➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Merck
McKesson
Johnson and Johnson
Mallinckrodt
Express Scripts

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211929


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 211929 describes ORTIKOS, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ORTIKOS profile page.

The generic ingredient in ORTIKOS is budesonide. There are twenty-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 211929
Tradename:ORTIKOS
Applicant:Sun Pharma Global
Ingredient:budesonide
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 211929
Medical Subject Heading (MeSH) Categories for 211929
Suppliers and Packaging for NDA: 211929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929 NDA Ferring Pharmaceuticals Inc. 55566-1002 55566-1002-1 30 CAPSULE in 1 BOTTLE (55566-1002-1)
ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929 NDA Ferring Pharmaceuticals Inc. 55566-1020 55566-1020-1 30 CAPSULE in 1 BOTTLE (55566-1020-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED 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:RXDosage:CAPSULE, EXTENDED 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Johnson and Johnson
McKesson
Baxter
Colorcon

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.