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-four 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.
Summary for ORTIKOS
| International Patents: | 3 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Patent Applications: | 6,138 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ORTIKOS? | ORTIKOS excipients list |
| DailyMed Link: | ORTIKOS at DailyMed |
Pharmacology for ORTIKOS
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ORTIKOS
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 | RX | 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 | RX | Yes | Yes | ⤷ 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 | RX | 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 |
International Patents for ORTIKOS
See the table below for patents covering ORTIKOS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3346996 | ⤷ Try a Trial | |
| Japan | 2018530535 | ブデゾニドの経口医薬剤形 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2017042835 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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 | 132021000000095 | Italy | ⤷ Try a Trial | 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 |
| 0613371 | SPC/GB02/033 | United Kingdom | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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