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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 thirteen patents protecting this drug.
This drug has three hundred and seventy-eight patent family members in forty-four 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: | 378 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| 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
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 thirteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of UTIBRON is ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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 it Free
Patent Expiration: ⤷ Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Treatment of respiratory disease
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Treatment of respiratory diseases
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Pharmaceutical compositions for inhalation
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Inhaler device
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Particles for use in a pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
| 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 it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >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 it Free | ⤷ Try it Free |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try it Free | ⤷ Try it Free |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try it Free | ⤷ Try it Free |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for UTIBRON
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H09507049 | ⤷ Try it Free |
| Portugal | 1666023 | ⤷ Try it Free |
| Canada | 2539041 | ⤷ Try it Free |
| Eurasian Patent Organization | 000352 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 122014000025 | Germany | ⤷ Try it Free | PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919 |
| 1267866 | 2013C/023 | Belgium | ⤷ Try it Free | PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002 |
| 1267866 | C300651 | Netherlands | ⤷ Try it Free | PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919 |
| 1183240 | SPC009/2010 | Ireland | ⤷ Try it Free | SPC009/2010: 20100813, EXPIRES: 20241129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
