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Etelcalcetide - Generic Drug Details
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What are the generic drug sources for etelcalcetide and what is the scope of freedom to operate?
Etelcalcetide
is the generic ingredient in one branded drug marketed by Kai Pharms Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Etelcalcetide has ninety-one patent family members in forty-one countries.
One supplier is listed for this compound.
Summary for etelcalcetide
International Patents: | 91 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 13 |
Clinical Trials: | 8 |
Patent Applications: | 26 |
Drug Prices: | Drug price trends for etelcalcetide |
DailyMed Link: | etelcalcetide at DailyMed |
Recent Clinical Trials for etelcalcetide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amgen | Phase 2 |
Prim. Priv. Doz. Dr. Daniel Cejka | Phase 2 |
Thomas Nickolas, MD MS | Phase 2 |
Pharmacology for etelcalcetide
Drug Class | Calcium-sensing Receptor Agonist |
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
US Patents and Regulatory Information for etelcalcetide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-003 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-001 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-001 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-002 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for etelcalcetide
Country | Patent Number | Estimated Expiration |
---|---|---|
Croatia | P20171092 | Start Trial |
Japan | 5270799 | Start Trial |
Japan | 2013155195 | Start Trial |
Canada | 2916222 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for etelcalcetide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2459208 | CA 2017 00006 | Denmark | Start Trial | PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115 |
2459208 | 122017000021 | Germany | Start Trial | PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 20161111 |
2459208 | 17C1009 | France | Start Trial | PRODUCT NAME: ETELCALCETIDE, OU UN SEL DE CELUI-CI, NOTAMMENT LE CHLORHYDRATE D'ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115 |
2459208 | 8/2017 | Austria | Start Trial | PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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