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TYGACIL

NDA

TIGECYCLINE | N021821 | PF PRISM CV

1 strength6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Expired (3)Active (3)TodayIPRPTAB Challenge

2026

2027

2028

2029

2030

Today

Feb. 5, 2029IPR×3

Oct. 8, 2030

Oct. 24, 2028

Mar. 13, 2026

Mar. 13, 2026

Mar. 13, 2026

PTAB Proceedings

3 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2015-00873	7879828	IPR	Apotex Inc. et al.	Institution Denied	2015-03-12	—
IPR2014-01259	7879828	IPR	Initiative for Responsibility in Drug Pricing LLC	Institution Denied	2014-08-08	—
IPR2014-00115	7879828	IPR	Apotex Inc. et al.	Final Written Decision	2013-11-01	—

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 Tygacil (2023)

Total Spending

$269K

Total Claims

192

Beneficiaries

Avg Cost/Unit

$21.04

Spending Trend

$1.5M(2019)→$713K(2020)→$501K(2021)→$352K(2022)→$269K(2023)

YoY Change:+102.4%

5yr CAGR:+21.5%

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

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

27 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -56	View Letter (PDF)
Jun 24, 2020	SUPPL -49	View Letter (PDF)
Jan 17, 2020	SUPPL -48	View Letter (PDF)
Apr 17, 2018	SUPPL -45	View Letter (PDF)
Jun 30, 2016	SUPPL -42	View Letter (PDF)
Jun 1, 2016	SUPPL -39	View Letter (PDF)
Jan 21, 2016	SUPPL -43	View Letter (PDF)
Oct 1, 2013	SUPPL -31	View Letter (PDF)
Oct 1, 2013	SUPPL -26	View Letter (PDF)
May 28, 2013	SUPPL -37	View Letter (PDF)
Jul 23, 2010	SUPPL -27	View Letter (PDF)
Jul 23, 2010	SUPPL -25	View Letter (PDF)
Jul 23, 2010	SUPPL -21	View Letter (PDF)
Jun 30, 2009	SUPPL -22	View Letter (PDF)
Mar 25, 2009	SUPPL -13	View Letter (PDF)
Mar 25, 2009	SUPPL -18	View Letter (PDF)
Mar 25, 2009	SUPPL -17	View Letter (PDF)
Feb 13, 2009	SUPPL -16	View Letter (PDF)
Feb 3, 2009	SUPPL -11	View Letter (PDF)
Feb 3, 2009	SUPPL -19	View Letter (PDF)
Feb 3, 2009	SUPPL -14	View Letter (PDF)
May 29, 2007	SUPPL -10	View Letter (PDF)
Apr 9, 2007	SUPPL -7	View Letter (PDF)
Feb 2, 2007	SUPPL -6	View Letter (PDF)
Jul 21, 2006	SUPPL -3	View Letter (PDF)
Jul 21, 2006	SUPPL -4	View Letter (PDF)
Jun 21, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

RLDAP

6 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 15, 2005

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7879828	Feb 5, 2029	—	—	Yes	—	—
8372995	Oct 8, 2030	—	—	Yes	—	—
8975242	Oct 24, 2028	—	—	Yes	—	—
9254328	Mar 13, 2026	—	—	Yes	—	—
9694078	Mar 13, 2026	—	—	Yes	—	—
10588975	Mar 13, 2026	—	—	Yes	—	—