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UTIBRON Drug Profile
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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-five 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.
US ANDA Litigation and 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 four 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: | 375 |
| 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 | |||
| 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 |
|---|---|---|
| European Patent Office | 1747036 | Start Trial |
| Spain | 2331457 | Start Trial |
| Australia | 2211802 | Start Trial |
| European Patent Office | 3269360 | Start Trial |
| United Kingdom | 0321612 | Start Trial |
| China | 1438875 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1183240 | 7/2010 | Austria | Start Trial | PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130 |
| 1267866 | 122013000029 | Germany | Start Trial | PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| 1267866 | CA 2013 00015 | Denmark | Start Trial | |
| 1267866 | C01267866/02 | Switzerland | Start Trial | FORMER OWNER: SOSEI R&D LTD., GB |
| 1267866 | 493 | Finland | Start Trial | |
| 1267866 | SPC/GB13/020 | United Kingdom | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
