Details for New Drug Application (NDA): 021773
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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
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