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-three 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 18^th, 2008.

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Summary for ORTIKOS

International Patents:	3
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	6,337
What excipients (inactive ingredients) are in ORTIKOS?	ORTIKOS excipients list
DailyMed Link:	ORTIKOS at DailyMed

Drug patent expirations by year 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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON

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Glossary

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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	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-002	Jun 13, 2019		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-001	Jun 13, 2019		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Sun Pharm Inds Inc	ORTIKOS	budesonide	CAPSULE, DELAYED RELEASE;ORAL	211929-002	Jun 13, 2019		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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

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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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2018530535	ブデゾニドの経口医薬剤形	⤷ Subscribe
European Patent Office	3346996		⤷ Subscribe
World Intellectual Property Organization (WIPO)	2017042835		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ORTIKOS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	SPC/GB21/029	United Kingdom	⤷ Subscribe	PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024	2190014-7	Sweden	⤷ Subscribe	PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	21C1020	France	⤷ Subscribe	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	⤷ Subscribe	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ORTIKOS

Patents protecting ORTIKOS

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