Gemfibrozil - Generic Drug Details

What are the generic sources for gemfibrozil and what is the scope of freedom to operate?

Gemfibrozil is the generic ingredient in two branded drugs marketed by Natco, Purepac Pharm, Pfizer Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Chartwell Rx, Epic Pharma Llc, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Norvium Bioscience, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for gemfibrozil

US Patents:	0
Tradenames:	2
Applicants:	19
NDAs:	21
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	43
Patent Applications:	7,067
Drug Prices:	Drug price trends for gemfibrozil
Drug Sales Revenues:	Drug sales revenues for gemfibrozil
What excipients (inactive ingredients) are in gemfibrozil?	gemfibrozil excipients list
DailyMed Link:	gemfibrozil at DailyMed

See drug prices for gemfibrozil

See drug sales revenues for gemfibrozil

Recent Clinical Trials for gemfibrozil

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

Sponsor	Phase
St. Louis University	Early Phase 1
Polaryx Therapeutics, Inc.	Phase 3
Bristol-Myers Squibb	Phase 1

See all gemfibrozil clinical trials

Generic filers with tentative approvals for GEMFIBROZIL

Applicant	Application No.	Strength	Dosage Form
		300MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for gemfibrozil

Drug Class	Peroxisome Proliferator Receptor alpha Agonist
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists

Medical Subject Heading (MeSH) Categories for gemfibrozil

Cytochrome P-450 CYP2C8 Inhibitors

Hypolipidemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for gemfibrozil

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for gemfibrozil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	077836-001	Jul 27, 2006	AB	RX	No	No
Impax Pharms	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	078207-001	Jun 1, 2007	AB	RX	No	No
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074156-001	Oct 24, 1994		DISCN	No	No
Hikma Pharms	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	078599-001	Aug 16, 2010		DISCN	No	No
Purepac Pharm	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074360-001	Aug 31, 1994		DISCN	No	No

Expired US Patents for gemfibrozil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-001	Approved Prior to Jan 1, 1982	3,674,836
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982	3,674,836

Gemfibrozil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gemfibrozil

Introduction to Gemfibrozil

Gemfibrozil, a fibrate drug, is widely used to manage hyperlipidemia and hypertriglyceridemia by raising HDL-C (high-density lipoprotein cholesterol) levels and lowering triglyceride levels. Here, we delve into the market dynamics and financial trajectory of gemfibrozil, exploring its current market status, growth prospects, and cost-effectiveness.

Market Size and Growth Prospects

The gemfibrozil market is experiencing robust growth, driven by increasing prevalence of cardiovascular disorders and the need for effective lipid management.

• Global Market Size: The global fibrate drugs market, which includes gemfibrozil, was valued at USD 3.25 billion in 2023 and is projected to reach USD 5.41 billion by 2033, growing at a CAGR of 5.22% from 2024 to 2033[3].
• Segmentation: The market is segmented by drug type, product type (branded and generics), and distribution channels (hospital pharmacy, retail pharmacy, and online pharmacy). Gemfibrozil is a significant component of this market, particularly in regions like North America, where the U.S. fibrate drugs market alone is expected to grow from USD 890 million in 2023 to USD 1,510 million by 2033[3].

Market Dynamics

Drivers

• Increasing Prevalence of Cardiovascular Disorders: The rising incidence of cardiovascular diseases globally is a major driver for the gemfibrozil market. As more people are diagnosed with hyperlipidemia and hypertriglyceridemia, the demand for effective treatments like gemfibrozil increases[3].
• Cost-Effectiveness: Studies have shown that gemfibrozil is cost-effective, especially when purchased at negotiated prices. This makes it an attractive option for healthcare systems and patients alike[5].

Restraints

• Competition from Other Lipid-Lowering Drugs: The market for lipid-lowering drugs is highly competitive, with statins and other fibrates competing for market share. This competition can limit the growth of gemfibrozil sales[1].
• Side Effects and Safety Concerns: Like any medication, gemfibrozil has potential side effects and safety concerns, which can impact its adoption and market growth.

Opportunities

• Expanding into New Markets: Emerging markets in Asia-Pacific, Latin America, and the Middle East offer significant opportunities for growth. Increasing healthcare spending and awareness about cardiovascular health in these regions can drive demand for gemfibrozil[4].
• Generic Versions: The availability of generic versions of gemfibrozil can increase its accessibility and affordability, potentially expanding its market reach[3].

Challenges

• Regulatory Hurdles: Changes in regulatory policies and stringent approval processes can pose challenges to the market growth of gemfibrozil.
• Economic Factors: Economic downturns or changes in healthcare policies can affect the affordability and accessibility of gemfibrozil, impacting its sales[1].

Cost-Effectiveness and Financial Impact

Gemfibrozil has been shown to be cost-effective in several studies:

• VA-HIT Study: The VA-HIT study demonstrated that gemfibrozil reduces major cardiovascular events in patients with low HDL-C levels. Using VA-negotiated prices, gemfibrozil was found to be cost-saving, with a net lifetime cost savings of $110 per patient. Even at higher wholesale prices, the cost per quality-adjusted life-year (QALY) saved was between $6,300 and $17,100, which is well below the threshold for cost-effectiveness[5].
• Economic Analysis: The cost per year of life gained with gemfibrozil therapy is significantly lower than many other healthcare interventions. For instance, if the drug can be purchased for less than $100 per year (in 1998 prices), it results in a lifetime cost savings for CHD patients with low HDL-C levels[5].

Regional Market Analysis

• North America: This region is one of the largest markets for gemfibrozil, driven by high healthcare spending and a significant prevalence of cardiovascular diseases. The U.S. fibrate drugs market, which includes gemfibrozil, is projected to grow substantially from 2023 to 2033[3].
• Europe: Europe is another key market, with countries like Germany, France, and the UK contributing significantly to the demand for gemfibrozil. The region's well-established healthcare system and high awareness about cardiovascular health drive the market growth[4].
• Asia-Pacific: This region offers considerable growth potential due to its large population and increasing healthcare expenditure. Countries like China are expected to play a significant role in the future growth of the gemfibrozil market[4].

Competitive Landscape

The gemfibrozil market is competitive, with several major manufacturers involved:

• Key Players: Companies such as Parke-Davis (now part of Pfizer) and other generic manufacturers are key players in the market. The competitive landscape is further influenced by the presence of other fibrate drugs like clofibrate and fenofibrate[3][4].

Future Outlook

The future outlook for gemfibrozil is positive, driven by the increasing demand for lipid-lowering therapies and its proven cost-effectiveness.

• Market Expansion: The market is expected to expand significantly over the forecast period, driven by growing awareness about cardiovascular health and the need for effective treatments.
• Innovations and Generics: The availability of generic versions and potential innovations in delivery mechanisms or formulations could further enhance the market growth of gemfibrozil[1][3].

Key Takeaways

• Robust Market Growth: The gemfibrozil market is expected to grow significantly from 2023 to 2033, driven by the increasing prevalence of cardiovascular disorders.
• Cost-Effectiveness: Gemfibrozil is cost-effective, particularly when purchased at negotiated prices, making it an attractive option for healthcare systems.
• Regional Opportunities: North America, Europe, and Asia-Pacific are key regions driving the market growth, with emerging markets offering significant opportunities.
• Competitive Landscape: The market is competitive, with several major manufacturers and the presence of generic versions.

FAQs

Q: What is the projected market size of the gemfibrozil market by 2033? A: The global fibrate drugs market, which includes gemfibrozil, is projected to reach around USD 5.41 billion by 2033[3].

Q: How cost-effective is gemfibrozil in treating coronary heart disease? A: Gemfibrozil is cost-effective, with a cost per QALY saved ranging between $6,300 and $17,100, and it can result in lifetime cost savings if purchased at negotiated prices[5].

Q: Which regions are driving the growth of the gemfibrozil market? A: North America, Europe, and Asia-Pacific are the key regions driving the market growth, with North America being one of the largest markets[3][4].

Q: What are the main drivers of the gemfibrozil market? A: The main drivers include the increasing prevalence of cardiovascular disorders, cost-effectiveness, and expanding into new markets[3][4].

Q: Are there any challenges facing the gemfibrozil market? A: Yes, challenges include competition from other lipid-lowering drugs, side effects and safety concerns, regulatory hurdles, and economic factors[1][3].

Sources

1. Global Gemfibrozil Sales Market Size, Scope And Forecast Report - Market Research Intellect
2. Cost-effectiveness of gemfibrozil for coronary heart disease patients - PubMed
3. Fibrate Drugs Market Size to Worth USD 5.41 Billion by 2033 - Precedence Research
4. Global Gemfibrozil API Market Insights, Forecast to 2030 - QYResearch
5. Cost-effectiveness of Gemfibrozil for Coronary Heart Disease - JAMA Internal Medicine