Serving leading biopharmaceutical companies globally:
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Serving leading biopharmaceutical companies globally:
Generated: October 23, 2017
| Tradename: | 2 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 20 |
| Formulation / Manufacturing: | see details |
| Ingredient-type | Glucagon-Like Peptide 1 |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
| 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 | 0310-6520 | 0310-6520-04 | 4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE |
BYDUREON PEN |
exenatide synthetic |
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6520 | 0310-6520-04 | 4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE |
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 2MG/VIAL | ||||
| Approval Date: | Jan 27, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 24, 2018 | ||||||||
| Regulatory Exclusivity Use: | INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE | ||||||||
| Patent: | ► Subscribe | Patent Expiration: | Dec 1, 2016 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE | ||||||||
| Patent: | ► Subscribe | Patent Expiration: | Aug 10, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||||||||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ► Subscribe | ► Subscribe | ||||||||
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Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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