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, Pharmobedient, 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.

Twenty-nine 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:	29
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	48
Patent Applications:	7,551
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
Forest Hills Lab	PHASE2
Hoffmann-La Roche	PHASE1
Vertex Pharmaceuticals Incorporated	PHASE1

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
Watson Labs	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074156-001	Oct 24, 1994		DISCN	No	No
Pharmobedient	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	074452-001	Feb 16, 1995		DISCN	No	No
Cadila	GEMFIBROZIL	gemfibrozil	TABLET;ORAL	204189-001	Aug 28, 2018		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
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Gemfibrozil

Last updated: February 19, 2026

What Is the Current Market Position of Gemfibrozil?

Gemfibrozil is a fibrate class drug approved for lowering triglycerides and raising HDL cholesterol levels. Originally marketed by Bristol-Myers Squibb, its patent expired in the early 2000s. Since then, generic versions proliferated, leading to significant price reduction and market saturation.

Market estimates suggest the global value of gemfibrozil and its generics hovered around $60 million in 2022. That figure encompasses sales in North America, Europe, and parts of Asia, mainly driven by prescriptions for dyslipidemia management.

How Has the Patent Expiry Affected Market Dynamics?

Patent expiration in 2003 triggered a sharp decline in branded sales and paved the way for generics. Market share shifted almost entirely to generic manufacturers, which offer equivalent efficacy at a lower price point. This transition resulted in a rapid drop in drug prices, often by 70-80% within two years of patent loss.

The replacement of gemfibrozil with newer agents like fenofibrate and omega-3 fatty acids further constrained demand, especially as guidelines shifted towards combination therapies and alternative lipid-lowering agents.

What Are the Key Drivers and Barriers in the Market?

Drivers

• Rising prevalence of dyslipidemia worldwide, especially in aging populations.
• Cost-effective profile due to generic availability.
• Established efficacy for triglyceride reduction in clinical practice.

Barriers

• Availability of newer, more potent lipid-lowering drugs with better safety profiles.
• Limited patent protections optimize generic competition, limiting profit margins.
• Regulatory shifts favoring combination therapies that reduce monotherapy relevance.

How Do Regulatory and Policy Frameworks Impact the Trajectory?

Regulatory agencies like the U.S. FDA facilitate the entry of generics via abbreviated approval pathways, which accelerates market saturation. The U.S. FDA's bioequivalence requirements mean generic gemfibrozil companies can achieve market entry with significantly lower R&D costs, keeping prices low.

Health policies advocating for cost-saving drug utilization bolster the generic market, further diminishing the revenue potential for branded products.

What Is the Future Financial Outlook?

The global market for gemfibrozil and its generics is expected to decline slowly, with projections suggesting a compound annual growth rate (CAGR) of -2% from 2022 to 2027. Contributing factors include:

• Market saturation.
• Competitive pressure from newer lipid agents.
• Declining prescription volumes for monotherapy.

Despite declining volumes, the low price point of generics sustains modest revenues. Manufacturers focusing on niche markets or seeking to extend drug indications might find opportunities to preserve revenue streams.

How Do Competitive Alternatives Affect Market and Revenue?

Newer agents such as fenofibrate, pemafibrate, and omega-3 fatty acids maintain or grow market share in hyperlipidemia treatment. These options often have better lipid modulation, fewer side effects, or additional benefits, which limits gemfibrozil’s growth prospects.

Combination therapies and updated clinical guidelines increasingly favor these alternatives, reducing gemfibrozil's position even further.

What Are the Regulatory Trends Influencing the Market?

Regulations favor generic entry post-patent expiry. The approval process involves demonstrating bioequivalence, which is less costly than new drug development. This regulatory environment discourages investment in reformulation or new indications for gemfibrozil, constraining long-term growth.

Summary Table: Market Data and Projections

Parameter	2022	2027 (projected)	Notes
Global sales	~$60 million	~$50 million	Declining trend due to market saturation
CAGR	N/A	-2%	Market decline rate
Patent status	Expired (2003)	N/A	No patent protection in key markets
Main competitors	Fenofibrate, omega-3s	Same	Market share shifting

Key Takeaways

• Gemfibrozil's patent expiry in 2003 led to immediate revenue decline.
• Generics dominate global sales, with prices reducing significantly post-patent loss.
• Competition from newer lipid-lowering drugs constrains growth.
• The global market is shrinking, with a CAGR of -2% expected through 2027.
• Regulatory pathways facilitate generic entry, hindering branded drug rebound opportunities.

FAQs

1. Why did gemfibrozil lose market share?
Patents expired in 2003, allowing generics to enter with lower prices. Newer drugs with improved safety and efficacy gained favor, reducing gemfibrozil’s market share.

2. Are there any new indications for gemfibrozil?
No significant new indications have been approved since patent expiry. The focus remains on its original use for dyslipidemia.

3. How does the price trend of gemfibrozil look?
Prices have declined approximately 70-80% since patent expiry, stabilizing at low levels due to generic competition.

4. Is there any ongoing R&D for gemfibrozil?
No substantial R&D efforts are reported; the market's saturation discourages investment in reformulation or novel uses.

5. How do clinical guidelines impact gemfibrozil's market?
Guidelines favor newer fibrates and combination therapies, leading to reduced prescribing of gemfibrozil monotherapy.

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Citations

[1] U.S. Food and Drug Administration. (2023). Generic drug approval process. Retrieved from https://www.fda.gov/drugs/generic-drugs
[2] MarketWatch. (2022). Global Lipid-Lowering Drugs Market Size & Trends.
[3] IQVIA. (2022). Market Analysis of Hyperlipidemia Treatments.