BALOXAVIR MARBOXIL - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for baloxavir marboxil and what is the scope of freedom to operate?
Baloxavir marboxil
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Baloxavir marboxil has one hundred and ninety-seven patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for BALOXAVIR MARBOXIL
International Patents: | 197 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 10 |
Patent Applications: | 239 |
What excipients (inactive ingredients) are in BALOXAVIR MARBOXIL? | BALOXAVIR MARBOXIL excipients list |
DailyMed Link: | BALOXAVIR MARBOXIL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BALOXAVIR MARBOXIL
Generic Entry Dates for BALOXAVIR MARBOXIL*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for BALOXAVIR MARBOXIL*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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 BALOXAVIR MARBOXIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Weill Medical College of Cornell University | Phase 4 |
M.D. Anderson Cancer Center | Phase 2 |
University of Washington | Phase 4 |
Pharmacology for BALOXAVIR MARBOXIL
Drug Class | Polymerase Acidic Endonuclease Inhibitor |
Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Paragraph IV (Patent) Challenges for BALOXAVIR MARBOXIL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XOFLUZA | Tablets | baloxavir marboxil | 40 mg and 80 mg | 210854 | 1 | 2022-10-24 |
US Patents and Regulatory Information for BALOXAVIR MARBOXIL
EU/EMA Drug Approvals for BALOXAVIR MARBOXIL
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Xofluza | baloxavir marboxil | EMEA/H/C/004974 Treatment of influenzaXofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above.Post exposure prophylaxis of influenzaXofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above.Xofluza should be used in accordance with official recommendations. |
Authorised | no | no | no | 2021-01-07 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BALOXAVIR MARBOXIL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2938877 | ⤷ Try a Trial | |
Hong Kong | 1259624 | 抗流感多環吡啶酮衍生物及其前藥 (ANTI-INFLUENZA POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF) | ⤷ Try a Trial |
Brazil | 112013006722 | profármaco de derivado de carbamoilpiridona policíclica substituída | ⤷ Try a Trial |
Taiwan | I518085 | ⤷ Try a Trial | |
Japan | WO2012039414 | 置換された多環性カルバモイルピリドン誘導体のプロドラッグ | ⤷ Try a Trial |
Ukraine | 123725 | ЗАМІЩЕНІ ПОЛІЦИКЛІЧНІ ПОХІДНІ ПІРИДОНУ ТА ЇХ ПРОЛІКИ (SUBSTITUTED POLYCYCLIC PYRIDONE DERIVATIVE AND PRODRUG THEREOF) | ⤷ Try a Trial |
New Zealand | 736259 | Substituted polycyclic pyridone derivative and prodrugs thereof | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BALOXAVIR MARBOXIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2620436 | PA2021505 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BALOKSAVIRO MARBOKSILAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/20/1500 20210107 |
2620436 | CR 2021 00004 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108 |
2620436 | CA 2021 00004 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIR MARBOXIL ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1500 20210108 |
2620436 | 132021000000038 | Italy | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIR MARBOXIL O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(XOFLUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1500, 20210108 |
2620436 | C02620436/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIRUM MARBOXILUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67426 21.02.2020 |
2620436 | 301093 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIR MARBOXIL, ALSMEDE FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1500 20210108 |
2620436 | 122021000017 | Germany | ⤷ Try a Trial | PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.