drug · small molecule

baloxavir marboxil

Marketedupdated 3mo ago

by $SGIOF SHIONOGI & CO LTD🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for influenza and viral disease.

targets

Polymerase acidic protein

all catalysts(0)

nothing on the calendar yet

Trials studying baloxavir marboxil

phase3A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contactsrecruitingn=750
phase3Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenzacompletedn=190
phase4Xofluza-Wearables Feasibility-Studycompletedn=498
phase3Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Householdscompletedn=4,138
phase3Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptomscompletedn=100
phase3Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenzaterminatedn=2
phase3Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptomscompletedn=49

Patent cliff

source: FDA Orange Book

first barrier falls

Dec 19, 2027

~1.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (54)

Apr 21, 2041formulationUS 11925648
Apr 21, 2041formulationUS 11925648
Apr 21, 2041formulationUS 11925648
Oct 9, 2039formulationUS 12064438
Oct 9, 2039formulationUS 12064438
Oct 9, 2039formulationUS 12064438
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-2816)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y

FDA exclusivities (4)

Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y

News(1)

FDA Approves First Single-Dose Generic Treatment for Influenza
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in…
fda_press · 1mo ago

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 1h ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

drug · small molecule

save

baloxavir marboxil

Marketedupdated 3mo ago

by $SGIOF SHIONOGI & CO LTD🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for influenza and viral disease.

targets

Polymerase acidic protein

all catalysts(0)

nothing on the calendar yet

Trials studying baloxavir marboxil

phase3A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contactsrecruitingn=750
phase3Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenzacompletedn=190
phase4Xofluza-Wearables Feasibility-Studycompletedn=498
phase3Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Householdscompletedn=4,138
phase3Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptomscompletedn=100
phase3Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenzaterminatedn=2
phase3Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptomscompletedn=49

Patent cliff

source: FDA Orange Book

first barrier falls

Dec 19, 2027

~1.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (54)

Apr 21, 2041formulationUS 11925648
Apr 21, 2041formulationUS 11925648
Apr 21, 2041formulationUS 11925648
Oct 9, 2039formulationUS 12064438
Oct 9, 2039formulationUS 12064438
Oct 9, 2039formulationUS 12064438
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Sep 25, 2038formulationUS 11261198
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037compositionUS 10759814
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-2816)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Aug 9, 2037method-of-use (U-3000)US 11306106
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036compositionUS 10392406
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-3000)US 10633397
Apr 27, 2036method-of-use (U-2816)US 10633397
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
Oct 24, 2032compositionUS 8987441
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
May 5, 2031formulationUS 89277104.7y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y
Jun 14, 2030formulationUS 98158353.8y

FDA exclusivities (4)

Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y
Dec 19, 2027M-187Method (3y)1.4y

News(1)

FDA Approves First Single-Dose Generic Treatment for Influenza
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in…
fda_press · 1mo ago

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 1h ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

baloxavir marboxil

targets

all catalysts(0)

Trials studying baloxavir marboxil

Patent cliff

patents (54)

FDA exclusivities (4)

News(1)

Report a data issue

comments(0)

baloxavir marboxil

targets

all catalysts(0)

Trials studying baloxavir marboxil

Patent cliff

patents (54)

FDA exclusivities (4)

News(1)

Report a data issue

comments(0)