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Last Updated: November 24, 2020

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STIOLTO RESPIMAT Drug Profile

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Which patents cover Stiolto Respimat, and when can generic versions of Stiolto Respimat launch?

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

This drug has two hundred and ninety-five patent family members in forty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Stiolto Respimat

Stiolto Respimat was eligible for patent challenges on July 31, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for STIOLTO RESPIMAT
Drug patent expirations by year for STIOLTO RESPIMAT
Drug Prices for STIOLTO RESPIMAT

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Generic Entry Opportunity Date for STIOLTO RESPIMAT
Generic Entry Date for STIOLTO RESPIMAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPRAY, METERED;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 Clinical Trials for STIOLTO RESPIMAT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
HealthcorePhase 4
Boehringer IngelheimPhase 4
Los Angeles Biomedical Research InstitutePhase 4

See all STIOLTO RESPIMAT clinical trials

Pharmacology for STIOLTO RESPIMAT

US Patents and Regulatory Information for STIOLTO RESPIMAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756-001 May 21, 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 STIOLTO RESPIMAT

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1562603 513 Finland   Start Trial
1562603 SPC/GB14/023 United Kingdom   Start Trial PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010
0418716 300084 Netherlands   Start Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
1562603 14C0049 France   Start Trial PRODUCT NAME: OLODATEROL, SES ISOMERES OPTIQUES INDIVIDUELS, MELANGES D'ENANTIOMERES INDIVIDUELS OU RACEMATE, SES SELS D'ADDITION D'ACIDE AVEC DES ACIDES PHARMACOLOGIQUEMENT ACCEPTABLES, AINSI QUE DES SOLVATES ET OU HYDRATES, EN PARTICULIER OLODATEROL OU CHLORHYDRATE D'OLODATEROL; NAT. REGISTRATION NO/DATE: NL42395 20140522; FIRST REGISTRATION: MT - MA211/00401 20130918
1562603 2014/016 Ireland   Start Trial PRODUCT NAME: OLODATEROL, OPTICAL ISOMERS THEREOF, MIXTURES OF ISOMERS THEREOF, ACID ADDITION SALTS THEREOF WITH PHARMACOLOGICALLY ACCEPTABLE ACIDS, AS WELL AS SOLVATES AND/OR HYDRATES THEREOF, IN PARTICULAR OLODATEROL AND OLODATEROL HYDROCHLORIDE.; NAT REGISTRATION NO/DATE: PA0775/006/001 20131018; FIRST REGISTRATION NO/DATE: MA211/00401 20130918
1562603 C300650 Netherlands   Start Trial PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION:
0418716 0290010-8 Sweden   Start Trial PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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