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Etelcalcetide - Generic Drug Details
What are the generic 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 eighty-seven patent family members in forty-one countries.
One supplier is listed for this compound.
Summary for etelcalcetide
| International Patents: | 87 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 7 |
| 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 |
|---|---|
| Prim. Priv. Doz. Dr. Daniel Cejka | Phase 2 |
| Amgen | 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 |
Synonyms for etelcalcetide
| 1262780-97-1 |
| 60ME133FJB |
| AMG 416 |
| AMG-416 |
| CHEBI:134700 |
| CHEMBL3545184 |
| D-Argininamide, N-acetyl-D-cysteinyl-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-, disulfide with L-cysteine |
| D10676 |
| DB12865 |
| DTXSID70155132 |
| Etelcalcetide (USAN/INN) |
| Etelcalcetide [USAN:INN] |
| Etelcalcetide Hydrochloride(AMG-416) |
| J3.559.823E |
| KAI 4169 |
| KAI-4169 |
| Parsabiv |
| UNII-60ME133FJB |
| Velcalcetide |
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 | 208325-002 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-003 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-002 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-003 | Feb 7, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 | ||
| >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 |
|---|---|---|
| South Africa | 201200726 | Start Trial |
| Denmark | 3192520 | Start Trial |
| Costa Rica | 20160002 | Start Trial |
| Singapore | 178143 | Start Trial |
| Hungary | E034209 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for etelcalcetide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2459208 | 1790012-7 | Sweden | Start Trial | PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115 |
| 2459208 | 2017021 | Norway | Start Trial | PRODUCT NAME: ETELKALSETID, ELLER ET SALT DERAV, INKLUDERT ETELKALSETIDHYDROKLORID; NAT. REG. NO/DATE: EU/1/16/1142 20161122; FIRST REG. NO/DATE: EU/1/16/1142/001-012 20161115 |
| 2459208 | PA2017007 | Lithuania | Start Trial | PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111 |
| 2459208 | C20170006 00208 | Estonia | Start Trial | PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016 |
| 2459208 | LUC00008 | Luxembourg | Start Trial | PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115 |
| >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 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.
ISSN: 2162-2639
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Major Patent Expirations 2019 - 2020
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.