TIGECYCLINE - Generic Drug Details

What are the generic sources for tigecycline and what is the scope of patent protection?

Tigecycline is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Amneal, Apotex, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, Xellia Pharms Aps, and Pf Prism Cv, and is included in nine NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tigecycline has seventy patent family members in twenty-nine countries.

There are ten drug master file entries for tigecycline. Eight suppliers are listed for this compound.

Summary for TIGECYCLINE

International Patents:	70
US Patents:	7
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	58
Patent Applications:	6,731
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for TIGECYCLINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIGECYCLINE
What excipients (inactive ingredients) are in TIGECYCLINE?	TIGECYCLINE excipients list
DailyMed Link:	TIGECYCLINE at DailyMed

See drug prices for TIGECYCLINE

Recent Clinical Trials for TIGECYCLINE

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

Sponsor	Phase
Anhui Chest Hospital	Phase 4
Zhengzhou Sixth People's Hospital, China	Phase 4
No.85 Hospital, Changning, Shanghai, China	Phase 4

See all TIGECYCLINE clinical trials

Pharmacology for TIGECYCLINE

Drug Class

Tetracycline-class Antibacterial

US Patents and Regulatory Information for TIGECYCLINE

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
Sandoz	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	091620-001	May 27, 2015	AP	RX	No	No
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Amneal	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	211158-001	Aug 2, 2018	AP	RX	No	No			Y
Eugia Pharma	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	206335-001	Jun 11, 2019	AP	RX	No	No

Expired US Patents for TIGECYCLINE

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

EU/EMA Drug Approvals for TIGECYCLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Tigecycline Accord	tigecycline	EMEA/H/C/005114 Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4)Complicated intra-abdominal infections (cIAI)Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	yes	no	no	2020-04-17
Pfizer Europe MA EEIG	Tygacil	tigecycline	EMEA/H/C/000644 Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections:, , , Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections, Complicated intra-abdominal infections (cIAI), , , Tygacil should be used only in situations where other alternative antibiotics are not suitable., , Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.,	Authorised	no	no	no	2006-04-24

International Patents for TIGECYCLINE

Country	Patent Number	Title	Estimated Expiration
Portugal	1890996
Canada	2609875	FORMES SOLIDES CRISTALLINES DE TIGECYCLINE ET PROCEDES DE PREPARATION DE CELLES-CI (CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHODS OF PREPARING SAME)
South Korea	20130122988	TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION
European Patent Office	1858488	COMPOSITIONS DE TIGECYCLINE ET LEURS METHODES DE PREPARATION (TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION)
Israel	185924	תכשירים טיגיציקלנים ושיטות להכנה (Tigecycline compositions and methods of preparation)

Supplementary Protection Certificates for TIGECYCLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	06C0031	France		PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
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	300244	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	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	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE