By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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PROMACTA Drug Profile
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Which patents cover Promacta, and what generic alternatives are available?
Promacta is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and seventy-six 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.
DrugPatentWatch® Generic Entry Outlook for Promacta
Promacta was eligible for patent challenges on November 20, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for PROMACTA
| International Patents: | 176 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,385 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROMACTA |
| What excipients (inactive ingredients) are in PROMACTA? | PROMACTA excipients list |
| DailyMed Link: | PROMACTA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for PROMACTA
Generic Entry Date for PROMACTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PROMACTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Food and Drug Administration (FDA) | Phase 1 |
| University of California, San Francisco | Phase 1 |
| University of California, Davis | Phase 1 |
Pharmacology for PROMACTA
ATC Classes 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
Expired US Patents for PROMACTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | Try Before You Buy | Try Before You Buy |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | Try Before You Buy | Try Before You Buy |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | Try Before You Buy | Try Before You Buy |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | Try Before You Buy | Try Before You Buy |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2152237 | Try Before You Buy |
| Canada | 2308135 | Try Before You Buy |
| Hungary | 0302257 | Try Before You Buy |
| Hong Kong | 1078039 | Try Before You Buy |
| New Zealand | 533308 | Try Before You Buy |
| Morocco | 30236 | Try Before You Buy |
| Japan | 2010265317 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1294378 | C01294378/01 | Switzerland | Try Before You Buy | FORMER OWNER: GLAXOSMITHKLINE LLC, US |
| 1534390 | PA2010007,C1534390 | Lithuania | Try Before You Buy | 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 | 2010/020 | Ireland | Try Before You Buy | PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311 |
| 1534390 | C 2010 013 | Romania | Try Before You Buy | PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311 |
| 1294378 | 23/2010 | Austria | Try Before You Buy | PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 20100315 |
| 1294378 | 2010C/018 | Belgium | Try Before You Buy | 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 |
| 1534390 | PA2010007 | Lithuania | Try Before You Buy | PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
