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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Fish and Richardson
Boehringer Ingelheim
Queensland Health

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021688

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NDA 021688 describes SENSIPAR, which is a drug marketed by Amgen and is included in one NDA. It is available from six suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SENSIPAR profile page.

The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

Summary for NDA: 021688

Therapeutic Class:Hormonal Agents, Suppressant (Parathyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021688

Suppliers and Packaging for NDA: 021688

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cinacalcet hydrochloride
TABLET;ORAL 021688 NDA State of Florida DOH Central Pharmacy 53808-0577 53808-0577-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0577-1)
cinacalcet hydrochloride
TABLET;ORAL 021688 NDA State of Florida DOH Central Pharmacy 53808-0578 53808-0578-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0578-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 8, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:May 23, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Feb 25, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Nov 21, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 021688

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Serving 500+ biopharmaceutical companies globally:

US Army
Johnson and Johnson
Daiichi Sankyo
Federal Trade Commission
Argus Health

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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