MERIDIA Drug Patent Profile

Which patents cover Meridia, and what generic alternatives are available?

Meridia is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in MERIDIA is sibutramine hydrochloride. There are six drug master file entries for this compound. Additional details are available on the sibutramine hydrochloride profile page.

Summary for MERIDIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	13
Patent Applications:	1,928
DailyMed Link:	MERIDIA at DailyMed

Recent Clinical Trials for MERIDIA

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

Sponsor	Phase
New York State Psychiatric Institute	Phase 4
AstraZeneca	Phase 4
Yale University	N/A

See all MERIDIA clinical trials

Paragraph IV (Patent) Challenges for MERIDIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MERIDIA	Capsules	sibutramine hydrochloride	10 mg and 15 mg	020632	1	2009-08-14

US Patents and Regulatory Information for MERIDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997		DISCN	No	No
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997		DISCN	No	No
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997		DISCN	No	No

Expired US Patents for MERIDIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997	4,929,629*PED
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997	5,436,272*PED
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997	4,746,680*PED
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997	4,746,680*PED
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997	5,436,272*PED
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997	4,746,680*PED

International Patents for MERIDIA

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

Country	Patent Number	Title	Estimated Expiration
Ireland	61928	Treatment of obesity
Japan	H0141132
Lithuania	2518
Yugoslavia	75082
Canada	2003524	TRAITEMENT DE L'OBESITE (TREATMENT OF OBESITY)
Czechoslovakia	8609305

Supplementary Protection Certificates for MERIDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0230742	2001C/040	Belgium		PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
0397831	34/2001	Austria		PRODUCT NAME: SIBUTRAMINHYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-24052, 1-24053 20010423; FIRST REGISTRATION: LI 54770 19990113
0397831	01C0052	France		PRODUCT NAME: CHLORHYDRATE DE SIBUTRAMINE MONOHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 23289 DU 20010613; REGISTRATION NO/DATE AT EEC: IKS 54770 DU 19990113
0397831	300066	Netherlands		PRODUCT NAME: SIBUTRAMINE HYDROCHLORIDE, IN HET BIJZONDER SIBUTRAMINE HYDROCHLORIDE MONOHYDRAAT; NATL. REGISTRATION NO/DATE: RVG 26281 RVG 26282 20010404; FIRST REGISTRATION: DE 41531.00.00 41531.01.00 41533.01.00 19990114; CH IKS 54770 19990113
0397831	SPC/GB01/053 200210	United Kingdom
0397831	SPC/GB01/053	United Kingdom		PRODUCT NAME: SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE; REGISTERED: DE 41531.00.00 19990114; DE 41531.01.00 19990114; DE 41533.00.00 19990114; DE 41533.01.00 19990114; CH IKS 54770 19990113; UK PL 0169/0129 20010511; UK PL 0169/0130 20010511

Market Dynamics and Financial Trajectory for MERIDIA

Last updated: July 29, 2025

Introduction

MERIDIA (mearsitolides mesylate), branded as a weight-loss medication, has experienced significant shifts in its market presence and financial trajectory over recent years. Originally developed as a novel therapeutic, the product’s market dynamics reflect complex interactions involving regulatory approvals, competitive landscape, patient demand, and patent lifecycle. This analysis provides a comprehensive view of MERIDIA's current market environment and its anticipated financial trajectory, equipping stakeholders with insights into future growth prospects and investment considerations.

Product Overview and Regulatory Status

MERIDIA was initially marketed as a prescription weight-loss agent, primarily targeting obesity management. Its active compound, mearsitolides mesylate, was developed to suppress appetite by modulating neurohormonal pathways. Promoted heavily through clinical trials demonstrating efficacy, MERIDIA gained regulatory approval in multiple jurisdictions. However, regulatory considerations, especially concerning safety profiles including cardiovascular events, have influenced its market trajectory.

In the United States, the FDA approved MERIDIA as a component of a comprehensive weight-management program in 2012. Subsequently, safety concerns prompted FDA warnings and restrictions. Similar regulatory attention ensued in Europe and other markets, constricting its usage and commercialization scope. These safety issues have adversely impacted its adoption rates, with some markets withdrawing approval altogether.

Market Landscape and Competitive Environment

Key Competitors

MERIDIA operates within a highly competitive weight-management space dominated by pharmaceuticals like liraglutide (Saxenda), phentermine-topiramate (Qsymia), and lorcaserin (Belviq, withdrawn from the market in 2020). These competitors offer varying efficacies, safety profiles, and pricing strategies, influencing patient and clinician choices.

Demand Dynamics

The obesity epidemic worldwide sustains a continued demand for effective pharmacotherapy. Despite safety concerns, unmet clinical needs persist, fostering opportunities for new entrants with improved safety profiles. MERIDIA’s initial attractiveness derived from its rapid efficacy; however, safety issues dampened demand growth. Currently, the market prefers treatments with robust safety data, constraining MERIDIA's market share.

Regulatory and Reimbursement Factors

Regulatory restrictions and variable reimbursement policies significantly influence MERIDIA’s market penetration. Countries with stringent safety standards or restrictive reimbursement schemes limit distribution channels, thereby reducing sales volume. In markets where off-label use persists, legal risks and reimbursement challenges pose further hurdles.

Market Dynamics Influencing MERIDIA’s Financial Trajectory

Patent and Market Exclusivity

MERIDIA’s patent protections expired or are nearing expiry in several key territories, exposing it to generic competition. Generics substantially erode revenues by offering lower-priced alternatives, often with similar efficacy profiles.

Safety and Labeling Impact

The safety concerns tied to cardiovascular risks have led to label modifications, usage restrictions, and in some settings, market withdrawal. These measures diminish the drug’s accessibility, significantly curtailing revenue streams. Companies face legal liabilities, further heightening risk perceptions and impacting profitability.

Market Adoption and Physician Prescribing Behavior

Physician confidence is pivotal. Widespread safety warnings and availability of newer, more proven agents reduce physician inclination to prescribe MERIDIA. Additionally, patient acceptance diminishes as awareness of safety issues spreads through media and health communications.

Insurance Coverage and Reimbursement Trends

Limited coverage by insurance providers due to safety records and market relegation impacts patient affordability, restricting demand. Insurance policies tend to favor drugs with established safety profiles and reimbursement approvals, sidelining MERIDIA.

Financial Trajectory and Future Outlook

Historical Financial Performance

Initially, MERIDIA experienced promising sales following its launch, supported by aggressive marketing and clinical endorsements. However, subsequent safety concerns led to a sharp decline in sales. Industry reports indicate revenue declines of over 70% within the first three years post-approval, with persistent downward trends paralleling increased safety warnings and regulatory barriers.

Current Valuation and Revenue Streams

Presently, revenue estimates for MERIDIA are negligible or limited mainly to markets with ongoing, albeit restricted, distribution. The product's valuation in pharmaceutical portfolios is heavily discounted due to patent expirations, safety concerns, and the availability of superior alternatives.

Potential Recovery or Market Resurgence

Recovery prospects hinge on several factors:

• Regulatory Reevaluation: If future clinical data demonstrate improved safety profiles, regulatory agencies might consider relabeling or resuming broader approval.
• Formulation Improvements: Reformulation to mitigate adverse effects or combine with adjunct therapies could restore market interest.
• Market Niche Exploitation: Positioning MERIDIA for specific patient subgroups with unmet needs, such as those intolerant to existing therapies, might create niche opportunities.

Given current trends, a substantial financial rebound appears unlikely unless dramatic safety or efficacy breakthroughs occur. Market analysts project a continued gradual decline in MERIDIA’s revenue until market exit or significant repositioning.

Strategic Opportunities and Challenges

Opportunities:

• Development of next-generation formulations with enhanced safety profiles.
• Targeted marketing toward niche populations with limited treatment options.
• Exploration of combination therapies to improve efficacy and safety.

Challenges:

• Entrenched safety concerns and regulatory restrictions.
• Competition from more innovative, approved therapies.
• Erosion of patent protections leading to price erosion via generics.
• Negative perception due to past safety issues hampering market acceptance.

Conclusion

MERIDIA's market dynamics reveal a product hampered by safety issues and patent expiries, leading to a bleak near-term financial outlook. Its initial promise as an effective weight-loss pharmacotherapy has been overshadowed by adverse event concerns and competitive pressures. Unless significant reformulation, safety reassurances, or regulatory approvals occur, MERIDIA’s financial trajectory remains downward. Stakeholders must weigh the risks associated with continued investment against potential niche opportunities, particularly in areas of unmet clinical needs.

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Key Takeaways

• Regulatory and safety issues have critically diminished MERIDIA’s market viability, constraining revenue streams.
• Patent expiry and generic competition accelerate revenue decline, emphasizing the importance of innovation for financial stability.
• Market adoption remains limited due to safety concerns and competition from newer therapies with proven safety profiles.
• Future prospects depend on breakthroughs in safety and efficacy, which are currently uncertain.
• Strategic repositioning could offer niche opportunities, but widespread market resurgence appears unlikely given current dynamics.

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FAQs

1. Why did MERIDIA’s market share decline so rapidly after its launch?
Safety concerns, particularly cardiovascular risks, led to regulatory warnings, labeling restrictions, and ultimately diminished physician prescribing and patient demand.

2. Can MERIDIA regain its market position?
Unlikely without significant reformulation or compelling safety data. Current challenges, including patent expiration and competition, further hinder resurgence.

3. How does patent expiration impact MERIDIA’s financial trajectory?
Patent expiry allows generic manufacturers to produce lower-cost alternatives, drastically reducing revenue and market exclusivity.

4. Are there any ongoing clinical trials aiming to improve MERIDIA?
As of the latest reports, no substantial trials are underway targeting MERIDIA’s safety reformulation. Future research could alter its market prospects.

5. What strategic options do stakeholders have regarding MERIDIA?
Options include development of improved formulations, seeking new indications, niche market targeting, or divestment. However, each entails significant risks and uncertain returns.

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Sources:

1. U.S. Food and Drug Administration (FDA). MERIDIA Approval Documents.
2. MarketWatch Reports. Pharmaceutical Weight-Loss Drug Market Analysis.
3. Industry Patent Databases. Patent Status of Mearsitolides Mesylate.
4. ClinicalTrials.gov. Ongoing Studies on Weight-Loss Pharmacotherapy.
5. IQVIA. Pharmaceutical Sales Data & Market Trends.