TIGECYCLINE Drug Patent Profile
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Which patents cover Tigecycline, and when can generic versions of Tigecycline launch?
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tigecycline
A generic version of TIGECYCLINE was approved as tigecycline by SANDOZ on May 27th, 2015.
Summary for TIGECYCLINE
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 |
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 |
Pharmacology for TIGECYCLINE
Drug Class | Tetracycline-class Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for TIGECYCLINE
US Patents and Regulatory Information for TIGECYCLINE
TIGECYCLINE is protected by one US patents.
Patents protecting TIGECYCLINE
Tigecycline composition for injection
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TIGECYCLINE
See the table below for patents covering TIGECYCLINE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2881109 | ⤷ Try a Trial | |
China | 103315947 | Tigecycline composition for injection | ⤷ Try a Trial |
Canada | 2879383 | COMPOSITION DE TIGECYCLINE DESTINEE A ETRE INJECTEE (TIGECYCLINE COMPOSITION FOR INJECTION) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2014135531 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIGECYCLINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0536515 | SPC/GB06/033 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TIGECYCLINE |
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 | 06C0031 | France | ⤷ Try a Trial | PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 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 |