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: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022128

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NDA 022128 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SELZENTRY profile page.

The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 022128
Tradename:SELZENTRY
Applicant:Viiv Hlthcare
Ingredient:maraviroc
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022128
Generic Entry Date for 022128*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Pharmacology for NDA: 022128
Suppliers and Packaging for NDA: 022128
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELZENTRY maraviroc TABLET;ORAL 022128 NDA ViiV Healthcare Company 49702-223 49702-223-18 60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18)
SELZENTRY maraviroc TABLET;ORAL 022128 NDA ViiV Healthcare Company 49702-224 49702-224-18 60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18)
Paragraph IV (Patent) Challenges for 022128
Tradename Dosage Ingredient NDA Submissiondate
SELZENTRY TABLET;ORAL maraviroc 022128 2011-08-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 6, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 4, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Nov 4, 2019
Regulatory Exclusivity Use:NEW STRENGTH
Patent:  Start TrialPatent Expiration:Dec 1, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1

Expired US Patents for NDA 022128

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-003 Nov 4, 2016   Start Trial   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-001 Aug 6, 2007   Start Trial   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-004 Nov 4, 2016   Start Trial   Start Trial
Viiv Hlthcare SELZENTRY maraviroc TABLET;ORAL 022128-002 Aug 6, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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