UTIBRON Drug Patent Profile
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When do Utibron patents expire, 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: | 4 |
Patent Applications: | 11 |
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 Loss of Exclusivity (LOE) Date for UTIBRON
Generic Entry Date for UTIBRON*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION |
*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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a 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.
Patents protecting UTIBRON
Beta2-adrenoceptor agonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Inhaler device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Australia
Patent: 05245095
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 02666
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0511073
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 63573
Estimated Expiration: ⤷ Try a Trial
China
Patent: 53779
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 11555
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 47036
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 066987
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 47036
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2005027064
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 02919
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8878
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 14345
Estimated Expiration: ⤷ Try a Trial
Patent: 07536962
Estimated Expiration: ⤷ Try a Trial
Patent: 12071146
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4563
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06013081
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 612
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0625
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 4854
Estimated Expiration: ⤷ Try a Trial
Patent: 065718
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060098
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 47036
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 47036
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 63501
Estimated Expiration: ⤷ Try a Trial
Patent: 06143840
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 47036
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0608728
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1170187
Estimated Expiration: ⤷ Try a Trial
Patent: 070011466
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 62429
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 53857
Estimated Expiration: ⤷ Try a Trial
Patent: 0613021
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 06367
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 10712
Estimated Expiration: ⤷ Try a 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.
See the table below for additional patents covering UTIBRON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | 0300499 | ⤷ Try a Trial | |
China | 100551358 | ⤷ Try a Trial | |
Poland | 352100 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0178696 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1267866 | C300583 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
1183240 | 91651 | Luxembourg | ⤷ Try a Trial | 91651, EXPIRES: 20241130 |
1183240 | 7/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
1267866 | 2013/014 | Ireland | ⤷ Try a Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |