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PROMACTA KIT Drug Profile
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» See Plans and PricingWhich patents cover Promacta Kit, and what generic alternatives are available?
Promacta Kit is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and fourteen patent family members in thirty-one countries.
The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
US ANDA Litigation and Generic Entry Outlook for Promacta Kit
Indicators of Generic Entry
Summary for PROMACTA KIT
| International Patents: | 114 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 27 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PROMACTA KIT at DailyMed |
Recent Clinical Trials for PROMACTA KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shenzhen Second People's Hospital | Phase 3 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 4 |
| Wei Zhao | Phase 4 |
Pharmacology for PROMACTA KIT
US Patents and Regulatory Information for PROMACTA KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 PROMACTA KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20025566 | Start Trial |
| Taiwan | I305207 | Start Trial |
| Canada | 2308316 | Start Trial |
| Czech Republic | 303176 | Start Trial |
| Canada | 2308135 | Start Trial |
| Norway | 330160 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1294378 | 388 | Finland | Start Trial | |
| 1294378 | C01294378/01 | Switzerland | Start Trial | FORMER OWNER: GLAXOSMITHKLINE LLC, US |
| 1294378 | SPC/GB10/026 | United Kingdom | Start Trial | PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315 |
| 1534390 | PA2010007,C1534390 | Lithuania | Start Trial | PRODUCT NAME: ELTROMBOPAGO OLAMINAS; REGISTRATION NO/DATE: EU/1/10/612/001, 2010-03-11 EU/1/10/612/002, 2010-03-11 EU/1/10/612/003, 2010-03-11 EU/1/10/612/004, 2010-03-11 EU/1/10/612/005, 2010-03-11 EU/1/10/612/006 20100311 |
| 1294378 | C201000022 | Spain | Start Trial | PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 20100315 |
| 1294378 | 300451 | Netherlands | Start Trial | PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100315 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
