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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 one NDA. It is available from four 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. Four suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the maraviroc profile page.

Summary for NDA: 022128

Tradename:
SELZENTRY
Applicant:
Viiv Hlthcare
Ingredient:
maraviroc
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

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 Pfizer Laboratories Div Pfizer Inc 0069-0807 0069-0807-60 60 TABLET, FILM COATED in 1 BOTTLE (0069-0807-60)
SELZENTRY
maraviroc
TABLET;ORAL 022128 NDA Pfizer Laboratories Div Pfizer Inc 0069-0808 0069-0808-60 60 TABLET, FILM COATED in 1 BOTTLE (0069-0808-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Aug 6, 2007TE:RLD:No
Patent:7,576,097Patent Expiration:May 25, 2021Product Flag?Substance Flag?YDelist Request?
Patent:6,586,430Patent Expiration:Dec 1, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
Patent:6,667,314Patent Expiration:Aug 6, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1


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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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