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. Seven 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.
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Summary for TIGECYCLINE
| International Patents: | 8 |
| US Patents: | 1 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 59 |
| Patent Applications: | 4,397 |
| 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 |
|---|---|
| Tata Memorial Centre | Phase 2 |
| Anhui Chest Hospital | Phase 4 |
| Zhengzhou Sixth People's Hospital, 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
| 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 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | TIGECYCLINE | tigecycline | POWDER;INTRAVENOUS | 091620-001 | May 27, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | TIGECYCLINE | tigecycline | POWDER;INTRAVENOUS | 206335-001 | Jun 11, 2019 | 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 | ||
| >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 | ⤷ Sign Up | |
| Poland | 2881109 | ⤷ Sign Up | |
| Spain | 2795421 | ⤷ Sign Up | |
| China | 103315947 | Tigecycline composition for injection | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014135531 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TIGECYCLINE
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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