DrugPatentWatch Database Preview
UTIBRON Drug Profile
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Which patents cover Utibron, and what generic alternatives are available?
Utibron is a drug marketed by Novartis and is included in one NDA. There are eighteen patents protecting this drug.
This drug has three hundred and seventy-eight 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 two 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: | 378 |
| 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.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | DISCN | Yes | No | 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 |
|---|---|---|---|---|---|---|---|
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | Start Trial | Start Trial |
| Novartis | 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0243700 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0243702 | Start Trial |
| Portugal | 1920763 | Start Trial |
| European Patent Office | 0725624 | Start Trial |
| European Patent Office | 1276473 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UTIBRON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1267866 | 2014C/022 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME) |
| 1267866 | 479 | Finland | Start Trial | |
| 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 | C300651 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919 |
| 1267866 | 2013/014 | Ireland | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
