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Last Updated: March 19, 2024

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 thirteen patents protecting this drug. Additional details are available on the BYDUREON BCISE profile page.

The generic ingredient in BYDUREON BCISE is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.
Summary for 209210
Tradename:BYDUREON BCISE
Applicant:Astrazeneca Ab
Ingredient:exenatide synthetic
Patents:13
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209210
Generic Entry Date for 209210*:
Constraining patent/regulatory exclusivity:
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 synthetic 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)

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:Jul 22, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 22, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Try a TrialPatent Expiration:Apr 4, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 209210

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.