You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215935


✉ Email this page to a colleague

« Back to Dashboard


NDA 215935 describes TARPEYO, which is a drug marketed by Calliditas 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 TARPEYO profile page.

The generic ingredient in TARPEYO is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 215935
Tradename:TARPEYO
Applicant:Calliditas
Ingredient:budesonide
Patents:2
Pharmacology for NDA: 215935
Medical Subject Heading (MeSH) Categories for 215935
Suppliers and Packaging for NDA: 215935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TARPEYO budesonide CAPSULE, DELAYED RELEASE;ORAL 215935 NDA Calliditas Therapeutics AB 81749-004 81749-004-01 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength4MG
Approval Date:Dec 15, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 15, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Dec 15, 2028
Regulatory Exclusivity Use:TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G
Regulatory Exclusivity Expiration:Dec 20, 2030
Regulatory Exclusivity Use:TO REDUCE THE LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON DECEMBER 15, 2021

Complete Access Available with Subscription

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.