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Serving leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Johnson and Johnson
Chubb
Federal Trade Commission
Queensland Health
Novartis
Teva
Harvard Business School
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207103

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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 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?


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Serving leading biopharmaceutical companies globally:

Covington
Fuji
Cerilliant
Accenture
Cantor Fitzgerald
Boehringer Ingelheim
Dow
Cipla
Farmers Insurance
Mallinckrodt

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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