Eltrombopag olamine - Generic Drug Details
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What are the generic sources for eltrombopag olamine and what is the scope of patent protection?
Eltrombopag olamine
is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Eltrombopag olamine has one hundred and eight patent family members in forty countries.
There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.
Summary for eltrombopag olamine
International Patents: | 108 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 15 |
Patent Applications: | 564 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eltrombopag olamine |
What excipients (inactive ingredients) are in eltrombopag olamine? | eltrombopag olamine excipients list |
DailyMed Link: | eltrombopag olamine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eltrombopag olamine
Generic Entry Dates for eltrombopag olamine*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;ORAL |
Generic Entry Dates for eltrombopag olamine*:
Constraining patent/regulatory exclusivity:
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 eltrombopag olamine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Second Affiliated Hospital of Guangzhou Medical University | Phase 4 |
The Second Affiliated Hospital of Kunming Medical University | Phase 4 |
Daqing Oil Field Hospital | Phase 4 |
Pharmacology for eltrombopag olamine
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROMACTA KIT | For Oral Suspension | eltrombopag olamine | 12. mg/packet and 25 mg/packet | 207027 | 1 | 2022-04-22 |
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 eltrombopag olamine
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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 eltrombopag olamine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for eltrombopag olamine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 059656 | COMPRIMIDO FARMACEUTICO QUE COMPRENDE LA SAL DE BIS - (MONOETANOLAMINA) DEL ACIDO 3' -[(2Z )-[1-(3,4- DIMETILFENIL)-1,5- DIHIDRO-3- METIL-5 OXO- 4H-PIRAZOL-4- ILIDENO} HIDRAZINO} -2' HIDROXI- { 1,1'- BIFENIL]-3- CARBOXILICO [ELTROMBOPAG OLAMINA), CAPSULA FARMACEUTICA, FORMA DE DOSIFICACION Y GRANULO | ⤷ Try a Trial |
South Korea | 20100020456 | NOVEL PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
Hong Kong | 1136968 | 新穎的藥物組合物 (NOVEL PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for eltrombopag olamine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1294378 | 300451 | Netherlands | ⤷ Try a 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 |
1534390 | PA2010007,C1534390 | Lithuania | ⤷ Try a 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 | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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