Stiolto Respimat Patent Expiration

Stiolto Respimat is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 34 US drug patents filed from 2015 to 2017. Out of these, 12 drug patents are active and 22 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 16, 2030. Details of Stiolto Respimat's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE39820 Esters of thienyl carboxylic acids and amino alcohols and their quaternization products
Jan, 2018

(6 years ago)

Expired
US7491719 Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments
Nov, 2023

(8 months ago)

Expired
US7056916 Medicaments for the treatment of chronic obstructive pulmonary disease
Dec, 2023

(7 months ago)

Expired
US7220742 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
May, 2025

(9 months from now)

Active
US7727984 Medicaments for the treatment of chronic obstructive pulmonary disease
Jan, 2027

(2 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7246615 Atomising nozzle and filter and spray generating device
May, 2016

(8 years ago)

Expired
US5964416 Device for producing high pressure in a fluid in miniature
Oct, 2016

(7 years ago)

Expired
US6726124 Device for producing high pressure in a fluid in miniature
Oct, 2016

(7 years ago)

Expired
US6176442 Device for mounting a component exposed to a pressurized fluid
Oct, 2016

(7 years ago)

Expired
US7104470 Device for producing high pressure in a fluid in miniature
Oct, 2016

(7 years ago)

Expired
US6453795 Locking mechanism for a spring-actuated device
Dec, 2016

(7 years ago)

Expired
US6149054 Mechanical counter for a metering apparatus
Dec, 2016

(7 years ago)

Expired
US6149054

(Pediatric)

Mechanical counter for a metering apparatus
Jun, 2017

(7 years ago)

Expired
US6977042 Microstructured filter
Aug, 2018

(5 years ago)

Expired
US6846413 Microstructured filter
Aug, 2018

(5 years ago)

Expired
US7802568 Cartridge for a liquid
Feb, 2019

(5 years ago)

Expired
US6977042

(Pediatric)

Microstructured filter
Feb, 2019

(5 years ago)

Expired
US6846413

(Pediatric)

Microstructured filter
Feb, 2019

(5 years ago)

Expired
US7802568

(Pediatric)

Cartridge for a liquid
Aug, 2019

(4 years ago)

Expired
US6988496 Cartridge for a liquid
Feb, 2020

(4 years ago)

Expired
US6988496

(Pediatric)

Cartridge for a liquid
Aug, 2020

(3 years ago)

Expired
US7988001 Container provided with a pressure equalization opening
Aug, 2021

(2 years ago)

Expired
US8044046 Medicaments for the treatment of chronic obstructive pulmonary disease
Nov, 2023

(8 months ago)

Expired
US7786111 Medicaments for the treatment of chronic obstructive pulmonary disease
Nov, 2023

(8 months ago)

Expired
US7284474 Piston-pumping system having o-ring seal properties
Aug, 2024

(29 days from now)

Active
US7284474

(Pediatric)

Piston-pumping system having o-ring seal properties
Feb, 2025

(6 months from now)

Active
US8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments
May, 2025

(9 months from now)

Active
US7896264 Microstructured high pressure nozzle with built-in filter function
May, 2025

(9 months from now)

Active
US7396341 Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Oct, 2026

(2 years from now)

Active
US9027967 Device for clamping a fluidic component
Mar, 2027

(2 years from now)

Active
US7396341

(Pediatric)

Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Apr, 2027

(2 years from now)

Active
US7837235 Device for clamping a fluidic component
Mar, 2028

(3 years from now)

Active
US7837235

(Pediatric)

Device for clamping a fluidic component
Sep, 2028

(4 years from now)

Active
US8733341 Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Oct, 2030

(6 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Stiolto Respimat's patents.

Given below is the list of recent legal activities going on the following patents of Stiolto Respimat.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 19 Apr, 2023 US8044046
Payment of Maintenance Fee, 12th Year, Large Entity 03 Apr, 2023 US8034809
Payment of Maintenance Fee, 12th Year, Large Entity 23 Feb, 2022 US7786111
Payment of Maintenance Fee, 12th Year, Large Entity 24 Nov, 2021 US7727984
Payment of Maintenance Fee, 12th Year, Large Entity 11 Aug, 2020 US7491719
Patent Term Extension Certificate 16 Dec, 2019 US7727984
Payment of Maintenance Fee, 8th Year, Large Entity 16 Apr, 2019 US8044046
Payment of Maintenance Fee, 8th Year, Large Entity 02 Apr, 2019 US8034809
Notice of Final Determination -Eligible 02 Apr, 2019 US7727984
Payment of Maintenance Fee, 12th Year, Large Entity 14 Nov, 2018 US7220742


FDA has granted several exclusivities to Stiolto Respimat. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Stiolto Respimat, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Stiolto Respimat.

Exclusivity Information

Stiolto Respimat holds 4 exclusivities. All of its exclusivities have expired in 2021. Details of Stiolto Respimat's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) May 21, 2018
M(M-173) Mar 18, 2019
New Chemical Entity Exclusivity(NCE) Jul 31, 2019
M(M-233) Oct 05, 2021

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Several oppositions have been filed on Stiolto Respimat's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Stiolto Respimat's generic, the next section provides detailed information on ongoing and past EP oppositions related to Stiolto Respimat patents.

Stiolto Respimat's oppositions filed in EPO

Stiolto Respimat has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 12, 2012, by Knorr-Bremse Systeme Für Nutzfahrzeuge Gmbh. This opposition was filed on patent number EP2004006768W. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP05737938A Apr, 2014 Aechter, Bernd Opposition rejected
EP2004006768W Apr, 2012 Knorr-Bremse Systeme für Nutzfahrzeuge GmbH Revoked


US patents provide insights into the exclusivity only within the United States, but Stiolto Respimat is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Stiolto Respimat's family patents as well as insights into ongoing legal events on those patents.

Stiolto Respimat's family patents

Stiolto Respimat has patent protection in a total of 42 countries. It's US patent count contributes only to 10.3% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Stiolto Respimat.

Family Patents

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Generic Launch

Generic Release Date:

Stiolto Respimat's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 16, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Stiolto Respimat Generics:

There are no approved generic versions for Stiolto Respimat as of now.





About Stiolto Respimat

Stiolto Respimat is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for managing symptoms of chronic obstructive pulmonary disease (COPD) and treating respiratory complaints. Stiolto Respimat uses Olodaterol Hydrochloride; Tiotropium Bromide as an active ingredient. Stiolto Respimat was launched by Boehringer Ingelheim in 2015.

Market Authorisation Date:

Stiolto Respimat was approved by FDA for market use on 21 May, 2015.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Stiolto Respimat is 21 May, 2015, its NCE-1 date is estimated to be 31 July, 2018

Active Ingredient:

Stiolto Respimat uses Olodaterol Hydrochloride; Tiotropium Bromide as the active ingredient. Check out other Drugs and Companies using Olodaterol Hydrochloride; Tiotropium Bromide ingredient

Treatment:

Stiolto Respimat is used for managing symptoms of chronic obstructive pulmonary disease (COPD) and treating respiratory complaints.

Dosage:

Stiolto Respimat is available in spray, metered form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH SPRAY, METERED Prescription INHALATION