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Last Updated: October 1, 2022

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. Thirty-eight 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-002 Jun 13, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-001 Jun 13, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-002 Jun 13, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 LUC00208 Luxembourg See Plans and Pricing 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
2435024 21C1020 France See Plans and Pricing 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
0613371 SPC/GB02/033 United Kingdom See Plans and Pricing PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024 132021000000095 Italy See Plans and Pricing PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024 2021C/518 Belgium See Plans and Pricing PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024 301102 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
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Baxter

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