DrugPatentWatch Database Preview
UTIBRON Drug Profile
Which patents cover Utibron, and what generic alternatives are available?
Utibron is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are eighteen patents protecting this drug.
This drug has three hundred and seventy-four 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. One supplier is listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.
Summary for UTIBRON
| International Patents: | 374 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| 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 |
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.
Recent Litigation for UTIBRON
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Vectura Limited v. GlaxoSmithKline LLC | 2016-07-27 |
| Novartis AG v. Lee | 2013-01-14 |
| NOVARTIS AG v. KAPPOS | 2010-07-06 |
Pharmacology for UTIBRON
| Drug Class | beta2-Adrenergic Agonist Anticholinergic |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Synonyms for UTIBRON
| 1262431-94-6 |
| DTXSID60155126 |
| Glycopyrrolate / indacaterol |
| Glycopyrrolate mixture with indacaterol |
| Glycopyrronium bromide / indacaterol |
| Indacaterol / glycopyrrolate |
| Indacaterol / glycopyrronium |
| QVA 149 |
| QVA149 |
| Ultibro Breezhaler |
| Utibron Neohaler |
US Patents and Regulatory Information for UTIBRON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for UTIBRON
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 3785365 | Start Trial |
| Spain | 2587135 | Start Trial |
| Canada | 2522231 | Start Trial |
| Germany | 60140268 | Start Trial |
| South Africa | 200210225 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 122014000025 | Germany | Start Trial | 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 |
| 1183240 | 7/2010 | Austria | Start Trial | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| 1183240 | C01183240/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
| 1183240 | 91651 | Luxembourg | Start Trial | 91651, EXPIRES: 20241130 |
| 1267866 | 122013000029 | Germany | Start Trial | PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
