Tigecycline - Generic Drug Details

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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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	59
Patent Applications:	6,731
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
Tata Memorial Centre	Phase 2
No.85 Hospital, Changning, Shanghai, China	Phase 4
Shanghai Pudong New Area Pulmonary Hospital, China	Phase 4

See all tigecycline clinical trials

Pharmacology for tigecycline

Drug Class	Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for tigecycline

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

US Patents and Regulatory Information for tigecycline

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Glossary

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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
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Meitheal	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	214020-001	May 13, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205722-001	Oct 18, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	211158-001	Aug 2, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Apotex	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	204439-001	Dec 21, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for tigecycline

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

EU/EMA Drug Approvals for tigecycline

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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

International Patents for tigecycline

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Country	Patent Number	Title	Estimated Expiration
Costa Rica	9416	TIGECYCLINE COMPOSITIONS AND METHODS OF PREPARATION	⤷ Sign Up
Cyprus	1114253		⤷ Sign Up
China	102512429	Tigecycline compositions and methods of preparation	⤷ Sign Up
Japan	2008545717		⤷ Sign Up
Russian Federation	2478612	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (CRYSTALLINE FORMS OF TIGECYCLINE AND METHOD FOR PREPARING THEM)	⤷ Sign Up
Canada	2879383	COMPOSITION DE TIGECYCLINE DESTINEE A ETRE INJECTEE (TIGECYCLINE COMPOSITION FOR INJECTION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tigecycline

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	06C0031	France	⤷ Sign Up	PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515	SPC/GB06/033	United Kingdom	⤷ Sign Up	PRODUCT NAME: TIGECYCLINE
0536515	C300244	Netherlands	⤷ Sign Up	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	⤷ Sign Up	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	⤷ Sign Up	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

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