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 |
---|---|
Cangzhou Central Hospital | Phase 4 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 4 |
Institute of Hematology & Blood Diseases 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 | 022291-004 | Oct 20, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | 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 | 022291-002 | Nov 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ 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 |
---|---|---|---|
China | 101686930 | Novel pharmaceutical composition | ⤷ Try a Trial |
Japan | 2015129195 | 新たな医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION) | ⤷ Try a Trial |
Peru | 20121407 | COMPOSICION FARMACEUTICA QUE COMPRENDE BIS-(MONOETANOLAMINA) DE 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 | ⤷ Try a Trial |
Japan | 2023011888 | 新たな医薬組成物 | ⤷ 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 | 122010000037 | Germany | ⤷ Try a 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 | ⤷ Try a Trial | 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 |
1534390 | 91 3-2010 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315 |
1294378 | 2010C/018 | Belgium | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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