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.
The generic ingredient in UTIBRON is glycopyrrolate ; indacaterol maleate. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.
Summary for UTIBRON
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| 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
*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.
Pharmacology for UTIBRON
| Drug Class | beta2-Adrenergic Agonist Anticholinergic |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ 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 |
|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | UTIBRON | glycopyrrolate ; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ➤ Sign Up | ➤ Sign Up |
| Sunovion Pharms Inc | 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
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Jordan | 2430 | ➤ Sign Up |
| Spain | 2369923 | ➤ Sign Up |
| Israel | 151791 | ➤ Sign Up |
| Denmark | 1920763 | ➤ Sign Up |
| Spain | 2402535 | ➤ Sign Up |
| New Zealand | 543026 | ➤ Sign Up |
| Hungary | 0300490 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 3 | Finland | ➤ Sign Up | |
| C0006 | France | ➤ Sign Up | PRODUCT NAME: INDACATEROL OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/09/593/001 DU 20091130; REGISTRATION NO/DATE AT EEC: EU/1/09/593/001-010 DU 20091130 |
| 2014000025 | Germany | ➤ Sign Up | 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 |
| 393 | 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 |
| 651 | Luxembourg | ➤ Sign Up | 91651, EXPIRES: 20241130 |
| 2013 00015 | Denmark | ➤ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003 |
| 1267866/02 | Switzerland | ➤ Sign Up | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
