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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021332

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NDA 021332 describes SYMLIN, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SYMLIN profile page.

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 021332
Tradename:SYMLIN
Applicant:Astrazeneca Ab
Ingredient:pramlintide acetate
Patents:1
Generic Entry Opportunity Date for 021332
Generic Entry Date for 021332*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021332
Mechanism of ActionAmylin Agonists
Suppliers and Packaging for NDA: 021332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332 NDA AstraZeneca Pharmaceuticals LP 0310-6615 0310-6615-02 2 CARTRIDGE in 1 CARTON (0310-6615-02) > 1.5 mL in 1 CARTRIDGE
SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332 NDA AstraZeneca Pharmaceuticals LP 0310-6627 0310-6627-02 2 CARTRIDGE in 1 CARTON (0310-6627-02) > 2.7 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)
Approval Date:Mar 16, 2005TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)
Approval Date:Sep 25, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
Approval Date:Sep 25, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN

Expired US Patents for NDA 021332

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

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