DrugPatentWatch Database Preview
ZETONNA Drug Profile
» See Plans and Pricing
Which patents cover Zetonna, and what generic alternatives are available?
Zetonna is a drug marketed by Covis and is included in one NDA. There is one patent protecting this drug.
This drug has fourteen patent family members in twelve countries.
The generic ingredient in ZETONNA 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 Zetonna
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.
Indicators of Generic Entry
Summary for ZETONNA
| International Patents: | 14 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,907 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZETONNA |
| DailyMed Link: | ZETONNA at DailyMed |
Generic Entry Opportunity Date for ZETONNA
Generic Entry Date for ZETONNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, 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 ZETONNA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sunovion | Phase 4 |
US Patents and Regulatory Information for ZETONNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | 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 ZETONNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | Start Trial | Start Trial |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | Start Trial | Start Trial |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | Start Trial | Start Trial |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZETONNA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69701051 | Start Trial |
| Norway | 327716 | Start Trial |
| Germany | 69128157 | Start Trial |
| United Kingdom | 9803990 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZETONNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0983058 | SPC022/2005 | Ireland | Start Trial | SPC022/2005, 20060612, EXPIRES: 20190415 |
| 0983058 | CA 2005 00036 | Denmark | Start Trial | |
| 0983058 | PA2005006 | Lithuania | Start Trial | PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321 |
| 0983058 | PA2005006,C0983058 | Lithuania | Start Trial | PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
