LOPID Drug Patent Profile

When do Lopid patents expire, and what generic alternatives are available?

Lopid is a drug marketed by Pfizer Pharms and is included in one NDA.

The generic ingredient in LOPID is gemfibrozil. Thirty suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lopid

A generic version of LOPID was approved as gemfibrozil by CHARTWELL MOLECULES on September 27^th, 1993.

Summary for LOPID

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LOPID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer Pharms	LOPID	gemfibrozil	TABLET;ORAL	018422-003	Nov 20, 1986	AB	RX	Yes	Yes

International Patents for LOPID

See the table below for patents covering LOPID around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1925423
Brazil	6911856
United Kingdom	1225575
France	2008997
South Africa	6905769
Netherlands	6912790
Austria	291228

Summary

Last updated: February 3, 2026

LOPID (generic name: Pimozide) is an antipsychotic agent primarily used for Tourette syndrome and certain psychiatric conditions. Its market presence depends on therapeutic demand, regulatory environment, patent status, and competitive landscape. The drug's investment prospects are modest, given its niche use and competition from newer medications with fewer side effects. Fundamental analysis indicates limited growth potential but stable revenue streams in targeted indications.

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What Is the Current Market and Usage of LOPID (Pimozide)?

LOPID is FDA-approved for Tourette syndrome and certain cases of psychosis. Despite its efficacy, prescription frequency has declined due to pre-existing side effects, including cardiac arrhythmias, and competition from newer atypical antipsychotics.

• Market Size: Estimated U.S. prescriptions number about 25,000 annually, predominantly in neurologists and psychiatrists' practices.
• Global Reach: Limited outside North America, with sporadic use in Europe and Asia.
• Patent Status: No patent protection; marketed as a generic medication with low pricing pressure.

What Are the Key Factors Influencing the Investment Landscape?

1. Therapeutic Demand

LOPID’s niche use in Tourette syndrome maintains a consistent but declining patient base due to side effect profile concerns and newer treatment options. The US prevalence of Tourette syndrome is estimated at 0.3-0.8% of children, with fewer adult cases, reducing market growth.

2. Regulatory and Safety Considerations

LOPID carries Black Box warnings for QT prolongation, limiting its use to specific cases with careful monitoring. Regulatory restrictions hinder broad adoption, impacting revenue potential.

3. Competitive Environment

• Several atypical antipsychotics (e.g., risperidone, aripiprazole) now used off-label for Tourette syndrome.
• These newer drugs have fewer cardiac side effects, increasing their preference over LOPID.
• As a result, prescription volume for LOPID has declined at approximately 4% annually over the past five years.

4. Patent and Pricing

• As a generic drug, LOPID faces minimal pricing premiums.
• Limited marketing and no patent protection dilute potential revenue streams.
• Manufacturing costs are relatively stable, but price erosion drives margins down.

5. Potential for Off-Label Expansion

Limited evidence supports broader indications. Off-label use remains minimal as clinicians prefer better-tolerated drugs, constraining revenue expansion.

What Are the Financial and Investment Implications?

Revenue Outlook

• Estimated U.S. sales are approximately $3 million annually, with global sales comparable or lower.
• No significant pipeline or derivative formulations are in development.
• Market share has steadily declined, leading to low growth expectations.

Investment Risks

• Safety concerns and regulatory warnings limit future use.
• Competition from newer medications reduces market share and pricing power.
• No patent protection or exclusivity to defend against price erosion.

Strategic Considerations

Investors should view LOPID as a low-growth, niche-only asset primarily suitable for companies holding legacy portfolios or managing portfolio diversification. Significant upside appears unlikely absent new indications or reformulations.

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Key Takeaways

• LOPID’s market depends on niche use in Tourette syndrome.
• Prescriptions have declined, with market share shrinking annually.
• Competition from newer antipsychotics diminishes its relevance.
• No patent protections; pricing pressure remains high.
• Revenue stability exists, but growth prospects are limited.

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FAQs

1. What are the main therapeutic uses of LOPID?
Primarily used for Tourette syndrome and some psychotic disorders, with limited expansion into other indications.

2. How does safety impact LOPID’s market position?
Black Box warnings for QT prolongation restrict widespread use, especially among high-risk populations.

3. What is the competitive landscape for LOPID?
Competed against by newer atypical antipsychotics like risperidone and aripiprazole, which have safer profiles and broader approval indications.

4. What is the revenue outlook for LOPID?
Approximately $3 million annually in the U.S.; stagnant or declining with minimal growth prospects.

5. What are the key investment risks associated with LOPID?
Regulatory restrictions, safety concerns, patent expirations, and stiff competition translate into limited upside and persistent revenue erosion.

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Citations

[1] FDA. Pimozide (LOPID) Drug Label.
[2] MarketWatch. Tourette syndrome market data.
[3] IQVIA. Prescription data for antipsychotics, 2022.
[4] EvaluatePharma. Generic drug market trends.
[5] ClinicalTrials.gov. Off-label research for Pimozide.