.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022200

« Back to Dashboard
NDA 022200 describes BYDUREON PEN, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are twenty patents protecting this drug. Additional details are available on the BYDUREON PEN profile page.

The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for NDA: 022200

Tradename:
BYDUREON
Applicant:
Astrazeneca Ab
Ingredient:
exenatide synthetic
Patents:20
Formulation / Manufacturing:see details

Pharmacology for NDA: 022200

Suppliers and Packaging for NDA: 022200

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 NDA AstraZeneca Pharmaceuticals LP 0310-6520 0310-6520-04 4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 NDA AstraZeneca Pharmaceuticals LP 0310-6520 0310-6520-04 4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUSStrength2MG/VIAL
Approval Date:Jan 27, 2012TE:RLD:Yes
Patent:6,479,065Patent Expiration:Aug 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,495,164Patent Expiration:May 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,667,061Patent Expiration:May 25, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022200

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 20125,424,286► subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 20145,424,286► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc