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Last Updated: August 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205395


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NDA 205395 describes PREZCOBIX, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the PREZCOBIX profile page.

The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir profile page.
Summary for 205395
Tradename:PREZCOBIX
Applicant:Janssen Prods
Ingredient:cobicistat; darunavir
Patents:4
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205395
Generic Entry Date for 205395*:
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.

Suppliers and Packaging for NDA: 205395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395 NDA Janssen Products LP 59676-575 59676-575-30 30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)
Paragraph IV (Patent) Challenges for 205395
Tradename Dosage Ingredient NDA Submissiondate
PREZCOBIX TABLET;ORAL cobicistat; darunavir 205395 2020-07-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;800MG
Approval Date:Jan 29, 2015TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Oct 6, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Free Forever TrialPatent Expiration:Sep 3, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE

Expired US Patents for NDA 205395

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Medtronic
Merck
McKesson
McKinsey

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 verification 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.