Details for New Drug Application (NDA): 021773
✉ Email this page to a colleague
NDA 021773 describes BYETTA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. Additional details are available on the BYETTA profile page.
The generic ingredient in BYETTA 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 BYETTA 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 021773
| Tradename: | BYETTA |
| Applicant: | Astrazeneca Ab |
| Ingredient: | exenatide synthetic |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021773
Generic Entry Date for 021773*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES Dosage:
INJECTABLE;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: 021773
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 021773
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6512 | 0310-6512-01 | 1 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE |
| BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6524 | 0310-6524-01 | 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 300MCG/1.2ML (250MCG/ML) | ||||
| Approval Date: | Apr 28, 2005 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 4, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 600MCG/2.4ML (250MCG/ML) | ||||
| Approval Date: | Apr 28, 2005 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 4, 2024 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES | ||||||||
Expired US Patents for NDA 021773
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-001 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | BYETTA | exenatide synthetic | INJECTABLE;SUBCUTANEOUS | 021773-002 | Apr 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
