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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Etelcalcetide has one hundred and four patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for etelcalcetide
International Patents: | 104 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 19 |
Patent Applications: | 146 |
Drug Prices: | Drug price trends for etelcalcetide |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for etelcalcetide |
What excipients (inactive ingredients) are in etelcalcetide? | etelcalcetide excipients list |
DailyMed Link: | etelcalcetide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for etelcalcetide
Generic Entry Date for etelcalcetide*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Anatomical Therapeutic Chemical (ATC) Classes for etelcalcetide
Paragraph IV (Patent) Challenges for ETELCALCETIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PARSABIV | Injection | etelcalcetide | 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL | 208325 | 2 | 2021-02-08 |
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 | 11,959,486 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-003 | Feb 7, 2017 | RX | Yes | Yes | 11,162,500 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-002 | Feb 7, 2017 | RX | Yes | Yes | 8,999,932 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-002 | Feb 7, 2017 | RX | Yes | Yes | 8,377,880 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Kai Pharms Inc | PARSABIV | etelcalcetide | SOLUTION;INTRAVENOUS | 208325-001 | Feb 7, 2017 | RX | Yes | Yes | 9,820,938 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for etelcalcetide
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Amgen Europe B.V. | Parsabiv | etelcalcetide | EMEA/H/C/003995 Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy. |
Authorised | no | no | no | 2016-11-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for etelcalcetide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Costa Rica | 20160061 | ⤷ Try for Free | |
Hungary | E030960 | ⤷ Try for Free | |
Lithuania | 3013318 | ⤷ Try for Free | |
Spain | 2633989 | ⤷ Try for Free | |
Eurasian Patent Organization | 201690099 | УСТОЙЧИВАЯ ЖИДКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ AMG-416 (ВЕЛКАЛЬЦЕТИД) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for etelcalcetide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2459208 | 132017000041085 | Italy | ⤷ Try for Free | PRODUCT NAME: ETELCALCETIDE, O UN SUO SALE, COMPRESO ETELCALCETIDE IDROCLORURO(PARSABIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1142/001-012, 20161115 |
2459208 | 2017021 | Norway | ⤷ Try for Free | 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 | CR 2017 00006 | Denmark | ⤷ Try for Free | PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115 |
2459208 | LUC00008 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115 |
2459208 | SPC/GB17/018 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: ETELCALCETIDE, OR A SALT THEROF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REGISTERED: UK EU/1/16/1142/001-012 20161115; UK PLGB 13832/0039 20161115; UK PLGB 13832/0040 20161115; UK PLGB 13832/0041 20161115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Etelcalcetide
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