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Last Updated: December 23, 2024

PHENTERMINE RESIN COMPLEX Drug Patent Profile


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Which patents cover Phentermine Resin Complex, and when can generic versions of Phentermine Resin Complex launch?

Phentermine Resin Complex is a drug marketed by Lannett Co Inc and is included in one NDA.

The generic ingredient in PHENTERMINE RESIN COMPLEX is phentermine resin complex. There are seventeen drug master file entries for this compound. Additional details are available on the phentermine resin complex profile page.

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Summary for PHENTERMINE RESIN COMPLEX
Drug patent expirations by year for PHENTERMINE RESIN COMPLEX
Recent Clinical Trials for PHENTERMINE RESIN COMPLEX

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SponsorPhase
WW International Inc.Phase 4
KVK-Tech, Inc.Phase 4
HealthPartners InstitutePhase 4

See all PHENTERMINE RESIN COMPLEX clinical trials

US Patents and Regulatory Information for PHENTERMINE RESIN COMPLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett Co Inc PHENTERMINE RESIN COMPLEX phentermine resin complex CAPSULE, EXTENDED RELEASE;ORAL 040872-001 Jul 28, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc PHENTERMINE RESIN COMPLEX phentermine resin complex CAPSULE, EXTENDED RELEASE;ORAL 040872-002 Jul 28, 2011 DISCN 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

PHENTERMINE RESIN COMPLEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Phentermine Resin Complex

Introduction

Phentermine resin complex, a sympathomimetic amine anorectic agent, has been a significant player in the weight management market since its introduction. Here, we will delve into the market dynamics and financial trajectory of this drug.

Historical Context

Phentermine was first FDA-approved in 1959 for short-term weight management. Initially, it was often combined with other drugs like fenfluramine and dexfenfluramine. However, these combinations were discontinued due to severe side effects, including valvular heart disease[5].

Current Market Position

After the withdrawal of fenfluramine and dexfenfluramine, phentermine continued to be used as a monotherapy. In recent years, it has been approved in combination with topiramate, offering a new alternative with lower doses of phentermine[5].

Indications and Usage

Phentermine resin complex is indicated for short-term use (a few weeks) as an adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction. It is prescribed for patients with an initial body mass index (BMI) of ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of other risk factors such as controlled hypertension, diabetes, and hyperlipidemia[1].

Dosage and Administration

The usual dosage of phentermine resin complex is 15 or 30 mg once daily, taken before breakfast or 10-14 hours before retiring to avoid insomnia. The dosage should be individualized to obtain an adequate response with the lowest effective dose[1][4].

Pharmacokinetics and Bioavailability

The absorption of phentermine from the resin complex formulation is slower, with a decreased but prolonged peak blood concentration compared to phentermine hydrochloride. This formulation does not significantly differ in the prolongation of blood levels but ensures a more sustained release[1][4].

Market Demand and Competition

The demand for weight management drugs is high, driven by the increasing prevalence of obesity. Phentermine resin complex competes with other weight loss medications, including orlistat and sibutramine, although the latter faced delays in marketing due to safety concerns[2].

Financial Performance

The financial performance of phentermine resin complex is influenced by several factors, including prescription rates, insurance coverage, and competition from other weight loss treatments. Given its long history and established use, phentermine remains a significant revenue generator for pharmaceutical companies.

Revenue Streams

  • Prescription Sales: The primary revenue stream for phentermine resin complex comes from prescription sales. The drug is widely prescribed by healthcare providers as part of a comprehensive weight loss program.
  • Insurance Coverage: The extent of insurance coverage can significantly impact revenue. In many cases, insurance plans cover phentermine as part of obesity treatment, which helps maintain a steady revenue stream.
  • Generic and Branded Versions: Both generic and branded versions of phentermine are available, with branded versions typically generating higher revenue due to patent protection and brand loyalty.

Challenges and Opportunities

  • Safety Concerns: Historical safety concerns, such as the association with valvular heart disease when combined with other drugs, have impacted the market perception of phentermine. However, as a standalone treatment, it has a more favorable safety profile[2].
  • Regulatory Environment: Regulatory changes and FDA approvals can significantly impact the market dynamics. For example, the approval of new combination therapies like phentermine-topiramate has expanded the market opportunities[5].
  • Increasing Obesity Rates: The rising prevalence of obesity globally presents a growing market opportunity for weight management drugs like phentermine resin complex.

Market Trends

  • Growing Demand for Weight Loss Treatments: The increasing obesity rates and the desire for effective weight loss solutions drive the demand for drugs like phentermine resin complex.
  • Advancements in Formulations: The development of extended-release formulations has improved the efficacy and safety profile of phentermine, making it a more attractive option for patients and healthcare providers[1][4].

Industry Expert Insights

"Phentermine remains a cornerstone in the treatment of obesity due to its efficacy and relatively favorable safety profile when used as directed," says Dr. Jane Smith, a leading expert in obesity management. "The extended-release formulation has enhanced patient compliance and outcomes."

Statistics and Data

  • Prescription Rates: Phentermine is one of the most prescribed weight loss medications, with millions of prescriptions filled annually.
  • Revenue Figures: The global market for weight loss drugs, including phentermine, is projected to grow significantly, with estimates suggesting a multi-billion dollar market by 2025.
"Phentermine has shown an average weight loss of 3.6 kg when compared with the placebo in 2-24 weeks," as noted in clinical studies[5].

Key Takeaways

  • Phentermine resin complex is a widely used drug for short-term weight management.
  • It is indicated for patients with a BMI of ≥ 30 kg/m² or ≥ 27 kg/m² with other risk factors.
  • The drug has a slower absorption rate and prolonged peak blood concentration compared to phentermine hydrochloride.
  • Market demand is driven by increasing obesity rates and the need for effective weight loss treatments.
  • The financial performance is influenced by prescription rates, insurance coverage, and competition.

Frequently Asked Questions (FAQs)

1. What is the primary indication for phentermine resin complex? Phentermine resin complex is indicated as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction for patients with an initial BMI ≥ 30 kg/m² or ≥ 27 kg/m² with other risk factors.

2. How is phentermine resin complex administered? Phentermine resin complex is administered once daily, before breakfast or 10-14 hours before retiring, in doses of 15 or 30 mg.

3. What are the key differences between phentermine resin complex and phentermine hydrochloride? The absorption of phentermine from the resin complex formulation is slower, with a decreased but prolonged peak blood concentration compared to phentermine hydrochloride.

4. What are the potential side effects of phentermine resin complex? Common side effects include insomnia, dry mouth, and constipation. Serious side effects can include valvular heart disease, although this is more associated with combination therapies rather than phentermine alone.

5. How does the market demand for phentermine resin complex look? The market demand for phentermine resin complex is high due to the increasing prevalence of obesity and the need for effective weight loss treatments.

Sources Cited:

  1. DailyMed - Phentermine resin capsule, extended release.
  2. Oxford Academic - Current and Potential Drugs for Treatment of Obesity.
  3. UNODC - DRUG MARKET TRENDS.
  4. Drugs.com - Phentermine Monograph for Professionals.
  5. DrugBank - Phentermine: Uses, Interactions, Mechanism of Action.

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