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SYMLIN Drug Profile

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When do Symlin patents expire, and what generic alternatives are available?

Symlin is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-two patent family members in sixteen countries.

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

Summary for SYMLIN

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	17
Drug Prices:	see details
DailyMed Link:	SYMLIN at DailyMed

Pharmacology for SYMLIN

Drug Class	Amylin Analog
Mechanism of Action	Amylin Agonists

US Patents and Regulatory Information for SYMLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007		RX	Yes	No			Y	Y
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007		RX	Yes	Yes			Y	Y
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005		DISCN	No	No			Y	Y

Expired US Patents for SYMLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007

Non-Orange Book US Patents for 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
6,610,824	Amylin agonist peptides and uses therefor
7,271,238	Amylin agonist peptides and uses therefor
5,424,394	Synthetic preparation of amylin and amylin analogues
5,998,367	Pramlintide pro H-amylin salts and compositions

International Patents for SYMLIN

Country	Document Number	Estimated Expiration
Japan	2006213716
Slovakia	88793
Japan	H06504794
Australia	673147