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. There are eleven 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. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.
The generic ingredient in BYDUREON BCISE is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are 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: | 11 |
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 2MG/0.85ML (2MG/0.85ML) | ||||
| Approval Date: | Oct 20, 2017 | 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: | ⤷ Get Started Free | Patent Expiration: | Apr 4, 2026 | Product 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astrazeneca Ab | BYDUREON BCISE | exenatide synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210-001 | Oct 20, 2017 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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