Last Updated: September 26, 2026

Details for New Drug Application (NDA): 211929


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NDA 211929 describes ORTIKOS, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the ORTIKOS profile page.

The generic ingredient in ORTIKOS is budesonide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 211929
Tradename:ORTIKOS
Applicant:Sun Pharm Inds Inc
Ingredient:budesonide
Patents:2
Medical Subject Heading (MeSH) Categories for 211929
Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED RELEASE;ORALStrength6MG
Approval Date:Jun 13, 2019TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Sep 9, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON
Patent:⤷  Start TrialPatent Expiration:Sep 9, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED RELEASE;ORALStrength9MG
Approval Date:Jun 13, 2019TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Sep 9, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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