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Details for New Drug Application (NDA): 021773

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NDA 021773 describes BYETTA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. 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. Three suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for NDA: 021773

Tradename:
BYETTA
Applicant:
Astrazeneca Ab
Ingredient:
exenatide synthetic
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 021773

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300MCG/1.2ML (250MCG/ML)
Approval Date:Apr 28, 2005TE:RLD:Yes
Patent:6,902,744Patent Expiration:Jan 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,297,761Patent Expiration:Oct 15, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:7,521,423Patent Expiration:Oct 15, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021773

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 20055,424,286► subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 20055,424,286► subscribe
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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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