Viewing data from:

DAPTOMYCIN

NDA

DAPTOMYCIN | N217415 | HIKMA PHARMACEUTICALS USA INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

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Today

11759497

Aug. 28, 2038

12053502

Aug. 28, 2038

12629337

Jan. 9, 2043

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

79 trials from ClinicalTrials.gov — 1 recruiting, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia NCT06637332	Phase 4	Recruiting	Todd C. Lee MD MPH FIDSA	300	2024-11-14 → 2027-11
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA NCT01419184	Phase 4	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	250	2011-09-09 → 2012-10-05
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)NCT01922011	Phase 3	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	149	2013-09-13 → 2016-12-20
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)NCT03643952	Phase 2	Completed	Merck Sharp & Dohme LLC	18	2018-12-06 → 2020-04-07
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci NCT00428844	Phase 2	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	75	2007-06-26 → 2010-06-23
Catheter Related - Gram Positive Bloodstream Infections NCT00467272	Phase 2	Completed	M.D. Anderson Cancer Center	30	2007-03 → 2012-09
Study to Evaluate Daptomycin Given During Dialysis and After Dialysis NCT00882557	Phase 1	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	16	2009-04-29 → 2009-07-17
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery NCT00701636	Phase 3	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	30	2008-07 → 2010-10
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants NCT00942149	Phase 1	Completed	Duke University	20	2010-01 → 2011-12
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease NCT01012089	N/A	Completed	University of Oklahoma	6	2009-11 → 2014-04

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$10.39

Highest Price

$15.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70594-0060-01DAPTOMYCIN (DAPTOMYCIN 500MG/VIL INJ)	$10.39	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0060-01DAPTOMYCIN (DAPTOMYCIN 500MG/VIL INJ)	$15.82	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0066-01DAPTOMYCIN (DAPTOMYCIN 350MG/VIL INJ)	$14.77	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026
70594-0066-01DAPTOMYCIN (DAPTOMYCIN 350MG/VIL INJ)	$14.92	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain13 active DMFs2 inactive

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

OLON SPADAPTOMYCIN

DMF 229232009

XELLIA PHARMACEUTICALS APSDAPTOMYCIN

DMF 266042012

ZHEJIANG MEDICINE CO LTDDAPTOMYCIN

DMF 267782013

XELLIA PHARMACEUTICALS APSDAPTOMYCIN NON-STERILE

DMF 271792013

CHONGQING DAXIN PHARMACEUTICAL CO LTDDAPTOMYCIN, NON-STERILE, BULK DRUG

DMF 297602015

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 298592015

CHENGDU YACHT BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 305922016

CHENGDU YACHT BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 330042018

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 336712019

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDDAPTOMYCIN (PROCESS II)

DMF 347212020

CKD BIO CORPDAPTOMYCIN

DMF 347572020

CHONGQING DAXIN PHARMACEUTICAL CO LTDDAPTOMYCIN

DMF 352412020

FUJIAN COMHONY BIOTECHNOLOGY CO LTDDAPTOMYCIN

DMF 429892025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDAPTOMYCIN

DMF 247232011

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDInactiveDAPTOMYCIN

DMF 291372015

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 30, 2025	SUPPL -4	View Letter (PDF)
Feb 6, 2025	SUPPL -3	View Letter (PDF)
Jan 31, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 350MG/VIAL

RLD

3 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jan 30, 2023

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11759497	Aug 28, 2038	—	—	Yes	—	—
12053502	Aug 28, 2038	—	—	—		—
12629337	Jan 9, 2043	—	—	Yes	—	—

#002 — 500MG/VIAL

RLD

3 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jan 30, 2023