UTIBRON Drug Patent Profile
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Which patents cover Utibron, and what generic alternatives are available?
Utibron is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and forty-eight patent family members in forty countries.
The generic ingredient in UTIBRON is glycopyrrolate; indacaterol maleate. There are seventeen drug master file entries for this compound. Additional details are available on the glycopyrrolate; indacaterol maleate profile page.
DrugPatentWatch® Generic Entry Outlook for Utibron
Utibron was eligible for patent challenges on July 1, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 11, 2028. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for UTIBRON
| International Patents: | 148 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Patent Applications: | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for UTIBRON |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for UTIBRON |
| DailyMed Link: | UTIBRON at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for UTIBRON
*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.
Anatomical Therapeutic Chemical (ATC) Classes for UTIBRON
US Patents and Regulatory Information for UTIBRON
UTIBRON is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of UTIBRON is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 UTIBRON
Beta2-adrenoceptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Inhaler device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 UTIBRON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for UTIBRON
When does loss-of-exclusivity occur for UTIBRON?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1353
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 05245095
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 2666
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0511073
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 63573
Estimated Expiration: ⤷ Sign Up
China
Patent: 53779
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 11555
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 47036
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 066987
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 47036
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2005027064
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 02919
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8878
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 14345
Estimated Expiration: ⤷ Sign Up
Patent: 07536962
Estimated Expiration: ⤷ Sign Up
Patent: 12071146
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4563
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 06013081
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 612
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0625
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 4854
Estimated Expiration: ⤷ Sign Up
Patent: 065718
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 060098
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 47036
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 47036
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 63501
Estimated Expiration: ⤷ Sign Up
Patent: 06143840
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 47036
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0608728
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1170187
Estimated Expiration: ⤷ Sign Up
Patent: 070011466
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 62429
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 53857
Estimated Expiration: ⤷ Sign Up
Patent: 0613021
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 06367
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 10712
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering UTIBRON around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2288167 | ⤷ Sign Up | |
| Japan | 2007505832 | ⤷ Sign Up | |
| Denmark | 1267866 | ⤷ Sign Up | |
| Mexico | 9705847 | PARTICULAS VEHICULOS PARA SU USO EN INHALADORES DE POLVO SECO. (CARRIER PARTICLES FOR USE IN DRY POWDER INHALERS.) | ⤷ Sign Up |
| Hungary | 229965 | Carrier particles for use in dry powder inhalers | ⤷ Sign Up |
| Slovenia | 1232745 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1183240 | SPC009/2010 | Ireland | ⤷ Sign Up | SPC009/2010: 20100813, EXPIRES: 20241129 |
| 1267866 | CA 2014 00020 | Denmark | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919 |
| 1183240 | 383 | Finland | ⤷ Sign Up | |
| 1267866 | 92393 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923 |
| 1183240 | CA 2010 00006 | Denmark | ⤷ Sign Up | PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT |
| 1183240 | 7/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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