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Serving leading biopharmaceutical companies globally:

Teva
Accenture
Harvard Business School
Cipla
McKesson
AstraZeneca
Daiichi Sankyo
Cerilliant
Boehringer Ingelheim
Julphar

Generated: December 16, 2017

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 Sunovion Pharms Inc and is included in one NDA. There are sixteen patents protecting this drug.

This drug has three hundred and sixty patent family members in forty-three countries and twenty-four supplementary protection certificates in ten 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: 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
7,541,022Pharmaceutical formulations for dry powder inhalers► Subscribe
9,585,839Particles for use in a pharmaceutical composition► Subscribe
8,932,635Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation► Subscribe
7,622,483.beta.2-adrenoceptor agonists► Subscribe
7,744,855Method of making particles for use in a pharmaceutical composition► Subscribe
9,351,928Method of making particles for use in a pharmaceutical composition► Subscribe
8,101,160Formulations for use in inhaler devices► Subscribe
7,368,104Treatment of respiratory diseases► Subscribe
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► Subscribe
8,182,791Formulations for use in inhaler devices► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: UTIBRON

Country Document Number Estimated Expiration
South Africa200608728► Subscribe
World Intellectual Property Organization (WIPO)2005025536► Subscribe
Australia4858101► Subscribe
World Intellectual Property Organization (WIPO)0178696► Subscribe
Israel151791► Subscribe
World Intellectual Property Organization (WIPO)0243702► Subscribe
Portugal1183240► Subscribe
Poland198847► Subscribe
Australia2004231342► Subscribe
Portugal2332915► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: UTIBRON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3Finland► Subscribe
7/2010Austria► SubscribePRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240/01Switzerland► SubscribePRODUCT NAME: INDACATEROL; REGISTRATION NO/DATE: SWISSMEDIC 60141 21.05.2010
C/GB10/009United Kingdom► SubscribePRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
00583Netherlands► SubscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
C0006France► SubscribePRODUCT 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
2010 00006Denmark► Subscribe
2013 00015Denmark► Subscribe
651Luxembourg► Subscribe91651, EXPIRES: 20241130
1267866/02Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Argus Health
Mallinckrodt
Teva
Boehringer Ingelheim
Dow
Baxter
AstraZeneca
Johnson and Johnson

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.

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