PROMACTA Drug Patent 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 six patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty-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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Promacta
A generic version of PROMACTA was approved as eltrombopag olamine by ANNORA PHARMA on April 18th, 2024.
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Questions you can ask:
- What is the 5 year forecast for PROMACTA?
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- What is Average Wholesale Price for PROMACTA?
Summary for PROMACTA
International Patents: | 123 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 31 |
Patent Applications: | 249 |
Drug Prices: | Drug price information for PROMACTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROMACTA |
What excipients (inactive ingredients) are in PROMACTA? | PROMACTA excipients list |
DailyMed Link: | PROMACTA at DailyMed |


Recent Clinical Trials for PROMACTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
Anjali Pawar | Phase 1 |
Pharmacology for PROMACTA
Paragraph IV (Patent) Challenges for PROMACTA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROMACTA | Tablets | eltrombopag olamine | 12.5 mg and 25 mg | 022291 | 1 | 2014-02-04 |
PROMACTA | Tablets | eltrombopag olamine | 50 mg and 75 mg | 022291 | 1 | 2014-01-07 |
US Patents and Regulatory Information for PROMACTA
PROMACTA is protected by six US patents and one FDA Regulatory Exclusivity.
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 | 022291-003 | Sep 8, 2009 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | DISCN | Yes | No | 7,547,719*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | AB | RX | Yes | Yes | 7,547,719*PED | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 022291-005 | Nov 16, 2012 | 7,790,704*PED | ⤷ Try for Free |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | 7,160,870*PED | ⤷ Try for Free |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | 7,452,874*PED | ⤷ Try for Free |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | 7,795,293*PED | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA
When does loss-of-exclusivity occur for PROMACTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9656
Estimated Expiration: ⤷ Try for Free
Patent: 7711
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 07352608
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0721651
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 85831
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 07002242
Estimated Expiration: ⤷ Try for Free
China
Patent: 1686930
Estimated Expiration: ⤷ Try for Free
Patent: 2688207
Estimated Expiration: ⤷ Try for Free
Patent: 2697745
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 60058
Estimated Expiration: ⤷ Try for Free
Costa Rica
Patent: 143
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0160206
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 17284
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 52237
Estimated Expiration: ⤷ Try for Free
Dominican Republic
Patent: 009000253
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 077628
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 0883
Estimated Expiration: ⤷ Try for Free
Patent: 4294
Estimated Expiration: ⤷ Try for Free
Patent: 0971018
Estimated Expiration: ⤷ Try for Free
Patent: 1400387
Estimated Expiration: ⤷ Try for Free
Patent: 1991590
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 52237
Estimated Expiration: ⤷ Try for Free
Patent: 90730
Estimated Expiration: ⤷ Try for Free
Patent: 18732
Estimated Expiration: ⤷ Try for Free
Patent: 18733
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 36968
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 27209
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 1891
Estimated Expiration: ⤷ Try for Free
Patent: 8840
Estimated Expiration: ⤷ Try for Free
Patent: 4602
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 19866
Estimated Expiration: ⤷ Try for Free
Patent: 35078
Estimated Expiration: ⤷ Try for Free
Patent: 44713
Estimated Expiration: ⤷ Try for Free
Patent: 60289
Estimated Expiration: ⤷ Try for Free
Patent: 10526140
Estimated Expiration: ⤷ Try for Free
Patent: 14005302
Estimated Expiration: ⤷ Try for Free
Patent: 15129195
Estimated Expiration: ⤷ Try for Free
Patent: 17137343
Estimated Expiration: ⤷ Try for Free
Patent: 19123747
Estimated Expiration: ⤷ Try for Free
Patent: 21100968
Estimated Expiration: ⤷ Try for Free
Patent: 23011888
Estimated Expiration: ⤷ Try for Free
Jordan
Patent: 43
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 8072
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 09011881
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 236
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 0888
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 080773
Estimated Expiration: ⤷ Try for Free
Patent: 121407
Estimated Expiration: ⤷ Try for Free
Patent: 151953
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 52237
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 52237
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 52237
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 0907710
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1475971
Estimated Expiration: ⤷ Try for Free
Patent: 1537200
Estimated Expiration: ⤷ Try for Free
Patent: 1632851
Estimated Expiration: ⤷ Try for Free
Patent: 100020456
Estimated Expiration: ⤷ Try for Free
Patent: 140049086
Estimated Expiration: ⤷ Try for Free
Patent: 150008513
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 65179
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 39267
Estimated Expiration: ⤷ Try for Free
Patent: 38674
Estimated Expiration: ⤷ Try for Free
Patent: 0843742
Estimated Expiration: ⤷ Try for Free
Patent: 1410240
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 261
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PROMACTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 030696 | DERIVADOS DE HIDROXI-1-AZOBENCENO, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN, USO DE DICHOS COMPUESTOS EN LA FABRICACION DE MEDICAMENTOS, PROCESO PARA PREPARAR DICHAS COMPOSICIONES, PROCESO PARA PREPARAR DICHOS COMPUESTOS, METODO IN VITRO O EX VIVO PARA AUMENTAR LA ESTIMULACION DE LA MADURACION | ⤷ Try for Free |
European Patent Office | 1294378 | COMPOSÉS MIMETIQUES DE THROMBOPOIETINE (THROMBOPOIETIN MIMETICS) | ⤷ Try for Free |
Israel | 274602 | טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia) | ⤷ Try for Free |
South Korea | 20110113216 | 3'-[(2Z)-[1-(3,4-DIMETHYLPHENYL)-1,5-DIHYDRO-3-METHYL-5-OXO-4H-PYRAZOL-4-YLIDENE]HYDRAZINO]-2'-HYDROXY-[1,1'-BIPHENYL]-3-CARBOXYLIC ACID BIS-(MONOETHANOLAMINE) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1294378 | 2010/020 | Ireland | ⤷ Try for Free | 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 |
1294378 | 300451 | Netherlands | ⤷ Try for Free | 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 |
1534390 | C20100006 | Estonia | ⤷ Try for Free | PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019 |
1294378 | SPC/GB10/026 | United Kingdom | ⤷ Try for Free | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Promacta
More… ↓