TIGECYCLINE Drug Patent Profile

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Tigecycline is a drug marketed by Accord Hlthcare Inc, Amneal, Apotex, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, and Xellia Pharms Aps. and is included in eight NDAs. There is one patent protecting this drug.

This drug has eight patent family members in eight countries.

The generic ingredient in TIGECYCLINE 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.

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

International Patents:	8
US Patents:	1
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	58
Patent Applications:	4,397
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

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

Sponsor	Phase
Zhengzhou Sixth People's Hospital, China	Phase 4
No.85 Hospital, Changning, Shanghai, China	Phase 4
Shanghai Pudong New Area Pulmonary Hospital, China	Phase 4

Drug Class	Tetracycline-class Antibacterial

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

TIGECYCLINE is protected by one US patents.

Tigecycline composition for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare Inc	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	208744-001	Jan 18, 2018		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	091620-001	May 27, 2015	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	206335-001	Jun 11, 2019	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xellia Pharms Aps	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205722-001	Oct 18, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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

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Country	Patent Number	Title	Estimated Expiration
Germany	102013203648	VERFAHREN UND VORRICHTUNG ZUR PLASMABEHANDLUNG VON HOHLKÖRPERN	⤷ Try a Trial
European Patent Office	2964274	PROCÉDÉ ET DISPOSITIF SERVANT AU TRAITEMENT PAR PLASMA DE CORPS CREUX (METHOD AND DEVICE FOR PLASMA-TREATING HOLLOW BODIES)	⤷ Try a Trial
Russian Federation	2015100116	ТИГЕЦИКЛИНОВАЯ КОМПОЗИЦИЯ ДЛЯ ИНЪЕКЦИИ	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014135531		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	06C0031	France	⤷ Try a Trial	PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515	C300244	Netherlands	⤷ Try a Trial	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	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description