TYGACIL Drug Patent Profile

Which patents cover Tygacil, and when can generic versions of Tygacil launch?

Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tygacil

A generic version of TYGACIL was approved as tigecycline by SANDOZ INC on May 27^th, 2015.

Summary for TYGACIL

International Patents:	62
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	16
Patent Applications:	5,092
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TYGACIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYGACIL
What excipients (inactive ingredients) are in TYGACIL?	TYGACIL excipients list
DailyMed Link:	TYGACIL at DailyMed

See drug prices for TYGACIL

Recent Clinical Trials for TYGACIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zhujiang Hospital
Pfizer	Phase 4
Manjunath Prakash Pai	Phase 4

See all TYGACIL clinical trials

Pharmacology for TYGACIL

Drug Class

Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for TYGACIL

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TYGACIL

TYGACIL is protected by six US patents.

Patents protecting TYGACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y

Expired US Patents for TYGACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005

International Patents for TYGACIL

See the table below for patents covering TYGACIL around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	244585	9-SUBSTITUTED-AMINO TETRACYCLINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Argentina	057649	FORMAS SOLIDAS CRISTALINAS DE TIGECICLINA Y METODOS PARA PREPARAR LAS MISMAS
Taiwan	200720232	Crystalline solid forms of tigecycline and methods of preparing same
Ecuador	SP078055	FORMAS SÓLIDAS CRISTALINAS DE TIGECICLINA Y MÉTODOS PARA PREPARAR LAS MISMAS
Russian Federation	2478612	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (CRYSTALLINE FORMS OF TIGECYCLINE AND METHOD FOR PREPARING THEM)
Denmark	1858488
Guatemala	200600112	COMPOSICIIONES DE TIGECICLINA Y METODOS DE PREPARACION

Supplementary Protection Certificates for TYGACIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	SPC030/2006	Ireland		SPC030/2006: 20071025, EXPIRES: 20170820
0536515	0690028-6	Sweden		PRODUCT NAME: TIGECYKLIN
0536515	C300244	Netherlands		PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
0536515	91279	Luxembourg		91279, EXPIRES: 20170821
0536515	34/2006	Austria		PRODUCT NAME: TIGECYCLIN UND DIE PHARMAKOLOGISCH UNBEDENKLICHEN ORGANISCHEN UND ANORGANISCHEN SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515	2006/030	Ireland		PRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515	C00536515/01	Switzerland		FORMER OWNER: WYETH HOLDINGS CORPORATION, US