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MERIDIA

NDA

SIBUTRAMINE HYDROCHLORIDE | N020632 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Public Citizen Health Research Group - Citizen Petition FDA-2009-P-0595 · 6 docket documents Public Citizen Health Research Group, directed by Sidney Wolff, M.D., filed this petition on December 3, 2009, requesting that the FDA immediately ban sibutramine (Meridia, marketed by Abbott) for weight loss. The petition cited results from the SCOUT study, a large randomized controlled trial manda	Other	2009-12-17	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

31 trials from ClinicalTrials.gov, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Binge Eating in Obese Patients in Primary Care NCT00537810	Phase 4	Completed	Yale University	104	2007-09 → 2012-10
A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects NCT01597609	Phase 1	Completed	GlaxoSmithKline	60	2008-05-22 → 2010-03-04
Effects of Weight Loss in Obese Difficult-to-treat Asthmatics NCT01047657	Phase 3	Completed	University of Sao Paulo General Hospital	33	2009-11 → 2010-12
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects NCT00134199	Phase 2/3	Completed	Pfizer	282	2005-03 → 2005-11
Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients NCT00729963	Phase 4	Completed	Laval University	45	2004-01 → 2007-09
Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS NCT00463112	Phase 4	Completed	Hippocration General Hospital	80	2004-03 → 2006-09
Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine NCT01184560	N/A	Completed	Gachon University Gil Medical Center	174	2010-02 → 2010-07
Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care NCT00829283	N/A	Completed	Yale University	191	2008-11 → 2013-11
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.NCT00234988	Phase 4	Completed	Abbott	93	2004-06
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects NCT00402077	Phase 2	Completed	AstraZeneca	258	2006-11 → 2007-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs6 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPAInactiveSIBUTRAMINE HYDROCHLORIDE ANHYDROUS

DMF 171712004

MYLAN LABORATORIES LTDInactiveSIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

DMF 179772005

DIVIS LABORATORIES LTDInactiveSIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

DMF 197292006

CIPLA LTDInactiveSIBUTRAMINE HYDROCHLORIDE

DMF 201612007

SREENIVASA PHARMA PRIVATE LTDInactiveSIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

DMF 223732009

SYMED LABS LTDInactiveSIBUTRAMINE HYDROCHLORIDE MONOHYDRATE

DMF 229212009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Aug 10, 2010	SUPPL -35	View Letter (PDF)
Aug 10, 2010	SUPPL -34	View Letter (PDF)
May 6, 2009	SUPPL -32	View Letter (PDF)
Dec 30, 2008	SUPPL -31	View Letter (PDF)
May 30, 2008	SUPPL -30	View Letter (PDF)
Sep 18, 2006	SUPPL -26	View Letter (PDF)
Dec 15, 2005	SUPPL -21	View Letter (PDF)
Aug 3, 2005	SUPPL -24	View Letter (PDF)
Dec 2, 2004	SUPPL -20	View Letter (PDF)
Dec 2, 2004	SUPPL -19	View Letter (PDF)
Sep 30, 2003	SUPPL -17	View Letter (PDF)
Feb 16, 2001	SUPPL -11	View Letter (PDF)
Feb 16, 2001	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 22, 1997

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 22, 1997

#003 — 15MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 22, 1997