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Profile for Tradename: CYCLOSET

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Cycloset is a drug marketed by Veroscience and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug.

This drug has one hundred and fifteen patent family members in twenty-six countries.

The generic ingredient in CYCLOSET is bromocriptine mesylate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for Tradename: CYCLOSET

Patents:8
Applicants:1
NDAs:1
Suppliers: see list1

Pharmacology for Tradename: CYCLOSET

Ingredient-typeErgolines
Drug ClassErgot Derivative

Clinical Trials for: CYCLOSET

Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects
Status: Recruiting Condition: Type 2 Diabetes

Effect of Cycloset on Glycemic Control When Added to GLP-1 Analogue Therapy
Status: Recruiting Condition: Type 2 Diabetes

Bromocriptine and Insulin Sensitivity
Status: Recruiting Condition: Insulin Sensitivity

Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

Vaginal Bromocriptine for Treatment of Adenomyosis
Status: Active, not recruiting Condition: Adenomyosis

Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study
Status: Not yet recruiting Condition: PCOS; Insulin Resistance

Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease
Status: Recruiting Condition: Parkinson's Disease

Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
Status: Recruiting Condition: Peripartum Cardiomyopathy

QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes8,137,993<disabled><disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes7,888,310<disabled><disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes5,716,957<disabled><disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes8,431,155<disabled>Y<disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes8,137,992<disabled><disabled>
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Non-Orange Book Patents for Tradename: CYCLOSET

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,731,312 Process for the long term reduction of body fat stores, insulin resistance, hyperinsulinemia and hyperglycemia in vertebrates<disabled in preview>
5,872,127 Method of regulating immune function<disabled in preview>
5,496,803 Process for the long term reduction of body fat stores, insulin resistance, hyperinsulinemia in vertebrates<disabled in preview>
5,554,623 Method for the long term reduction of body fat stores, insulin resistance, hypersinsulinemia and hyperglycemia in vertebrates<disabled in preview>
5,719,160 Method for modifying and regulating lipid metabolism<disabled in preview>
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International Patent Family for Tradename: CYCLOSET

Country Document Number Publication Date
Mexico9700225Apr 30, 1997
Spain2210305Jul 01, 2004
Spain2333848Mar 02, 2010
European Patent Office0772396May 14, 1997
Austria440606Sep 15, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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