TYGACIL Drug Patent Profile
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Which patents cover Tygacil, and when can generic versions of Tygacil launch?
Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. There are six patents protecting this drug.
This drug has sixty-two patent family members in twenty-nine countries.
The generic ingredient in TYGACIL 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 Tygacil
A generic version of TYGACIL was approved as tigecycline by SANDOZ on May 27th, 2015.
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Summary for TYGACIL
International Patents: | 62 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 16 |
Patent Applications: | 4,763 |
Drug Prices: | Drug price information for TYGACIL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYGACIL |
What excipients (inactive ingredients) are in TYGACIL? | TYGACIL excipients list |
DailyMed Link: | TYGACIL at DailyMed |
Recent Clinical Trials for TYGACIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zhujiang Hospital | |
Pfizer | Phase 4 |
Manjunath Prakash Pai | Phase 4 |
Pharmacology for TYGACIL
Drug Class | Tetracycline-class Antibacterial |
US Patents and Regulatory Information for TYGACIL
TYGACIL is protected by six US patents.
Patents protecting TYGACIL
Tigecycline compositions and methods of preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tigecycline compositions and methods of preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline solid forms of tigecycline and methods of preparing same
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Patent Expiration: ⤷ Sign Up
Tigecycline compositions and methods of preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tigecycline compositions and methods of preparation
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Patent Expiration: ⤷ Sign Up
Tigecycline compositions and methods of preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ||
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 | ||
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 | ||
>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 TYGACIL
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 TYGACIL
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 TYGACIL
See the table below for patents covering TYGACIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20070024 | FORMAS SOLIDAS CRISTALINAS DE TIGECICLINA Y METODOS PARA PREPARAR LAS MISMAS | ⤷ Sign Up |
Honduras | 2006011218 | COMPOSICIONES DE TIGECICLINA Y MÉTODOS DE PREPARACIÓN | ⤷ Sign Up |
Cyprus | 1114253 | ⤷ Sign Up | |
Norway | 923857 | ⤷ Sign Up | |
South Korea | 20080016890 | CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHODS OF PREPARING SAME | ⤷ Sign Up |
Russian Federation | 2007143160 | КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYGACIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0536515 | CA 2006 00027 | Denmark | ⤷ Sign Up | |
0536515 | 34/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: TIGECYCLIN UND DIE PHARMAKOLOGISCH UNBEDENKLICHEN ORGANISCHEN UND ANORGANISCHEN SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/336/001 20060424 |
0536515 | C00536515/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: WYETH HOLDINGS CORPORATION, US |
0536515 | SPC/GB06/033 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TIGECYCLINE |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |