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, 11 drug patents are active and 23 have expired. Stiolto Respimat's patents have been open to challenges since 31 July, 2018. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7727984 | Medicaments for the treatment of chronic obstructive pulmonary disease |
Jan, 2027
(2 years from now) | Active |
| US7220742 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
May, 2025
(5 months from now) | Active |
| US7056916 | Medicaments for the treatment of chronic obstructive pulmonary disease |
Dec, 2023
(11 months ago) |
Expired
|
| US7491719 | Enantiomerically pure beta agonists, process for the manufacture thereof, and use thereof as medicaments |
Nov, 2023
(1 year, 6 days ago) |
Expired
|
| USRE39820 | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
Jan, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8733341 | Atomizer and method of atomizing fluid with a nozzle rinsing mechanism |
Oct, 2030
(5 years from now) | Active |
|
US7837235 (Pediatric) | Device for clamping a fluidic component |
Sep, 2028
(3 years from now) | Active |
| US7837235 | Device for clamping a fluidic component |
Mar, 2028
(3 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 |
| US9027967 | Device for clamping a fluidic component |
Mar, 2027
(2 years from now) | Active |
| US7396341 | Blocking device for a locking stressing mechanism having a spring-actuated output drive device |
Oct, 2026
(1 year, 10 months from now) | Active |
| US7896264 | Microstructured high pressure nozzle with built-in filter function |
May, 2025
(6 months from now) | Active |
| US8034809 | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
May, 2025
(5 months from now) | Active |
|
US7284474 (Pediatric) | Piston-pumping system having o-ring seal properties |
Feb, 2025
(3 months from now) | Active |
| US7284474 | Piston-pumping system having o-ring seal properties |
Aug, 2024
(2 months ago) |
Expired
|
| US7786111 | Medicaments for the treatment of chronic obstructive pulmonary disease |
Nov, 2023
(1 year, 6 days ago) |
Expired
|
| US8044046 | Medicaments for the treatment of chronic obstructive pulmonary disease |
Nov, 2023
(1 year, 6 days ago) |
Expired
|
| US7988001 | Container provided with a pressure equalization opening |
Aug, 2021
(3 years ago) |
Expired
|
|
US6988496 (Pediatric) | Cartridge for a liquid |
Aug, 2020
(4 years ago) |
Expired
|
| US6988496 | Cartridge for a liquid |
Feb, 2020
(4 years ago) |
Expired
|
|
US7802568 (Pediatric) | Cartridge for a liquid |
Aug, 2019
(5 years ago) |
Expired
|
|
US6846413 (Pediatric) | Microstructured filter |
Feb, 2019
(5 years ago) |
Expired
|
|
US6977042 (Pediatric) | Microstructured filter |
Feb, 2019
(5 years ago) |
Expired
|
| US7802568 | Cartridge for a liquid |
Feb, 2019
(5 years ago) |
Expired
|
| US6846413 | Microstructured filter |
Aug, 2018
(6 years ago) |
Expired
|
| US6977042 | Microstructured filter |
Aug, 2018
(6 years ago) |
Expired
|
|
US6149054 (Pediatric) | Mechanical counter for a metering apparatus |
Jun, 2017
(7 years ago) |
Expired
|
| US6149054 | Mechanical counter for a metering apparatus |
Dec, 2016
(7 years ago) |
Expired
|
| US6453795 | Locking mechanism for a spring-actuated device |
Dec, 2016
(7 years ago) |
Expired
|
| US6176442 | Device for mounting a component exposed to a pressurized fluid |
Oct, 2016
(8 years ago) |
Expired
|
| US7104470 | Device for producing high pressure in a fluid in miniature |
Oct, 2016
(8 years ago) |
Expired
|
| US6726124 | Device for producing high pressure in a fluid in miniature |
Oct, 2016
(8 years ago) |
Expired
|
| US5964416 | Device for producing high pressure in a fluid in miniature |
Oct, 2016
(8 years ago) |
Expired
|
| US7246615 | Atomising nozzle and filter and spray generating device |
May, 2016
(8 years ago) |
Expired
|
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.
Latest Legal Activities on Stiolto Respimat's Patents
Given below is the list of recent legal activities going on the following patents of Stiolto Respimat.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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.
Approval Date:
Stiolto Respimat was approved by FDA for market use on 21 May, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |