ZETONNA Drug Patent Profile
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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.
DrugPatentWatch® 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
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Summary for ZETONNA
| International Patents: | 14 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 66 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,217 |
| Drug Prices: | Drug price information for ZETONNA |
| What excipients (inactive ingredients) are in ZETONNA? | ZETONNA excipients list |
| DailyMed Link: | ZETONNA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
ZETONNA is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZETONNA is ⤷ Subscribe.
This potential generic entry date is based on patent 8,371,292.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZETONNA
Use of ciclesonide for the treatment of respiratory diseases
Patent Number: 8,371,292
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR TREATING A RESPIRATORY DISEASE IN A CHILD
| 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 | DISCN | Yes | No | 8,371,292 | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 | 6,120,752 | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | 5,482,934 | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | 6,264,923 | ⤷ Subscribe |
| Covis | ZETONNA | ciclesonide | AEROSOL, METERED;NASAL | 202129-001 | Jan 20, 2012 | 6,036,942 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ZETONNA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim Vetmedica GmbH | Aservo EquiHaler | ciclesonide | EMEA/V/C/004991 For 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 ZETONNA
See the table below for patents covering ZETONNA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2077971 | ⤷ Subscribe | |
| European Patent Office | 0995434 | ⤷ Subscribe | |
| New Zealand | 241170 | DEVICE FOR DELIVERING AN AEROSOL HAVING A VALVE STEM PASSING THROUGH A DIAPHRAGM COMPRISING A BLEND OF THERMOPLASTIC ELASTOMER WHICH IS MORE THAN 80% ETHYLENE POLYMER BLENDS, SEALS PREPARED THEREFROM | ⤷ Subscribe |
| Germany | 69406916 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZETONNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0983058 | CA 2005 00036 | Denmark | ⤷ Subscribe | |
| 0983058 | PA2005006,C0983058 | Lithuania | ⤷ Subscribe | 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 | Lithuania | ⤷ Subscribe | 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 | SPC022/2005 | Ireland | ⤷ Subscribe | SPC022/2005, 20060612, EXPIRES: 20190415 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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