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TIGECYCLINE

NDA

TIGECYCLINE | N208744 | ACCORD HEALTHCARE INC USA

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
Pfizer Inc. et al v. Accord Healthcare, Inc. 1:2016cv00079 3 patentstigecycline	D. Del.	2016-02-11	Terminated 2017-02-15	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Tigecycline (2023)

Total Spending

$49K

Total Claims

1,209

Beneficiaries

ASP Price

—

HCPCS: J3243 — Injection, tigecycline, 1 mg

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

API Supply Chain12 active DMFs

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

UNIMARK REMEDIES LTDTIGECYCLINE TECHNICAL

DMF 222472008

TAPI NL BVTIGECYCLINE

DMF 227672009

OLON SPATIGECYCLINE HYDROCHLORIDE

DMF 228412009

GLAND PHARMA LTDTIGECYCLINE USP

DMF 259352012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDTIGECYCLINE USP

DMF 263112012

MELODY HEALTHCARE PVT LTDTIGECYCLINE USP

DMF 265512012

FUAN PHARMACEUTICAL GROUP CO LTDTIGECYCLINE

DMF 274772013

WUHAN ZY PHARMACEUTICAL CO LTDTIGECYCLINE

DMF 276962013

GLAND PHARMA LTDTIGECYCLINE [MANUFACTURING SITE - II]

DMF 297882015

MAITHRI DRUGS PRIVATE LTDTIGECYCLINE USP (FORM-II) [ROUTE CODE 'TY']

DMF 304222016

GLAND PHARMA LTDTIGECYCLINE [PROCESS – II]

DMF 342962019

WUHAN ZY PHARMACEUTICAL CO LTDTIGECYCLINE (PROCESS II)

DMF 372312022

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 8, 2025	SUPPL -6	View Letter (PDF)
Oct 23, 2020	SUPPL -3	View Letter (PDF)
Jan 26, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jan 18, 2018

No patent or exclusivity listings for this strength.