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Details for Generic Name: pramlintide acetate

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Pramlintide acetate is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for pramlintide acetate. Two suppliers are listed for this compound.

Summary for Generic Name: pramlintide acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packaging: see list6
Therapeutic Class:Blood Glucose Regulators

Pharmacology for Ingredient: pramlintide acetate

Drug ClassAmylin Analog
Mechanism of ActionAmylin Agonists

Clinical Trials for: pramlintide acetate

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;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNo5,814,600<disabled><disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNo5,686,411<disabled>YY<disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXNo5,814,600<disabled><disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXNo6,114,304<disabled><disabled>
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,686,411<disabled>YY<disabled>
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Non-Orange Book Patents for Generic Ingredient: pramlintide acetate

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
5,264,372 Receptor-based screening methods for amylin agonists and antagonists<disabled in preview>
5,795,861 Methods for regulating gastrointestinal motility<disabled in preview>
5,527,771 Methods and Compositions for treatment of diabetes mellitus, hypoglycemia & other conditions<disabled in preview>
5,508,260 Methods and compositions for treatment of diabetes mellitus, hypoglycemia, and other conditions<disabled in preview>
5,424,394 Synthetic preparation of amylin and amylin analogues<disabled in preview>
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International Patent Family for Ingredient: pramlintide acetate

Country Document Number Publication Date
Finland933252Aug 23, 1993
European Patent Office0533898Sep 02, 1998
Russian Federation2130463May 20, 1999
Spain2153828Mar 16, 2001
JapanH06510754Dec 01, 1994
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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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