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DAPTOMYCIN

NDA

DAPTOMYCIN | N208385 | SAGENT PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Cubist Pharmaceuticals LLC v. Sagent Pharmaceuticals, Inc. 1:2015cv01164 4 patentsANDA 207104daptomycin	D. Del.	2015-12-17	Terminated 2016-03-02	—

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

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. (on behalf of Xellia Pha... FDA-2017-P-6777 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of Xellia Pharmaceutical ApS and Xellia Pharmaceuticals USA, LLC requesting that the FDA assign a therapeutic equivalence evaluation code of BX to Xellia's Daptomycin for Injection, 350 mg/vial, approved under NDA 209949 on October 20, 201	Other	2017-12-14	Withdrawn	Xellia Pharmaceutical
Citizen Petition from Florek & Endres PLLC FDA-2016-P-1319 · 6 docket documents Florek & Endres PLLC filed this suitability petition on behalf of an unnamed client under Section 505(j)(2)(C) requesting that the FDA declare a new strength of Daptomycin powder for intravenous injection of 350 mg/vial suitable for submission of an Abbreviated New Drug Application, with the referen	Other	2016-05-25	Denied	Florek & Endres PLLC
Cubist Pharmaceuticals, Inc. - Citizen Petition FDA-2010-P-0624 · 8 docket documents Cubist Pharmaceuticals, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act on December 3, 2010, requesting that the FDA refrain from approving any abbreviated new drug application for daptomycin (Cubicin, NDA 21-752) as a generic until applicants demons	505(q) Stay Request	2010-12-20	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

78 trials from ClinicalTrials.gov, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin NCT02097953	Early Phase 1	Completed	University of Utah	12	2014-05 → 2016-07
Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics NCT01019395	Phase 1	Completed	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	23	2010-01-05 → 2012-03-20
The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin NCT01626560	Phase 4	Completed	Hospital Universitario Evangelico de Curitiba	20	2012-07 → 2015-03
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections NCT02052388	Phase 2	Completed	Cellceutix Corporation	215	2014-02 → 2014-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$13.42

per ea

Lowest NADAC/Unit

$13.42

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
25021017915DAPTOMYCIN 350 MG VIAL	$13.42	EA	Generic	—	2025-07-23
25021017966DAPTOMYCIN 350 MG VIAL	$13.42	EA	Generic	—	2025-07-23

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$9.07

Highest Price

$14.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
25021-0179-15DAPTOMYCIN 350MG/VIL INJ	$9.07	FSS	Sagent Pharmaceuticals	04/30/2029
25021-0179-16DAPTOMYCIN 350MG/VIL INJ	$14.47	FSS	Sagent Pharmaceuticals	04/30/2029

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

6 letters from Drugs@FDA

Date	Submission	Document
May 5, 2025	SUPPL -11	View Letter (PDF)
Feb 8, 2022	SUPPL -7	View Letter (PDF)
Feb 8, 2022	SUPPL -8	View Letter (PDF)
Apr 6, 2020	SUPPL -5	View Letter (PDF)
Sep 13, 2018	SUPPL -1	View Letter (PDF)
Sep 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 350MG/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 12, 2017

No patent or exclusivity listings for this strength.