DrugPatentWatch Database Preview
UTIBRON Drug Profile
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Which patents cover Utibron, and what generic alternatives are available?
This drug has three hundred and sixty-six patent family members in forty-three countries.
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
| International Patents: | 366 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for UTIBRON |
| DailyMed Link: | UTIBRON at DailyMed |
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 | ➤ 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 | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 |
Non-Orange Book US Patents for UTIBRON
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,541,022 | Pharmaceutical formulations for dry powder inhalers | ➤ Sign Up |
| 9,040,559 | BETA2-adrenoceptor agonists | ➤ Sign Up |
| 7,622,483 | .beta.2-adrenoceptor agonists | ➤ Sign Up |
| 7,368,104 | Treatment of respiratory diseases | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for UTIBRON
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Luxembourg | 92393 | ➤ Sign Up |
| United Kingdom | 0127359 | ➤ Sign Up |
| Hong Kong | 1045837 | ➤ Sign Up |
| New Zealand | 550625 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0583 | Netherlands | ➤ Sign Up | PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| C009/2010 | Ireland | ➤ Sign Up | SPC009/2010: 20100813, EXPIRES: 20241129 |
| 2013000029 | Germany | ➤ Sign Up | PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| 1267866/02 | Switzerland | ➤ Sign Up | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
