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. 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. 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: | 20 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
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: | Jul 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jan 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 4, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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