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Details for New Drug Application (NDA): 022200
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NDA 022200 describes BYDUREON PEN, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-two 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. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.
The generic ingredient in BYDUREON PEN 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 022200
| Tradename: | BYDUREON PEN |
| Applicant: | Astrazeneca Ab |
| Ingredient: | exenatide synthetic |
| Patents: | 22 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022200
Generic Entry Date for 022200*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR 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: 022200
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
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 | 0310-6530 | 0310-6530-01 | 1 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE |
| BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6530 | 0310-6530-01 | 1 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 2MG/VIAL | ||||
| Approval Date: | Jan 27, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 15, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES | ||||||||
| Regulatory Exclusivity Expiration: | Apr 2, 2021 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN | ||||||||
| Regulatory Exclusivity Expiration: | Aug 15, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 022200
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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