Lusutrombopag - Generic Drug Details
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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
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for lusutrombopag
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 lusutrombopag
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
|---|---|---|---|
| South Korea | 101849808 | ⤷ Sign Up | |
| Mexico | 2010001082 | COMPOSICION FARMACEUTICA QUE CONTIENE COMPUESTO OPTICAMENTE ACTIVO QUE TIENE ACTIVIDAD AGONISTA DEL RECEPTOR DE TROMBOPOYETINA Y COMPUESTO INTERMEDIO PARA EL MISMO. (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2012043709 | ⤷ Sign Up | |
| Japan | 2014141518 | PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lusutrombopag
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2184279 | SPC/GB19/049 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1348(FOR NI) 20190220; UK PLGB 50999/0007 20190220 |
| 2184279 | CA 2019 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220 |
| 2184279 | C201930048 | Spain | ⤷ Sign Up | PRODUCT NAME: LUSUTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/01/18/1348; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/01/18/1348; DATE OF FIRST AUTHORISATION IN EEA: 20190218 |
| 2184279 | 1990035-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
