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Details for New Drug Application (NDA): 022505

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NDA 022505 describes EGRIFTA, which is a drug marketed by Theratechnologies and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the EGRIFTA profile page.

The generic ingredient in EGRIFTA is tesamorelin acetate. Two suppliers are listed for this compound. Additional details are available on the tesamorelin acetate profile page.

Summary for NDA: 022505

Tradename:
EGRIFTA
Applicant:
Theratechnologies
Ingredient:
tesamorelin acetate
Patents:3

Suppliers and Packaging for NDA: 022505

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EGRIFTA
tesamorelin acetate
POWDER;SUBCUTANEOUS 022505 NDA EMD Serono, Inc. 44087-2011 44087-2011-2 1 KIT in 1 BOX (44087-2011-2) * 2 mL in 1 VIAL * 10 mL in 1 BOTTLE (0409-4887-34)
EGRIFTA
tesamorelin acetate
POWDER;SUBCUTANEOUS 022505 NDA Theratechnologies Inc. 62064-011 62064-011-60 1 KIT in 1 BOX (62064-011-60) * 1 mL in 1 VIAL * 30 BOTTLE in 1 TRAY (0409-4887-34) > 10 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 1MG BASE/VIAL
Approval Date:Nov 10, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 10, 2015
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:5,861,379Patent Expiration:May 26, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
Patent:7,144,577Patent Expiration:Jul 14, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY

Expired Orange Book Patents for NDA: 022505

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Theratechnologies
EGRIFTA
tesamorelin acetate
POWDER;SUBCUTANEOUS022505-001Nov 10, 20106,020,311► subscribe
Theratechnologies
EGRIFTA
tesamorelin acetate
POWDER;SUBCUTANEOUS022505-002Nov 29, 20116,020,311► 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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