Olodaterol hydrochloride - Generic Drug Details
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What are the generic drug sources for olodaterol hydrochloride and what is the scope of freedom to operate?
Olodaterol hydrochloride
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Olodaterol hydrochloride has one hundred and ninety-four patent family members in forty countries.
One supplier is listed for this compound.
Summary for olodaterol hydrochloride
International Patents: | 194 |
US Patents: | 12 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 40 |
Patent Applications: | 103 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for olodaterol hydrochloride |
DailyMed Link: | olodaterol hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for olodaterol hydrochloride
Generic Entry Date for olodaterol hydrochloride*:
Constraining patent/regulatory exclusivity:
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 olodaterol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boehringer Ingelheim | N/A |
Yonsei University | N/A |
Fraunhofer-Institute of Toxicology and Experimental Medicine | Phase 4 |
Pharmacology for olodaterol hydrochloride
Drug Class | beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for olodaterol hydrochloride
US Patents and Regulatory Information for olodaterol hydrochloride
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 | 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 | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for olodaterol hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Croatia | P20050432 | NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES | ⤷ Sign Up |
Hong Kong | 1093175 | MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION, SPRAYER WITH THE NOZZLE AND MANUFACTURING METHOD OF THE NOZZLE | ⤷ Sign Up |
New Zealand | 540661 | Novel medicaments for the treatment of chronic obstructive pulmonary diseases | ⤷ Sign Up |
China | 1809424 | Microstructured high-pressure nozzle with integrated filter function | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for olodaterol hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1562603 | 300650 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OLODATEROL, HET R-ENANTIOMEER DAARVAN, MENGSELS VAN ISOMEREN DAARVAN, ZUURADDITIEZOUTEN MET FARMACOLOGISCH AANVAARDBARE ZUREN DAARVAN, EVENALS SOLVATEN EN/OF HYDRATEN DAARVAN, IN HET BIJZONDER OLODATEROL EN OLODATEROLHYDROCHLORIDE; REGISTRATION NO/DATE: RVG 112058 20131023 |
1562603 | 21/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: OLODATEROL, DESSEN SAEUREHAELTIGEN SALZE MIT PHARMAKOLOGISCH VERTRAEGLICHEN SAEUREN, IM BESONDEREN OLODATEROL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 135232 20131125; FIRST REGISTRATION: MT MA211/00401 20130918 |
1562603 | 122014000018 | Germany | ⤷ Sign Up | PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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