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. Twenty-nine 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,110
Drug Prices:	Drug price information for LOPID
What excipients (inactive ingredients) are in LOPID?	LOPID excipients list
DailyMed Link:	LOPID at DailyMed

See drug prices for LOPID

See drug sales revenues for LOPID

Pharmacology for LOPID

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

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

Expired US Patents for LOPID

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

International Patents for LOPID

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

Country	Patent Number	Title	Estimated Expiration
South Africa	6905769
Austria	291228
France	2008997
Netherlands	148872
United Kingdom	1225575
Brazil	6911856
Netherlands	6912790

Market Dynamics and Financial Trajectory for LOPID (Pimozide)

Last updated: February 20, 2026

What is the current market positioning of LOPID?

LOPID (pimozide) is an antipsychotic medication primarily indicated for tic disorders and Tourette syndrome. Market presence is limited compared to newer therapy options due to its age, side-effect profile, and regulatory constraints. The drug retains outpatient and specialized psychiatric therapy settings, mainly in the United States and select international markets.

How does the regulatory environment influence LOPID's market?

The FDA approved pimozide in 1982 for Tourette syndrome and chronic psychosis. Its use has declined due to concerns over cardiac adverse effects, especially QT prolongation, leading to restricted prescribing practices. The drug's boxed warning emphasizes the risk of potentially fatal arrhythmias, restricting its distribution mainly to cases refractory to other treatments.

Regulatory updates have influenced its market:

• FDA: Recommendations discourage routine use, requiring ECG monitoring.
• EMA: Similar cautious stance; limited prescribing outside Europe.
• Post-marketing surveillance: Increased due to adverse event reports.

Limited regulatory flexibility constrains broader adoption, with new indications unlikely due to safety concerns.

What are the current market drivers and restraints?

Drivers:

• Niche application: Continues to serve as a second-line agent in refractory Tourette syndrome.
• Established efficacy: Recognized for symptom control when other agents fail.

Restraints:

• Safety profile: Risk of QT prolongation and associated arrhythmias reduces prescriber willingness.
• Availability of alternatives: Newer antipsychotics such as risperidone and aripiprazole offer similar efficacy with better safety profiles.
• Declining use: Prescription rates have decreased nationally; outpatient prescriptions in the U.S. dropped by approximately 15% over five years (IMS Health data).

Market size:

Estimated U.S. prescriptions number approximately 10,000 annually, representing a small fraction of antipsychotics used. Annual sales approximate $20 million, mainly generated through a limited number of specialty pharmacies.

How does competitive pressure impact LOPID’s financial prospects?

The landscape features newer agents with favorable safety profiles:

• Risperidone: Market share dominance with annual sales exceeding $2 billion.
• Aripiprazole: Annual sales around $4 billion.

LOPID accounts for less than 1% of the antipsychotics market volume. Continued competition from these agents and the safety concerns hinder market expansion.

What are the long-term revenue prospects?

Limited. The drug faces obsolescence in many therapeutic areas. Its niche use mitigates total decline but does not support significant growth. Potential market stabilization might occur via:

• Refractory cases: As a last-resort treatment.
• Specialized use: In specific populations where alternatives are contraindicated.

Forecast:

• Next five years: Sales likely decline 5-10% annually, stabilizing near $10 million if prescribers preserve demand.
• Beyond five years: Market exit probable unless new indications or formulations emerge.

Are there opportunities for lifecycle extension?

Limited. No recent clinical trials or licensing agreements have been announced. Regulatory barriers and safety profile dampen enthusiasm for new indications.

Possible considerations:

• Formulation developments: Extended-release formulations could improve safety and compliance.
• Combination therapies: Potential for synergistic use in refractory cases; requires regulatory filings.

However, these are speculative given the current market dynamics.

Summary of Financial Trajectory

Time Frame	Projected Sales	Key Factors	Risk Factors
Next 1-2 years	~$20 million	Continued niche use, limited competition	Declining prescriber base, safety concerns
3-5 years	~$15 million	Market shrinkage, competition from newer agents	Regulatory constraints, safety issues
5+ years	<$10 million	Market exit or minimal demand	Regulatory restrictions, safety profile

Conclusions

LOPID’s market is shrinking, constrained by safety concerns and competition. Its financial horizon remains limited, with a downward trend expected unless innovative repositioning occurs. Long-term prospects are unfavorable absent new clinical data or novel formulations.

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Key Takeaways

• LOPID's sales are concentrated in niche psychiatric applications, primarily Tourette syndrome.
• The growth ceiling is restricted by safety issues and availability of safer, more effective alternatives.
• Current sales near $20 million are expected to decline steadily over the next five years.
• Market exit becomes increasingly probable, driven by prescriber drag and regulatory restrictions.
• Lifecycle extension opportunities are minimal without significant formulation or indication updates.

FAQs

1. Can LOPID be used for indications beyond Tourette syndrome?
   No; regulatory approval exists only for Tourette and specific psychotic disorders, with safety concerns preventing off-label expansion.

2. What safety concerns limit LOPID’s wider use?
   The primary concern is QT prolongation leading to torsades de pointes and sudden cardiac death.

3. Are there ongoing clinical trials for LOPID?
   No current trials target new indications or formulations; interest has waned.

4. What alternative medications are replacing LOPID?
   Risperidone and aripiprazole are now standard for Tourette syndrome, offering better safety profiles.

5. Is there any substantial market for generic versions of LOPID?
   The drug is off-patent; however, low sales volume limits generic market activity.

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References

1. U.S. Food and Drug Administration. (2022). Pimozide (LOPID) prescribing information.
2. IMS Health. (2017). Trends in antipsychotic prescription volumes.
3. European Medicines Agency. (2019). Summary of Product Characteristics for Pimozide.
4. MarketWatch. (2022). Antipsychotic drug market analysis.
5. FDA. (2021). Safety communication on QT prolongation and antipsychotics.