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
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 | 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 | ⤷ 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 | 103396313 | Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity and intermediate thereof | ⤷ Try a Trial |
| Taiwan | I356056 | ⤷ Try a Trial | |
| European Patent Office | 1655291 | COMPOSES AGONISTES DU RECEPTEUR DE LA THROMBOPOIETINE (COMPOUNDS HAVING THROMBOPOIETIN RECEPTOR AGONISM) | ⤷ Try a Trial |
| Japan | 2014141518 | PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Try a Trial |
| European Patent Office | 2184279 | COMPOSITION PHARMACEUTIQUE CONTENANT UN COMPOSÉ ACTIF SUR LE PLAN OPTIQUE POSSÉDANT UNE ACTIVITÉ D'AGONISTE DU RÉCEPTEUR DE LA THROMBOPOÏÉTINE ET SON INTERMÉDIAIRE (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF) | ⤷ 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 | 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 | 2019/039 | Ireland | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/18/1348 20190218 |
| 2184279 | C201930048 | Spain | ⤷ Try a Trial | 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 | SPC/GB19/049 | United Kingdom | ⤷ Try a Trial | 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 | 300998 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG OF FARMACEUTISCH AANVAARDBARE ZOUTEN OF SOLVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1348 20190220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
