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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Sivextro* (2023)

Total Spending

$11.5M

Total Claims

1,232

Beneficiaries

489

Avg Cost/Unit

$441.52

Spending Trend

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

YoY Change:+1.8%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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)

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