LUSUTROMBOPAG - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for lusutrombopag and what is the scope of freedom to operate?
Lusutrombopag
is the generic ingredient in one branded drug marketed by Vancocin Italia and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lusutrombopag has fifty-six patent family members in twenty countries.
One supplier is listed for this compound.
Summary for LUSUTROMBOPAG
International Patents: | 56 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 3 |
Patent Applications: | 45 |
What excipients (inactive ingredients) are in LUSUTROMBOPAG? | LUSUTROMBOPAG excipients list |
DailyMed Link: | LUSUTROMBOPAG at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUSUTROMBOPAG
Generic Entry Date for LUSUTROMBOPAG*:
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 LUSUTROMBOPAG
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shionogi | Phase 3 |
Shionogi | Phase 2 |
US Patents and Regulatory Information for LUSUTROMBOPAG
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 |
EU/EMA Drug Approvals for LUSUTROMBOPAG
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Shionogi B.V. | Mulpleo (previously Lusutrombopag Shionogi) | lusutrombopag | EMEA/H/C/004720 Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures |
Authorised | no | no | no | 2019-02-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LUSUTROMBOPAG
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103130739 | Compounds having thrombopoietin receptor agonism | ⤷ Try a Trial |
South Korea | 20130115257 | PREPARATION FOR IMPROVING SOLLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Try a Trial |
Japan | WO2009017098 | トロンボポエチン受容体アゴニスト作用を有する光学活性な化合物を含有する医薬組成物およびその中間体 | ⤷ Try a Trial |
Denmark | 2184279 | ⤷ Try a Trial | |
Japan | 2014141518 | PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Try a Trial |
Japan | 2008110998 | COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONISM | ⤷ Try a Trial |
European Patent Office | 2623100 | PRÉPARATION POUR AMÉLIORER LA SOLUBILITÉ D'UN MÉDICAMENT MÉDIOCREMENT SOLUBLE (PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUSUTROMBOPAG
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2184279 | CR 2019 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220 |
2184279 | 1990035-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220 |
2184279 | 19C1043 | France | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG, UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1348 20190220 |
2184279 | CA 2019 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220 |
2184279 | 122019000065 | Germany | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218 |
2184279 | 132019000000090 | Italy | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG(LUSUTROMBOPAG SHIONOGI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1348, 20190220 |
2184279 | 2019C/534 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |