You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 19, 2024

Cinacalcet hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic drug sources for cinacalcet hydrochloride and what is the scope of freedom to operate?

Cinacalcet hydrochloride is the generic ingredient in two branded drugs 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, Watson Labs Teva, and Amgen, and is included in fifteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cinacalcet hydrochloride has eighty-one patent family members in twenty-nine countries.

There are twenty-two drug master file entries for cinacalcet hydrochloride. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for cinacalcet hydrochloride

International Patents:	81
US Patents:	2
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	62
Patent Applications:	314
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cinacalcet hydrochloride
What excipients (inactive ingredients) are in cinacalcet hydrochloride?	cinacalcet hydrochloride excipients list
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

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	90MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	60MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	30MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	213325-002	May 18, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	207008-002	Oct 11, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Slate Run Pharma	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210207-003	Aug 1, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210548-002	Jun 28, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cinacalcet hydrochloride

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	⤷ Try a Trial	⤷ Try a Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	⤷ Try a Trial	⤷ Try a Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	⤷ Try a Trial	⤷ Try a Trial
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for cinacalcet hydrochloride

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
China	1946382	Rapid dissolution formulation of a calcium receptor-active compound	⤷ Try a Trial
Hungary	E045411		⤷ Try a Trial
Japan	2007505108		⤷ Try a Trial
Eurasian Patent Organization	013425	БЫСТРОРАСТВОРИМАЯ ЛЕКАРСТВЕННАЯ ФОРМА СОЕДИНЕНИЯ, ДЕЙСТВУЮЩЕГО НА КАЛЬЦИЕВЫЙ РЕЦЕПТОР (RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-ACTIVE COMPOUND)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cinacalcet hydrochloride

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	SPC/GB05/031	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410
1203761	C01203761/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761	05C0029	France	⤷ Try a Trial	PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.