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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Boehringer Ingelheim
Baxter
Deloitte
QuintilesIMS
Fuji
Dow
UBS

Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208984

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NDA 208984 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. 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. Additional details are available on the maraviroc profile page.
Summary for 208984
Tradename:SELZENTRY
Applicant:Viiv Hlthcare
Ingredient:maraviroc
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208984
Generic Entry Date for 208984*:
Constraining patent/regulatory exclusivity:
Dosage::
SOLUTION;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: 208984
Suppliers and Packaging for NDA: 208984
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SELZENTRY maraviroc SOLUTION;ORAL 208984 NDA ViiV Healthcare Company 49702-237 N 49702-237-55

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Nov 4, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 4, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Dec 1, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
Patent:➤ Try a Free TrialPatent 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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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
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Merck
Federal Trade Commission
Fish and Richardson
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Mallinckrodt
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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.