OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - Generic Drug Details
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What are the generic drug sources for olodaterol hydrochloride; tiotropium bromide and what is the scope of patent protection?
Olodaterol hydrochloride; tiotropium bromide
is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Olodaterol hydrochloride; tiotropium bromide has one hundred and ninety-four patent family members in forty countries.
One supplier is listed for this compound.
Summary for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| International Patents: | 194 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE |
| DailyMed Link: | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
*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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| Drug Class | Anticholinergic beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Paragraph IV (Patent) Challenges for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| STIOLTO RESPIMAT | Inhalation Spray | olodaterol hydrochloride; tiotropium bromide | 2.5 mcg/2.5 mcg per spray | 206756 | 1 | 2024-05-24 |
US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2552535 | DISPOSITIF POUR FIXER UN COMPOSANT FLUIDIQUE (DEVICE FOR HOLDING A FLUIDIC COMPONENT) | ⤷ Sign Up |
| South Korea | 20060134060 | DEVICE FOR HOLDING A FLUIDIC COMPONENT | ⤷ Sign Up |
| European Patent Office | 2025338 | Nouveaux medicaments pour le traitement de la bronchopneumopathie obstructive chronique (New medicaments for the treatment of chronic ostructive pulmonary disease) | ⤷ Sign Up |
| Germany | 502007005273 | ⤷ Sign Up | |
| Germany | 50313314 | ⤷ Sign Up | |
| Brazil | 0316264 | Medicamento para tratamento de doença pulmonar obstrutiva crÈnica | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1562603 | 132014902316088 | Italy | ⤷ Sign Up | PRODUCT NAME: OLODATEROLO, SUOI SINGOLI ISOMERI OTTICI, MISCELE DEI SINGOLI ENANTIOMERI O DI RACEMATI, SUOI SALI DI ADDIZIONE CON ACIDI FARMACOLOGICAMENTE ACCETTABILI NONCHE' SUOI SOLVATI E/O IDRATI, IN PARTICOLARE OLODATEROLO E OLODATEROLO CLORIDRATO(STRIVERDI RESPIMAT); AUTHORISATION NUMBER(S) AND DATE(S): MA211/00401, 20130918;042432017-029-031-043, 20140618 |
| 1562603 | 159 5009-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918 |
| 1562603 | PA2014012 | Lithuania | ⤷ Sign Up | PRODUCT 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 |
| 1562603 | C 2014 025 | Romania | ⤷ Sign Up | PRODUCT NAME: OLODATEROL, IZOMERI OPTICI INDIVIDUALI AI ACESTUIA,AMESTECURI DE ENANTIOMERI INDIVIDUALI SAU RACEMATI, SARURILE DE ADITIE ACIDA ALE ACESTORA CU ACIZI ACCEPTABILIFARMACOLOGIC, CA SI SOLVATI SI/SAU HIDRATI AI ACESTORA, IN SPECIAL OLODATEROL SI CLORHI DRAT DE OLODATEROL -6-HIDROXI-2-{[1-(4-METOXIFENIL)-1,1-DIMETILETIL]AMINO}ETIL]-2H-1,4-BENZOXAZIN-3(4H)-ONA(CACLORHIDRAT); NATIONAL AUTHORISATION NUMBER: 6414/2014/01, 6414/2014/02, 6414/2014/03, 6414/2014/04; DATE OF NATIONAL AUTHORISATION: 20140507; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MA211/00401; DATE OF FIRST AUTHORISATION IN EEA: 20130918 |
| 1562603 | 92433 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL |
| 1562603 | 14C0049 | France | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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DrugPatentWatch Alternatives
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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