Viewing data from:

SIVEXTRO

NDA

TEDIZOLID PHOSPHATE | N205435 | CUBIST PHARMACEUTICALS LLC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

Today

Jun. 20, 2028

Feb. 23, 2028

Dec. 31, 2030

Feb. 3, 2030

Feb. 3, 2030

Feb. 3, 2030

Feb. 3, 2030

NPP

Apr. 4, 2028

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

21 trials from ClinicalTrials.gov — 1 recruiting, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis NCT05398679	Phase 4	Recruiting	Fundacion Clinic per a la Recerca Biomédica	360	2022-08-17 → 2027-12-30
Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)NCT03009045	Phase 2	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	44	2017-02-06 → 2021-08-06
Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults NCT02342418	Phase 4	Completed	Amit.Pai	19	2015-03 → 2015-12
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)NCT03176134	Phase 3	Completed	Merck Sharp & Dohme LLC	100	2019-01-20 → 2023-07-06
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response NCT01577459	Phase 1	Completed	Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	18	2012-04-23 → 2012-06-15
A Study to Evaluate the Effects of Tedizolid Phosphate on the Pharmacokinetics and Safety of Midazolam and Rosuvastatin (MK-1986-004)NCT02477514	Phase 1	Completed	Merck Sharp & Dohme LLC	18	2015-06 → 2015-08
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study NCT01519778	Phase 2	Completed	Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	200	2012-02-15 → 2012-08-27
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment NCT01452828	Phase 1	Completed	Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	24	2011-10 → 2012-03
Tedizolid Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis NCT02620787	Phase 1	Completed	Hartford Hospital	18	2016-02-23 → 2017-03-01
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.NCT01170221	Phase 3	Completed	Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	667	2010-08-15 → 2011-09-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$472.95

per ea

Lowest NADAC/Unit

$472.95

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
67919004104SIVEXTRO 200 MG TABLET	$472.95	EA	Brand	—	2026-08-19
67919004105SIVEXTRO 200 MG TABLET	$472.95	EA	Brand	—	2026-08-19

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

VA Federal Supply Schedule

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

Lowest Price

$1920.20

Highest Price

$13742.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67919-0041-04SIVEXTRO 200MG TAB	$9576.40	Big4	Merck Sharp & Dohme LLC	05/31/2030
67919-0041-04SIVEXTRO 200MG TAB	$13742.01	FSS	Merck Sharp & Dohme LLC	05/31/2030
67919-0041-05SIVEXTRO 200MG TAB,UD	$1920.20	Big4	Merck Sharp & Dohme LLC	05/31/2030
67919-0041-05SIVEXTRO 200MG TAB,UD	$2748.36	FSS	Merck Sharp & Dohme LLC	05/31/2030

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

Medicare Part D Spending

CMS annual spending data for Sivextro (2024)

Total Spending

$16.5M

Total Claims

1,534

Beneficiaries

505

Avg Cost/Unit

$421.26

Spending Trend

$11.9M(2019)→$12.7M(2020)→$12.8M(2021)→$17.8M(2022)→$11.5M(2023)→$16.5M(2024)

YoY Change:-4.6%

5yr CAGR:+1.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Sivextro (2024)

Total Spending

$52K

Total Claims

149

Beneficiaries

ASP Price

$1.80

Spending Trend

$244K(2019)→$80K(2020)→$44K(2021)→$72K(2022)→$53K(2023)→$52K(2024)

YoY Change:+6.5%

5yr CAGR:+3.5%

HCPCS: J3090 — Injection, tedizolid phosphate, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain7 active DMFs

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

METROCHEM API PRIVATE LTDTEDIZOLID PHOSPHATE

DMF 355152021

ANHUI BIOCOMPOUNDS PHARMACEUTICAL CO LTDTEDIZOLID PHOSPHATE

DMF 393812024

NANJING YOKO PHARMACEUTICAL CO LTDTEDIZOLID PHOSPHATE NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 404902024

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDTEDIZOLID PHOSPHATE

DMF 404982024

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDTEDIZOLID PHOSPHATE NON-STERILE DRUG SUBSTANCE

DMF 407742024

ALP PHARM BEIJING CO LTDTEDIZOLID PHOSPHATE

DMF 418502025

ARENE LIFE SCIENCES PRIVATE LTDTEDIZOLID PHOSPHATE

DMF 426482025

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2026	SUPPL -19	View Letter (PDF)
Apr 8, 2025	SUPPL -16	View Letter (PDF)
Nov 18, 2021	SUPPL -14	View Letter (PDF)
Oct 27, 2020	SUPPL -13	View Letter (PDF)
Jun 22, 2020	SUPPL -12	View Letter (PDF)
Sep 11, 2019	SUPPL -11	View Letter (PDF)
Mar 8, 2019	SUPPL -10	View Letter (PDF)
Aug 21, 2017	SUPPL -8	View Letter (PDF)
Aug 21, 2017	SUPPL -7	View Letter (PDF)
Oct 31, 2016	SUPPL -3	View Letter (PDF)
Sep 19, 2016	SUPPL -6	View Letter (PDF)
Jun 7, 2016	SUPPL -5	View Letter (PDF)
Mar 6, 2015	SUPPL -1	View Letter (PDF)
Jun 23, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLD

7 patents1 exclusivity▴

TABLET;ORAL | Approved: Jun 20, 2014

Patents (7) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7816379	Jun 20, 2028	—	Yes	Yes		—
8420676	Feb 23, 2028	—	Yes	Yes		—
8426389	Dec 31, 2030	—	Yes	Yes		—
9624250	Feb 3, 2030	—	Yes	Yes		—
9988406	Feb 3, 2030	—	—	Yes	—	—
10065947	Feb 3, 2030	—	—	Yes	—	—
10442829	Feb 3, 2030	—	Yes	—	—	—

Exclusivities (1)

Code	Date	Status
NPP	Apr 4, 2028	Active