Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

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 one supplier. There are five patents protecting this drug. Additional details are available on the EGRIFTA profile page.

The generic ingredient in EGRIFTA is tesamorelin acetate. One supplier is listed for this compound. Additional details are available on the tesamorelin acetate profile page.
Summary for 022505
Tradename:EGRIFTA
Applicant:Theratechnologies
Ingredient:tesamorelin acetate
Patents:5
Generic Entry Opportunity Date for 022505
Generic Entry Date for 022505*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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.

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 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 > 10 mL in 1 BOTTLE
EGRIFTA tesamorelin acetate POWDER;SUBCUTANEOUS 022505 NDA Theratechnologies Inc. 62064-041 62064-041-30 1 KIT in 1 BOX (62064-041-30) * .5 mL in 1 VIAL * 30 BOTTLE in 1 TRAY > 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 1MG BASE/VIAL
Approval Date:Nov 10, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 26, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
Patent:  Start TrialPatent Expiration:Jul 14, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
Patent:  Start TrialPatent Expiration:Aug 14, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY

Expired US Patents for NDA 022505

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Theratechnologies EGRIFTA tesamorelin acetate POWDER;SUBCUTANEOUS 022505-001 Nov 10, 2010   Start Trial   Start Trial
Theratechnologies EGRIFTA tesamorelin acetate POWDER;SUBCUTANEOUS 022505-002 Nov 29, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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