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: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050793

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NDA 050793 describes CLINDESSE, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CLINDESSE profile page.

The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050793
Tradename:CLINDESSE
Applicant:Perrigo Pharma Intl
Ingredient:clindamycin phosphate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 050793
Suppliers and Packaging for NDA: 050793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793 NDA Perrigo New York Inc 45802-042 45802-042-01 1 APPLICATOR in 1 CARTON (45802-042-01) > 5 g in 1 APPLICATOR
CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793 NDA Perrigo New York Inc 45802-042 45802-042-02 1 APPLICATOR in 1 CARTON (45802-042-02) > 5 g in 1 APPLICATOR
Paragraph IV (Patent) Challenges for 050793
Tradename Dosage Ingredient NDA Submissiondate
CLINDESSE CREAM;VAGINAL clindamycin phosphate 050793 2015-02-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrengthEQ 2% BASE
Approval Date:Nov 30, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 27, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL VAGINOSIS
Patent:  Start TrialPatent Expiration:Dec 2, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL VAGINOSIS

Expired US Patents for NDA 050793

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start Trial
Perrigo Pharma Intl CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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