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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
McKinsey
Fuji
Cerilliant
US Department of Justice
Harvard Business School
US Army
Medtronic
Cipla

Generated: January 16, 2018

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 021688
Tradename:SENSIPAR
Applicant:Amgen
Ingredient:cinacalcet hydrochloride
Patents:5
Therapeutic Class:Hormonal Agents, Suppressant (Parathyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021688
Medical Subject Heading (MeSH) Categories for 021688
Suppliers and Packaging for NDA: 021688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSIPAR 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)
SENSIPAR 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)

Profile 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 US Patents for NDA 021688

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Chubb
Queensland Health
McKinsey
Cantor Fitzgerald
Deloitte
Harvard Business School
US Department of Justice
Johnson and Johnson

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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