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PROMACTA Drug Profile
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When do Promacta patents expire, and what generic alternatives are available?
Promacta is a drug marketed by Novartis and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and ninety-three patent family members in forty-one countries.
The generic ingredient in PROMACTA 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
Promacta was eligible for patent challenges on November 20th, 2012.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Summary for PROMACTA
| International Patents: | 193 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 146 |
| Clinical Trials: | 27 |
| Patent Applications: | 557 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROMACTA |
| DailyMed Link: | PROMACTA at DailyMed |
Recent Clinical Trials for PROMACTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shenzhen Second People's Hospital | Phase 3 |
| Wei Zhao | Phase 4 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 4 |
Pharmacology for PROMACTA
Paragraph IV (Patent) Challenges for PROMACTA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROMACTA | TABLET;ORAL | eltrombopag olamine | 022291 | 2014-02-04 |
| PROMACTA | TABLET;ORAL | eltrombopag olamine | 022291 | 2014-01-07 |
US Patents and Regulatory Information for PROMACTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | Start Trial | Start Trial | 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 | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | Start Trial | Start Trial |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | Start Trial | Start Trial |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | Start Trial | Start Trial |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | 227476 | Start Trial |
| Cyprus | 1109435 | Start Trial |
| Germany | 122010000037 | Start Trial |
| Brazil | 0310094 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1294378 | 2010C/018 | Belgium | Start Trial | PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315 |
| 1294378 | C300451 | Netherlands | Start Trial | PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311 |
| 1294378 | 122010000037 | Germany | Start Trial | PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311 |
| 1294378 | 23/2010 | Austria | Start Trial | PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
