Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Baxter
Julphar
Covington
Cantor Fitzgerald
McKinsey
Boehringer Ingelheim
Harvard Business School
Citi

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202429

« Back to Dashboard

NDA 202429 describes ZELBORAF, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZELBORAF profile page.

The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
Summary for 202429
Tradename:ZELBORAF
Applicant:Hoffmann La Roche
Ingredient:vemurafenib
Patents:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202429
Generic Entry Date for 202429*:
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: 202429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-02 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
Approval Date:Aug 17, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 6, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Regulatory Exclusivity Expiration:Nov 6, 2024
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Regulatory Exclusivity Expiration:Aug 17, 2018
Regulatory Exclusivity Use:TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA WITH THE BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Argus Health
Express Scripts
AstraZeneca
Cantor Fitzgerald
Boehringer Ingelheim
Cipla
Harvard Business School
US Army

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.