CINACALCET HYDROCHLORIDE Drug Patent Profile

When do Cinacalcet Hydrochloride patents expire, and when can generic versions of Cinacalcet Hydrochloride launch?

Cinacalcet Hydrochloride is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Mylan, Slate Run Pharma, Stevens J, Strides Pharma, Sun Pharm, and Watson Labs Teva. and is included in fourteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cinacalcet Hydrochloride

A generic version of CINACALCET HYDROCHLORIDE was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on March 8^th, 2018.

Summary for CINACALCET HYDROCHLORIDE

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	62
Patent Applications:	163
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CINACALCET HYDROCHLORIDE
DailyMed Link:	CINACALCET HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CINACALCET HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Hengrui Pharmaceutical Co., Ltd.	Phase 2
University of California, San Francisco	Phase 4
VA Office of Research and Development	Phase 4

See all CINACALCET HYDROCHLORIDE clinical trials

Pharmacology for CINACALCET HYDROCHLORIDE

Drug Class	Calcium-sensing Receptor Agonist
Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

Medical Subject Heading (MeSH) Categories for CINACALCET HYDROCHLORIDE

Calcimimetic Agents

Anatomical Therapeutic Chemical (ATC) Classes for CINACALCET HYDROCHLORIDE

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for CINACALCET HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SENSIPAR	Tablets	cinacalcet hydrochloride	30 mg, 60 mg and 90 mg	021688	1	2008-03-10

US Patents and Regulatory Information for CINACALCET HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Teva	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	204377-002	Dec 27, 2018	AB	RX	No	No
Stevens J	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	204364-002	Dec 2, 2021		DISCN	No	No
Slate Run Pharma	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210207-001	Aug 1, 2018	AB	RX	No	No
Stevens J	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	204364-003	Dec 2, 2021		DISCN	No	No
Slate Run Pharma	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210207-002	Aug 1, 2018	AB	RX	No	No
Accord Hlthcare	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	211892-001	May 15, 2020	AB	RX	No	No