SENSIPAR Drug Patent Profile
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When do Sensipar patents expire, and what generic alternatives are available?
Sensipar is a drug marketed by Amgen and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-one patent family members in twenty-nine countries.
The generic ingredient in SENSIPAR 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 Sensipar
A generic version of SENSIPAR was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on March 8th, 2018.
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Summary for SENSIPAR
| International Patents: | 81 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 17 |
| Patent Applications: | 153 |
| Drug Prices: | Drug price information for SENSIPAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SENSIPAR |
| What excipients (inactive ingredients) are in SENSIPAR? | SENSIPAR excipients list |
| DailyMed Link: | SENSIPAR at DailyMed |
Recent Clinical Trials for SENSIPAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | Phase 4 |
| University of California, San Francisco | Phase 4 |
| Peter Vestergaard | Phase 3 |
Pharmacology for SENSIPAR
| Drug Class | Calcium-sensing Receptor Agonist |
| Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Paragraph IV (Patent) Challenges for SENSIPAR
| 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 SENSIPAR
SENSIPAR is protected by two US patents.
Patents protecting SENSIPAR
Rapid dissolution formulation of a calcium receptor-active compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
Rapid dissolution formulation of a calcium receptor-active compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 SENSIPAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SENSIPAR
See the table below for patents covering SENSIPAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 1203761 | ⤷ Sign Up | |
| Iceland | 3027 | ⤷ Sign Up | |
| Mexico | PA06002616 | FORMULACION DE DISOLUCION RAPIDA DE COMPUESTO ACTIVO DE RECEPTOR DE CALCIO. (RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-ACTIVE COMPOUND.) | ⤷ Sign Up |
| Japan | 5849015 | ⤷ Sign Up | |
| Turkey | 201909267 | ⤷ Sign Up | |
| Australia | 673500 | ⤷ Sign Up | |
| Spain | 2734057 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SENSIPAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1203761 | 05C0029 | France | ⤷ Sign Up | PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022 |
| 1203761 | 300199 | Netherlands | ⤷ Sign Up | |
| 1203761 | SPC/GB05/031 | United Kingdom | ⤷ Sign Up | 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 | SPC020/2005 | Ireland | ⤷ Sign Up | SPC020/2005: 20060407, EXPIRES: 20191021 |
| 1203761 | CA 2005 00027 | Denmark | ⤷ Sign Up | |
| 1203761 | C01203761/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004 |
| 1203761 | 91182 | Luxembourg | ⤷ Sign Up | 91182, EXPIRES: 20191022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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