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OMNARIS Drug Profile
» See Plans and Pricing
Which patents cover Omnaris, and when can generic versions of Omnaris launch?
Omnaris is a drug marketed by Covis and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and seven patent family members in thirty-six 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.
US ANDA Litigation and Generic Entry Outlook for Omnaris
Omnaris was eligible for patent challenges on October 20, 2010.
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
Summary for OMNARIS
| International Patents: | 107 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 7 |
| Patent Applications: | 3,906 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OMNARIS |
| What excipients (inactive ingredients) are in OMNARIS? | OMNARIS excipients list |
| DailyMed Link: | OMNARIS at DailyMed |
Recent Clinical Trials for OMNARIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 3 |
| Sunovion | Phase 4 |
| West Penn Allegheny Health System | Phase 4 |
Paragraph IV (Patent) Challenges for OMNARIS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OMNARIS | SPRAY, METERED;NASAL | ciclesonide | 022004 | 2012-02-13 |
US Patents and Regulatory Information for OMNARIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | Start Trial | Start Trial |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | Start Trial | Start Trial |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | Start Trial | Start Trial |
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004-001 | Oct 20, 2006 | Start Trial | Start Trial |
| Covis | 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 |
International Patents for OMNARIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Netherlands | 194917 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0128563 | Start Trial |
| Hong Kong | 1050858 | Start Trial |
| Australia | 7953100 | Start Trial |
| Austria | 285779 | Start Trial |
| France | 2666585 | Start Trial |
| Slovakia | 6922002 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
