Viewing data from:

PARSABIV

NDA

ETELCALCETIDE | N208325 | KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC

3 strengths8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Jul. 29, 2030

Feb. 7, 2031

Jul. 29, 2030

Jul. 29, 2030

Jun. 27, 2034

Jun. 27, 2034

Jun. 27, 2034

Jun. 27, 2034

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Amgen Inc. v. Aurobindo Pharma Limited et al 1:2022cv00037 1 patentANDA 215840, 215877etelcalcetide	D. Del.	2022-01-10	Terminated 2023-11-08	—
Amgen Inc. et al v. MSN Laboratories Private Limited et al 1:2021cv00712 6 patentsANDA 215877etelcalcetide	D. Del.	2021-05-19	Terminated 2023-11-08	—
Amgen Inc. et al v. MSN Laboratories Private Limited, et al. 1:2021cv00662 2 patentsANDA 215840etelcalcetide	D. Del.	2021-05-06	Terminated 2023-11-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDETELCALCETIDE HYDROCHLORIDE

DMF 350972020

AURO PEPTIDES LTDETELCALCETIDE HYDROCHLORIDE

DMF 353862020

USV PRIVATE LTDETELCALCETIDE HYDROCHLORIDE

DMF 357682021

ZHEJIANG PEPTITES BIOTECH CO LTDETELCALCETIDE HYDROCHLORIDE

DMF 433122025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2021	SUPPL -5	View Letter (PDF)
Mar 12, 2019	SUPPL -2	View Letter (PDF)
Aug 27, 2018	SUPPL -1	View Letter (PDF)
Feb 8, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG/0.5ML (2.5MG/0.5ML)

RLD

8 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 7, 2017

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8377880	Jul 29, 2030	—	Yes	Yes	—	—
8999932	Feb 7, 2031	—	Yes	Yes		—
9278995	Jul 29, 2030	—	Yes	—	—	—
9701712	Jul 29, 2030	—	Yes	Yes		—
9820938	Jun 27, 2034	—	—	Yes	—	—
10344765	Jun 27, 2034	—	—	Yes	—	—
11162500	Jun 27, 2034	—	—	Yes	—	—
11959486	Jun 27, 2034	—	—	Yes		—

#002 — 5MG/ML (5MG/ML)

RLD

8 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 7, 2017

#003 — 10MG/2ML (5MG/ML)

RLD

8 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 7, 2017