UTIBRON Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for UTIBRON?
- What are the global sales for UTIBRON?
- What is Average Wholesale Price for UTIBRON?
Summary for UTIBRON
International Patents: | 148 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Patent Applications: | 11 |
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.
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
International Patents for UTIBRON
See the table below for patents covering UTIBRON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 0110301 | ⤷ Sign Up | |
Hong Kong | 1154584 | ⤷ Sign Up | |
Australia | 2002222115 | ⤷ Sign Up | |
Norway | 324037 | ⤷ Sign Up | |
Spain | 2292598 | ⤷ Sign Up | |
European Patent Office | 0806938 | POUDRE A UTILISER DANS DES INHALATEURS A POUDRE SECHE (POWDER FOR USE IN DRY POWDER INHALERS) | ⤷ Sign Up |
Spain | 2288167 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1267866 | 479 | Finland | ⤷ Sign Up | |
1183240 | C 2010 011 | Romania | ⤷ Sign Up | PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...] |
1183240 | C01183240/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
1267866 | 132013902141564 | Italy | ⤷ Sign Up | PRODUCT NAME: GLICOPIRRONIO BROMURO(SEEBRI BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/788/001-006, 20120928 |
1267866 | C300583 | Netherlands | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
1267866 | CA 2013 00015 | Denmark | ⤷ Sign Up | |
1267866 | 132014902244065 | Italy | ⤷ Sign Up | PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |