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TIGECYCLINE

NDA

TIGECYCLINE | N211158 | AMNEAL PHARMACEUTICALS LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

Today

9855335

Apr. 7, 2033

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Freyr Inc. FDA-2018-P-4340 · 5 docket documents Freyr Inc. submitted this petition pursuant to section 505(j)(2)(C) of the FD&C Act requesting that the FDA determine Tigecycline for Injection, 50 mg/vial containing 82.6 mg of arginine as a stabilizing agent is suitable for submission as an ANDA, noting that this same composition was already appro	Other	2018-11-14	Open	Freyr Inc.

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

Clinical Trials

43 trials from ClinicalTrials.gov — 2 recruiting, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment NCT04310930	Phase 2/3	Recruiting	The University of Queensland	300	2020-03-02 → 2030-06-30
Personalized Treatment of Urogenital Cancers Depends on the Microbiome NCT03962920	N/A	Recruiting	Zealand University Hospital	28	2020-05-01 → 2027-05-01
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)NCT00230971	Phase 4	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	473	2005-10 → 2008-09
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia NCT00080496	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	430	2003-07 → 2006-12
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis NCT00406237	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	8	2006-12 → 2009-03
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection NCT01721408	Phase 4	Completed	Pfizer	470	2012-11 → 2015-10
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection NCT00419991	Phase 4	Completed	CPL Associates	10	2007-01 → 2008-05
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms NCT00079989	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	115	2003-12 → 2005-11
A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia NCT00614679	Phase 1	Completed	University of California, San Diego	18	2006-10 → 2009-12
Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections NCT00136201	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	200	2005-11 → 2006-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$72.40

Highest Price

$310.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70121-1647-07TIGECYCLINE 50MG/VIL INJ	$310.93	FSS	Amneal Pharmaceuticals of New York, LLC	06/30/2027
70121-1647-07TIGECYCLINE 50MG/VIL INJ	$72.40	Big4	Amneal Pharmaceuticals of New York, LLC	06/30/2027

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

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

4 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -7	View Letter (PDF)
Nov 12, 2020	SUPPL -5	View Letter (PDF)
Aug 3, 2020	SUPPL -3	View Letter (PDF)
Aug 3, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

1 patent0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Aug 2, 2018

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9855335	Apr 7, 2033	—	—	Yes	—	—