnosis of mental health issues.

Clinical Use and Indications

PARNATE is indicated for the treatment of MDD in adult patients who have not responded adequately to other antidepressants. It is not recommended for the initial treatment of MDD due to potential serious adverse reactions and the need for dietary restrictions[4].

Efficacy and Safety

The effectiveness of PARNATE in patients with major depressive episodes, especially those with endogenous features (melancholia), has not been established. However, it has been shown to increase the concentration of epinephrine, norepinephrine, and serotonin in the nervous system, which can help alleviate depressive symptoms[1].

Regulatory and Safety Considerations

The use of PARNATE is subject to several regulatory and safety considerations.

Contraindications

PARNATE should not be administered in combination with other MAO inhibitors, dibenzazepine derivatives, or hypotensive agents due to a marked potentiating effect. It is also contraindicated in patients with a history of liver disease or abnormal liver function tests[1].

Drug Interactions

Switching from or to other antidepressants requires careful timing to avoid additive effects. For example, after stopping treatment with contraindicated antidepressants, a time period of 4 to 5 half-lives of the other antidepressant or any active metabolite should elapse before starting PARNATE[4].

Financial Trajectory

The financial performance of pharmaceutical companies developing and marketing drugs like PARNATE is influenced by several factors, including development costs, market demand, and regulatory environments.

Development Costs

The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. This high cost, combined with a low probability of success (around 10% for drugs entering clinical trials), makes pharmaceutical R&D highly risky[3].

Revenue Potential

Successful drugs, especially those addressing high unmet medical needs, can generate significant revenue. For instance, blockbuster drugs like AbbVie's Humira, which lost patent exclusivity in 2023, can generate over $20 billion in annual revenue at their peak[3].

Market Competition

The market for antidepressants is competitive, with various classes of drugs available, including SSRIs, SNRIs, and other MAOIs. PARNATE's niche as a treatment for patients who have not responded to other antidepressants positions it in a specific segment of this market.

Financial Performance of Pharmaceutical Companies

While PARNATE itself is not a blockbuster drug, the financial performance of the companies that develop and market such drugs can provide insights into the broader financial dynamics.

Revenue and Expenses

Companies like Perella Weinberg Partners, which may advise or invest in pharmaceutical firms, report revenues and expenses that reflect the broader industry trends. For example, Perella Weinberg Partners reported revenues of $648.7 million for the twelve months ended December 31, 2023, with a focus on expanding client coverage and talent investment[2].

Challenges and Opportunities

The pharmaceutical industry, including the segment focused on drugs like PARNATE, faces several challenges and opportunities.

Regulatory Hurdles

Stricter regulatory hurdles and shorter exclusivity periods due to patent challenges and the introduction of generic or biosimilar competitors can significantly impact a company's ability to recoup its R&D investment[3].

Unmet Medical Needs

The growing global burden of chronic diseases, including mental health disorders, presents opportunities for pharmaceutical companies to develop new treatments. Precision medicine and the use of genomic sequencing are emerging trends that could optimize treatment efficacy and minimize adverse events[3].

Key Takeaways

  • Market Growth: The global pharmaceutical market is projected to grow significantly, driven by the increasing burden of chronic diseases.
  • Clinical Use: PARNATE is used for treating MDD in patients who have not responded to other antidepressants, with specific clinical and safety considerations.
  • Regulatory and Safety: The drug has several contraindications and requires careful management of drug interactions.
  • Financial Dynamics: The development and marketing of drugs like PARNATE involve high costs and risks but also potential for significant revenue.
  • Industry Trends: The pharmaceutical industry faces challenges such as regulatory hurdles and declining ROI but also opportunities in addressing unmet medical needs.

FAQs

  1. What is PARNATE used for? PARNATE (tranylcypromine sulfate) is used for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants[4].

  2. What are the contraindications for PARNATE? PARNATE should not be administered in combination with other MAO inhibitors, dibenzazepine derivatives, or hypotensive agents. It is also contraindicated in patients with a history of liver disease or abnormal liver function tests[1].

  3. How long does it take to develop a new drug like PARNATE? The development timeline for a new drug typically spans 10 to 15 years, with an average cost of approximately $2.6 billion[3].

  4. What are the potential financial returns for a successful drug? Successful drugs, especially those addressing high unmet medical needs, can generate significant revenue, with some blockbuster drugs reaching annual sales exceeding $1 billion[3].

  5. What are the challenges faced by pharmaceutical companies in developing new drugs? Pharmaceutical companies face challenges such as increasing regulatory hurdles, shorter exclusivity periods, and declining ROI, which can impact their ability to recoup R&D investments[3].

Sources

  1. PARNATE - accessdata.fda.gov
  2. Perella Weinberg Reports Full Year and Fourth Quarter 2023 Results
  3. Investment Trends in Pharmaceutical Research - DrugBank Blog
  4. Parnate (Tranylcypromine): Side Effects, Uses, Dosage, Interactions ... - RxList

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