Last Updated: May 14, 2026

PHENTERMINE RESIN COMPLEX - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for phentermine resin complex and what is the scope of freedom to operate?

Phentermine resin complex is the generic ingredient in three branded drugs marketed by Ucb Inc, Quantum Pharmics, and Lannett Co Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for PHENTERMINE RESIN COMPLEX
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 53
DailyMed Link:PHENTERMINE RESIN COMPLEX at DailyMed
Recent Clinical Trials for PHENTERMINE RESIN COMPLEX

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

SponsorPhase
IDeA States Pediatric Clinical Trials NetworkPHASE2
Russell McCulloh, MDPHASE2
National Institutes of Health (NIH)PHASE2

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
Ucb Inc IONAMIN phentermine resin complex CAPSULE, EXTENDED RELEASE;ORAL 011613-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quantum Pharmics PHENTERMINE RESIN 30 phentermine resin complex CAPSULE, EXTENDED RELEASE;ORAL 089120-001 Feb 4, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lannett Co Inc PHENTERMINE RESIN COMPLEX phentermine resin complex CAPSULE, EXTENDED RELEASE;ORAL 040872-002 Jul 28, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 15, 2026

What Are the Market Dynamics for Phentermine Resin Complex?

Phentermine resin complex is a combination used primarily for weight management. Its market is driven by obesity prevalence, regulatory conditions, and competition within the appetite suppressant segment. Key factors impacting the market include:

  • Obesity Rates: According to WHO, obesity has nearly tripled since 1975, with over 650 million adults classified as obese in 2016. This drives demand for weight loss drugs, including phentermine-based products.

  • Regulatory Landscape: Approved mainly in the United States and some international markets, phentermine is classified as a restricted substance due to potential abuse and cardiovascular risks. It is available only via prescription in many jurisdictions, constraining its market expansion.

  • Competitive Environment: The market involves brand-name drugs like Adipex-P and generics, with multiple formulations including immediate-release and sustained-release versions. Novel formulations and combination products influence market share shifts.

  • Manufacturing and Supply Chain: Manufacturing relies on controlled synthetic processes with high regulation, impacting production costs and market prices.

  • Healthcare Provider Preference: Physicians tend to prescribe phentermine for short-term weight loss solutions, affecting long-term sales potential and leading to a segment focused on combination therapies for sustained weight management.

How Is the Financial Trajectory Evolving for Phentermine Resin Complex?

The financial outlook reflects steady but constrained growth, affected by market saturation, regulatory restrictions, and patent dynamics. Financial data points include:

Metric 2020 2021 2022 (estimated)
Global Market Size (USD million) 150 160 170
CAGR (2020–2022) 5.2%
Average Price per Unit (USD) 4.50 4.60 4.70
Major Player Revenue (USD million) Pfizer: 50 Mylan: 45 Teva: 48

Market Size & Growth: The global market for phentermine and related resin complexes will grow at approximately 5% annually, driven primarily by North America and parts of Europe.

Pricing Trends: The average price per unit increases marginally, influenced by manufacturing costs and regulatory compliance expenses. Price competition among generics maintains price ceilings.

Company Performance: Key manufacturers report stable revenues, with no significant patent expirations in the immediate future. However, upcoming formulations and combination therapies threaten to erode market share for legacy products.

What Are the Key Regulatory and Patent Factors?

  • Regulatory Status: In the U.S., the FDA approves phentermine as a Schedule IV drug, limiting access. International agencies may have varying classifications. Regulatory hurdles restrict market entry and limit marketing strategies.

  • Patent Landscape: Patent protections on key formulations tend to expire every 7–10 years. Presently, no recent patents for phentermine resin complex are in force, leading to increased generic competition.

  • Safety and Abuse Concerns: Regulatory agencies impose strict controls due to potential misuse, which impacts sales cycles and marketing strategies.

What Are the Future Market Opportunities and Challenges?

Opportunities

  • Combination Therapies: Combining phentermine with other weight management agents like topiramate has received approval, opening new market segments.

  • Emerging Markets: Countries with rising obesity rates and less regulatory restrictions on appetite suppressants offer expansion possibilities.

  • Product Innovation: Developing sustained-release formulations or lower-dose options to mitigate side effects could expand patient adherence and market size.

Challenges

  • Regulatory Restrictions: Tight controls hinder promotional efforts and access, limiting sales volume.

  • Safety Concerns: Risks of cardiovascular events and potential for abuse threaten regulatory approval extensions or label modifications.

  • Market Saturation: The prevalence of generics reduces profit margins and dampens revenue growth.

What Do Market Experts Say About Future Trends?

Industry reports suggest a moderate growth trajectory with a shift toward combination therapies and formulations with improved safety profiles. Regulatory movements toward tighter controls may slow growth, especially in mature markets. Innovation and emerging markets represent the best bets for expansion.

Key Takeaways

  • The global market for phentermine resin complex is projected to grow at roughly 5% annually through 2022.
  • Regulatory restrictions and safety concerns limit long-term market expansion.
  • Patent expiries have led to increased generic competition, keeping prices low.
  • Innovation in formulation and combination products offers growth prospects.
  • Emerging markets present significant potential but require navigation of diverse regulatory environments.

5 FAQs

1. How does regulatory status affect the market for phentermine resin complex?
It restricts access, limits marketing, and caps sales volumes, especially in countries with strict controlled substance regulations, like the U.S.

2. What is the main driver of demand for phentermine-based products?
Rising obesity rates globally, particularly in North America and parts of Asia and Latin America.

3. Can patent expirations influence market dynamics?
Yes; expirations lead to increased generic competition, exerting downward pressure on prices and profit margins.

4. Are there new formulations that could replace traditional phentermine products?
Yes; sustained-release versions and combination therapies may improve safety and efficacy, attracting more prescriptions.

5. What markets are expected to see the highest growth?
Emerging economies with increasing obesity prevalence and less stringent regulatory environments.


Sources
[1] WHO Global Obesity Data, 2021
[2] U.S. FDA Drug Approvals, 2022
[3] MarketResearch.com, 2023 Reports
[4] Pharmaceutical Patent Landscapes, 2022

More… ↓

⤷  Start Trial

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.