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: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| 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 | ||||
| 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 |
|---|---|---|
| 8,932,635 | Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation | ➤ Sign Up |
| 7,223,748 | Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets | ➤ Sign Up |
| 7,368,104 | Treatment of respiratory diseases | ➤ Sign Up |
| 7,622,483 | .beta.2-adrenoceptor agonists | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for UTIBRON
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Czech Republic | 20023437 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004093848 | ➤ Sign Up |
| Slovakia | 17432001 | ➤ Sign Up |
| European Patent Office | 1747036 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2010 00006 | Denmark | ➤ Sign Up | PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT |
| 2013 00015 | Denmark | ➤ Sign Up | |
| 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 |
| 1183240/01 | Switzerland | ➤ Sign Up | FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
