OMNARIS Drug Patent Profile

Name: OMNARIS Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Omnaris, and when can generic versions of Omnaris launch?

Omnaris is a drug marketed by Azurity and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in OMNARIS is ciclesonide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciclesonide profile page.

DrugPatentWatch^® Generic Entry Outlook for Omnaris

Omnaris was eligible for patent challenges on October 20, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for OMNARIS

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	8
Patent Applications:	6,551
Drug Prices:	Drug price information for OMNARIS
What excipients (inactive ingredients) are in OMNARIS?	OMNARIS excipients list
DailyMed Link:	OMNARIS at DailyMed

Drug patent expirations by year for OMNARIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMNARIS

Generic Entry Date for OMNARIS^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial NDA: 022004 Dosage: SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OMNARIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 2/Phase 3
Takeda	Phase 3
AstraZeneca	Phase 3

See all OMNARIS clinical trials

Paragraph IV (Patent) Challenges for OMNARIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMNARIS	Nasal Spray	ciclesonide	50 mcg	022004	1	2012-02-13

US Patents and Regulatory Information for OMNARIS

OMNARIS is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMNARIS is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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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
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OMNARIS

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Start Trial	⤷ Start Trial
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Start Trial	⤷ Start Trial
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Start Trial	⤷ Start Trial
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Start Trial	⤷ Start Trial
Azurity	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for OMNARIS

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim Vetmedica GmbH	Aservo EquiHaler	ciclesonide	EMEA/V/C/004991For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction – (RAO), Summer Pasture Associated Recurrent Airway Obstruction – (SPA-RAO)).	Authorised	no	no	no	2020-01-28
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for OMNARIS

See the table below for patents covering OMNARIS around the world.

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Country	Patent Number	Title	Estimated Expiration
Portugal	1225902		⤷ Start Trial
Denmark	0998916		⤷ Start Trial
Switzerland	683343	1,4-Pregnadien-3,20-dion-16,17-acetal-21-ester, Verfahren zu ihrer Herstellung und pharmazeutische Präparate, die sie enthalten.	⤷ Start Trial
Hong Kong	1050858		⤷ Start Trial
Norway	327379		⤷ Start Trial
Guatemala	199900180A	COMPOSICION FARMACÉUTICA PARA SER APLICADA A LAS MUCOSAS .	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration