Olodaterol hydrochloride - Generic Drug Details
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What are the generic sources for olodaterol hydrochloride and what is the scope of patent protection?
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 |
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 | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108-001 | Jul 31, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for olodaterol hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | PA05002162 | DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE. (BLOCKING DEVICE FOR A SPRUNG LOCK WITH A SPRING OPERATION.) | ⤷ Try a Trial |
| China | 100496759 | ⤷ Try a Trial | |
| Russian Federation | 2337765 | БЛОКИРОВОЧНОЕ ПРИСПОСОБЛЕНИЕ ДЛЯ СТОПОРНО-ЗАЖИМНОГО МЕХАНИЗМА С ВЫХОДНЫМ ЗВЕНОМ С ПРУЖИННЫМ ПРИВОДОМ (BLOCKING UNIT FOR LOCK CLAMPING DEVICE WITH SPRING-DRIVEN OUTPUT LINK) | ⤷ Try a Trial |
| Slovenia | 1789405 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for olodaterol hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1562603 | C300650 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION: |
| 1562603 | 21/2014 | Austria | ⤷ Try a Trial | 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 | PA2014012,C1562603 | Lithuania | ⤷ Try a Trial | PRODUCT 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 |
| 1562603 | 122014000018 | Germany | ⤷ Try a Trial | 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 |
| >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.
ISSN: 2162-2639
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