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Last Updated: March 28, 2024

ORTIKOS Drug Patent Profile


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When do Ortikos patents expire, and what generic alternatives are available?

Ortikos is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in ORTIKOS is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ortikos

A generic version of ORTIKOS was approved as budesonide by TEVA PHARMS on November 18th, 2008.

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US Patents and Regulatory Information for ORTIKOS

ORTIKOS is protected by two US patents.

Patents protecting ORTIKOS

Oral pharmaceutical dosage forms of budesonide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Oral pharmaceutical dosage forms of budesonide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-001 Jun 13, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-002 Jun 13, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-001 Jun 13, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ORTIKOS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Dr. Falk Pharma GmbH Jorveza budesonide EMEA/H/C/004655
Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Authorised no no yes 2018-01-08
Stada Arzneimittel AG Kinpeygo budesonide EMEA/H/C/005653
Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Authorised no no yes 2022-07-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for ORTIKOS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 301102 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 LUC00208 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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