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CUBICIN

NDA

DAPTOMYCIN | N021572 | CUBIST PHARMACEUTICALS LLC

3 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayIPRPTAB Challenge

2027

2028

2029

2030

2031

Today

8003673

Sep. 4, 2028

9138456

Nov. 23, 2030IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2020-00193	9138456	IPR	Amneal Pharmaceuticals LLC et al.	Institution Denied	2019-11-27	—

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. CIPLA USA INC. et al 3:2019cv12920 1 patentANDA 213027daptomycin	D.N.J.	2019-05-24	Terminated 2020-10-21	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria NCT07058415	N/A	Not Yet Recruiting	Centre Hospitalier Universitaire de Nice	75	2026-07 → 2027-05

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

Medicare Part B Spending

CMS physician-administered drug spending for Cubicin (2023)

Total Spending

$2.3M

Total Claims

66,415

Beneficiaries

4,019

ASP Price

—

HCPCS: J0878 — Injection, daptomycin, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain12 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

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

39 letters from Drugs@FDA

Date	Submission	Document
May 15, 2025	SUPPL -69	View Letter (PDF)
May 14, 2025	SUPPL -70	View Letter (PDF)
Feb 24, 2022	SUPPL -68	View Letter (PDF)
Oct 27, 2021	SUPPL -66	View Letter (PDF)
Oct 27, 2021	SUPPL -65	View Letter (PDF)
Aug 27, 2020	SUPPL -63	View Letter (PDF)
Aug 27, 2020	SUPPL -64	View Letter (PDF)
Dec 7, 2018	SUPPL -61	View Letter (PDF)
Sep 6, 2017	SUPPL -57	View Letter (PDF)
Sep 6, 2017	SUPPL -60	View Letter (PDF)
Jun 12, 2017	SUPPL -59	View Letter (PDF)
Apr 3, 2017	SUPPL -58	View Letter (PDF)
Apr 3, 2017	SUPPL -55	View Letter (PDF)
Jul 12, 2016	SUPPL -53	View Letter (PDF)
Sep 18, 2015	SUPPL -50	View Letter (PDF)
Aug 6, 2015	SUPPL -48	View Letter (PDF)
Nov 28, 2014	SUPPL -46	View Letter (PDF)
Nov 26, 2013	SUPPL -44	View Letter (PDF)
Nov 26, 2013	SUPPL -43	View Letter (PDF)
Oct 15, 2012	SUPPL -40	View Letter (PDF)
Jun 15, 2012	SUPPL -39	View Letter (PDF)
May 23, 2012	SUPPL -37	View Letter (PDF)
Oct 4, 2011	SUPPL -38	View Letter (PDF)
Dec 10, 2010	SUPPL -31	View Letter (PDF)
Dec 6, 2010	SUPPL -30	View Letter (PDF)
Dec 6, 2010	SUPPL -23	View Letter (PDF)
Dec 6, 2010	SUPPL -22	View Letter (PDF)
Dec 6, 2010	SUPPL -24	View Letter (PDF)
Dec 6, 2010	SUPPL -27	View Letter (PDF)
Dec 6, 2010	SUPPL -32	View Letter (PDF)
Feb 13, 2009	SUPPL -21	View Letter (PDF)
Oct 10, 2007	SUPPL -14	View Letter (PDF)
Aug 22, 2007	SUPPL -7	View Letter (PDF)
Feb 23, 2007	SUPPL -11	View Letter (PDF)
Feb 23, 2007	SUPPL -10	View Letter (PDF)
Nov 6, 2006	SUPPL -9	View Letter (PDF)
May 26, 2006	SUPPL -8	View Letter (PDF)
Oct 19, 2005	SUPPL -6	View Letter (PDF)
Sep 25, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 12, 2003

No patent or exclusivity listings for this strength.

#002 — 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Sep 12, 2003

#003 — 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jul 6, 2016