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Profile for Tradename: SYMLIN

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Symlin is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug.

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

The generic ingredient in SYMLIN is pramlintide acetate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pramlintide acetate profile page.

Summary for Tradename: SYMLIN

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: SYMLIN

Drug ClassAmylin Analog
Mechanism of ActionAmylin Agonists

Clinical Trials for: SYMLIN

A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Status: Completed Condition: Type 1 Diabetes Mellitus

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes
Status: Recruiting Condition: Type 2 Diabetes

Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Status: Completed Condition: Type 1 Diabetes

Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
Status: Active, not recruiting Condition: Type 2 Diabetes Mellitus

An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Status: Completed Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Status: Completed Condition: Overweight; Obesity

A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes
Status: Withdrawn Condition: Type 1 Diabetes

A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes
Status: Completed Condition: IDDM

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
Status: Completed Condition: Overweight; Obesity

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXNo5,686,411<disabled>YY<disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,686,411<disabled>YY<disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,814,600<disabled><disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNo5,814,600<disabled><disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXNo5,814,600<disabled><disabled>
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Non-Orange Book Patents for Tradename: SYMLIN

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
6,608,029 Methods for regulating gastrointestinal motility<disabled in preview>
5,264,372 Receptor-based screening methods for amylin agonists and antagonists<disabled in preview>
5,234,906 Hyperglycemic compositions<disabled in preview>
5,424,394 Synthetic preparation of amylin and amylin analogues<disabled in preview>
5,321,008 Methods and compositions for treatment of diabetes mellitus, hypoglycemia, and other conditions<disabled in preview>
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International Patent Family for Tradename: SYMLIN

Country Document Number Publication Date
Israel120082Apr 15, 1997
Australia1328692Aug 17, 1992
JapanH06504794Jun 02, 1994
European Patent Office0717635Jun 26, 1996
Norway20073265Sep 17, 1993
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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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