Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
UBS
Citi
US Department of Justice
Express Scripts
Daiichi Sankyo
Covington
Argus Health
QuintilesIMS
Boehringer Ingelheim

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207103

« Back to Dashboard
NDA 207103 describes IBRANCE, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the IBRANCE profile page.

The generic ingredient in IBRANCE is palbociclib. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.

Summary for NDA: 207103

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3

Pharmacology for NDA: 207103

Suppliers and Packaging for NDA: 207103

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBRANCE
palbociclib
CAPSULE;ORAL 207103 NDA Pfizer Laboratories Div Pfizer Inc 0069-0187 0069-0187-21 21 CAPSULE in 1 BOTTLE (0069-0187-21)
IBRANCE
palbociclib
CAPSULE;ORAL 207103 NDA Pfizer Laboratories Div Pfizer Inc 0069-0188 0069-0188-21 21 CAPSULE in 1 BOTTLE (0069-0188-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Feb 3, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 3, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 19, 2019
Regulatory Exclusivity Use:TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
Patent:► SubscribePatent Expiration:Jan 22, 2023Product Flag?YSubstance Flag?YDelist Request?


Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

UBS
US Army
Fuji
Mallinckrodt
Julphar
Covington
Fish and Richardson
Harvard Business School
Colorcon
Merck

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot