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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
McKesson
Teva
Fish and Richardson
Colorcon
Covington

Generated: November 20, 2018

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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.

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.

Drug patent expirations by year for UTIBRON
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.

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

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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

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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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
McKesson
Teva
Fish and Richardson
Colorcon
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.