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 |
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 | ⤷ 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 | ||
| 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 |
|---|---|---|---|
| Russian Federation | 2010107169 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОПТИЧЕСКИ АКТИВНОЕ СОЕДИНЕНИЕ, ОБЛАДАЮЩЕЕ АКТИВНОСТЬЮ АГОНИСТА РЕЦЕПТОРА ТРОМБОПОЭТИНА, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ ДЛЯ ЭТОГО | ⤷ Try a Trial |
| South Korea | 20130115257 | PREPARATION FOR IMPROVING SOLLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Try a Trial |
| Spain | 2599529 | ⤷ Try a Trial | |
| China | 103130739 | Compounds having thrombopoietin receptor agonism | ⤷ 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 | 122019000065 | Germany | ⤷ Try a Trial | PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218 |
| 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
