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STIOLTO RESPIMAT Drug Profile

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Which patents cover Stiolto Respimat, and what substitute generic drugs are available?

Stiolto Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are twenty-five patents protecting this drug.

This drug has five hundred and forty-eight patent family members in fifty-one countries.

The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride; tiotropium bromide profile page.

Summary for Tradename: STIOLTO RESPIMAT

Patents:25
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list4
Drug Prices:see details
DailyMed Link:STIOLTO RESPIMAT at DailyMed

Pharmacology for Tradename: STIOLTO RESPIMAT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYesRE39820► SubscribeYY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes9,027,967► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,396,341► SubscribeY ► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015RXYesYes7,988,001► SubscribeY ► Subscribe
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Expired Patents for Tradename: STIOLTO RESPIMAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,176,442► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,246,615► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20157,104,470► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,149,054► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 20156,726,124► Subscribe
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Non-Orange Book Patents for Tradename: STIOLTO RESPIMAT

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
6,402,055 Device for producing high pressure in a fluid in miniature► Subscribe
5,610,163 Esters of thienyl carboxylic acids and amino alcohols and their quaternization products► Subscribe
6,503,440 Process for making a container with a pressure equalization opening and containers produced accordingly► Subscribe
7,645,383Microstructured filter► Subscribe
6,497,373 Device for producing high pressure in a fluid in miniature► 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: STIOLTO RESPIMAT

Country Document Number Estimated Expiration
Israel140221► Subscribe
EcuadorSP055774► Subscribe
Uruguay26021► Subscribe
Norway320177► Subscribe
Brazil0008423► 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: STIOLTO RESPIMAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90016-1Sweden► SubscribePRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
2014012Lithuania► SubscribePRODUCT NAME: OLODATEROLUM; REGISTRATION NO/DATE: LT/1/13/3429/001 LT/1/13/3429/003 LT/1/13/3429/003 LT/1/13/3429/004 20131031
00084Netherlands► SubscribePRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
2014012,C1562603Lithuania► SubscribePRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: MA211/00401 20130918
C/GB02/036United Kingdom► SubscribePRODUCT NAME: SCOPINE DI-(2-THIENYL)GLYCOLATE IN THE FORM OF THE QUATERNARY SALTS - ESPECIALLY SALTS OF TIOTROPIUM - PREFERRED TIOTROPIUMBROMIDE AND TIOTROPIUMBROMIDE MONOHYDRATE; REGISTERED: NL RVG26191 20011009; UK PL14598/0062 20020514
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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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