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:	108
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
AstraZeneca	Phase 4
New York State Psychiatric Institute	Phase 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997

International Patents for MERIDIA

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

Country	Patent Number	Title	Estimated Expiration
India	163129	A PROCESS FOR PREPARING N,N-DIMETHYL-1-(1-(4-CHLOROPHENYL)CYCLOBUTYL)-3-METHYLBUTYLAMINE HYDROCHLORIDE MONOHYDRATE
Cyprus	1408	THERAPEUTIC AGENTS
New Zealand	218578	N,N-DIMETHYL-1-(1-(4-CHLOROPHENYL)CYCLOBUTYL)-3-METHYL BUTYLAMINE HYDROCHLORIDE MONOHYDRATE AND PHARMACEUTICAL COMPOSITIONS
Denmark	170770

Supplementary Protection Certificates for MERIDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	34/2001	Austria		PRODUCT NAME: SIBUTRAMINHYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-24052, 1-24053 20010423; FIRST REGISTRATION: LI 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

MERIDIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Meridia (Sibutramine)

Introduction

Meridia, known generically as sibutramine, was once a widely prescribed drug for the management of obesity. However, its market trajectory was significantly impacted by safety concerns, leading to its eventual withdrawal from many markets.

Approval and Initial Market Presence

FDA Approval

Meridia was approved by the U.S. Food and Drug Administration (FDA) in November 1997 for weight loss and maintenance of weight loss in patients with a body mass index (BMI) of 30 kg/m² or higher, or 27 kg/m² or higher with other risk factors such as diabetes, dyslipidemia, or controlled hypertension[1][3].

Market Position

At the time of its approval, Meridia was seen as a promising addition to the obesity treatment market. It was marketed by Abbott Laboratories and sold under various brand names including Meridia, Reductil, Siredia, and Sibutrex[5].

Safety Concerns and Regulatory Actions

Cardiovascular Risks

The turning point for Meridia came with the release of data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial. This trial revealed a 16% increase in the risk of major adverse cardiovascular events, including non-fatal heart attacks, non-fatal strokes, resuscitation after cardiac arrest, and cardiovascular death, compared to patients taking a placebo[1].

FDA Recommendation and Market Withdrawal

In response to these findings, the FDA recommended against the continued use of Meridia and requested that Abbott Laboratories voluntarily withdraw the drug from the U.S. market. Abbott agreed to this request, and Meridia was withdrawn from the market in 2010[1].

Impact on the Obesity Drug Market

Market Rearrangement

The withdrawal of Meridia significantly altered the landscape of the obesity drug market. Other drugs like Orlistat (sold as Alli and Xenical by GlaxoSmithKline and Roche, respectively) and medical alternatives like the Lap-Band by Allergan became the primary options for patients seeking weight loss treatments[2].

Financial Implications

The removal of Meridia from the market had financial implications for both Abbott Laboratories and the broader obesity drug market. Analysts had previously projected significant revenues from obesity drugs, but the reality was much lower. For example, projections for drugs like Arena's Lorqess and Vivus's Qnexa were highly optimistic but ultimately unrealized due to FDA rejections and safety concerns[2].

Current Market and Future Projections

Shift in Obesity Treatment

Despite the setbacks with Meridia and other early obesity drugs, the market for obesity treatments has seen a significant resurgence. New drugs have been developed, and there is a growing recognition of obesity as a chronic disease rather than just a lifestyle issue. This shift has led to increased investment and research in obesity medications[4].

Financial Projections

The global market for obesity drugs is expected to expand dramatically, with projections suggesting it could reach $105 billion by 2030, up from $6 billion in 2023. This growth is driven by the increasing demand for effective obesity treatments and the potential for these drugs to address a wide range of obesity-related illnesses[4].

Lessons Learned and Future Directions

Safety and Efficacy

The story of Meridia highlights the importance of rigorous safety and efficacy trials. The drug's initial promise was overshadowed by its cardiovascular risks, leading to its withdrawal. Future obesity drugs must undergo thorough testing to ensure they are safe and effective[1][5].

Market Adaptation

The obesity drug market has adapted to the failures of the past by focusing on newer, safer treatments. This includes a broader range of therapeutic options and a greater emphasis on lifestyle changes supported by medication[4].

Key Takeaways

• Meridia was withdrawn from the market due to increased cardiovascular risks.
• The withdrawal significantly impacted the obesity drug market, leading to a rearrangement of available treatments.
• Despite early setbacks, the market for obesity drugs is now expected to grow substantially.
• Safety and efficacy remain critical factors in the development and approval of new obesity treatments.
• The future of obesity drugs lies in their potential to treat a wide range of related illnesses and improve overall health outcomes.

FAQs

Q: Why was Meridia withdrawn from the market?

A: Meridia was withdrawn due to a 16% increase in the risk of major adverse cardiovascular events compared to patients taking a placebo, as revealed by the SCOUT trial[1].

Q: What were the primary uses of Meridia?

A: Meridia was used for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced-calorie diet[3].

Q: How did the withdrawal of Meridia affect the obesity drug market?

A: The withdrawal led to a rearrangement of the market, with other drugs like Orlistat and medical alternatives like the Lap-Band becoming primary options for patients[2].

Q: What are the current projections for the obesity drug market?

A: The global market for obesity drugs is projected to reach $105 billion by 2030, driven by increasing demand and the potential for these drugs to address various obesity-related illnesses[4].

Q: What lessons can be learned from the Meridia experience?

A: The importance of rigorous safety and efficacy trials is highlighted by Meridia's story. Future drugs must undergo thorough testing to ensure safety and effectiveness[1][5].

Sources

1. FDA Recommends Against the Continued Use of Meridia - FDA
2. With Meridia Gone, Can't We Just Admit There's No Money in Diet Drugs? - CBS News
3. Meridia (Sibutramine Hydrochloride Monohydrate) - RxList
4. Scaling Up the Impact of Obesity Drugs - Morgan Stanley
5. Sibutramine - Wikipedia