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Generated: November 18, 2018

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Details for New Drug Application (NDA): 209210

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NDA 209210 describes BYDUREON BCISE, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the BYDUREON BCISE profile page.

The generic ingredient in BYDUREON BCISE is exenatide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide profile page.
Summary for 209210
Tradename:BYDUREON BCISE
Applicant:Astrazeneca Ab
Ingredient:exenatide
Patents:17
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209210
Generic Entry Date for 209210*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
SUSPENSION, EXTENDED RELEASE;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: 209210
Suppliers and Packaging for NDA: 209210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 NDA AstraZeneca Pharmaceuticals LP 0310-6540 0310-6540-04 4 CARTRIDGE in 1 CARTON (0310-6540-04) > .85 mL in 1 CARTRIDGE (0310-6540-01)
BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 NDA AstraZeneca Pharmaceuticals LP 0310-6540 0310-6540-85 1 CARTRIDGE in 1 CARTON (0310-6540-85) > .85 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUSStrength2MG/0.85ML (2MG/0.85ML)
Approval Date:Oct 20, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 20, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Aug 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 25, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 209210

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Cipla
Daiichi Sankyo
McKinsey
Mallinckrodt
Fish and Richardson
Argus Health
Dow

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