Spiriva Respimat is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 39 US drug patents filed from 2014 to 2017. Out of these, 11 drug patents are active and 28 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 16, 2031. Details of Spiriva 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. | |||
| 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 (Pediatric) | Atomizer and method of atomizing fluid with a nozzle rinsing mechanism |
Apr, 2031
(6 years from now) | Active |
| 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 |
|
US9027967 (Pediatric) | Device for clamping a fluidic component |
Oct, 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 |
| 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 (Pediatric) | Microstructured high pressure nozzle with built-in filter function |
Nov, 2025
(1 year, 10 days from now) | Active |
| US7896264 | Microstructured high pressure nozzle with built-in filter function |
May, 2025
(6 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
|
|
US7988001 (Pediatric) | Container provided with a pressure equalization opening |
Feb, 2022
(2 years 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
|
| US6977042 | Microstructured filter |
Aug, 2018
(6 years ago) |
Expired
|
| US6846413 | Microstructured filter |
Aug, 2018
(6 years ago) |
Expired
|
|
USRE39820 (Pediatric) | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
Jul, 2018
(6 years ago) |
Expired
|
|
US6149054 (Pediatric) | Mechanical counter for a metering apparatus |
Jun, 2017
(7 years ago) |
Expired
|
|
US6453795 (Pediatric) | Locking mechanism for a spring-actuated device |
Jun, 2017
(7 years ago) |
Expired
|
|
US7104470 (Pediatric) | Device for producing high pressure in a fluid in miniature |
Apr, 2017
(7 years ago) |
Expired
|
|
US5964416 (Pediatric) | Device for producing high pressure in a fluid in miniature |
Apr, 2017
(7 years ago) |
Expired
|
|
US6726124 (Pediatric) | Device for producing high pressure in a fluid in miniature |
Apr, 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 (Pediatric) | Device for mounting a component exposed to a pressurized fluid |
Dec, 2016
(7 years ago) |
Expired
|
|
US7246615 (Pediatric) | Atomising nozzle and filter and spray generating device |
Dec, 2016
(7 years ago) |
Expired
|
| US6726124 | Device for producing high pressure in a fluid in miniature |
Oct, 2016
(8 years ago) |
Expired
|
| US7104470 | 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
|
| US6176442 | Device for mounting a component exposed to a pressurized fluid |
May, 2016
(8 years ago) |
Expired
|
| US6176242 | Method of treating manic depression by brain infusion |
May, 2016
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Spiriva Respimat. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Spiriva 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 Spiriva Respimat.
Exclusivity Information
Spiriva Respimat holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Spiriva Respimat's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 15, 2018 |
| New Patient Population(NPP) | Feb 15, 2020 |
| Pediatric Exclusivity(PED) | Aug 15, 2020 |
Several oppositions have been filed on Spiriva 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 Spiriva Respimat's generic, the next section provides detailed information on ongoing and past EP oppositions related to Spiriva Respimat patents.
Spiriva Respimat's Oppositions Filed in EPO
Spiriva 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 |
|---|---|---|---|
 | |||
| EP2004006768W | Apr, 2012 | Knorr-Bremse Systeme für Nutzfahrzeuge GmbH | Revoked |
US patents provide insights into the exclusivity only within the United States, but Spiriva 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 Spiriva Respimat's family patents as well as insights into ongoing legal events on those patents.
Spiriva Respimat's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Spiriva Respimat's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 16, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Spiriva Respimat Generic API suppliers:
Tiotropium Bromide is the generic name for the brand Spiriva Respimat. 1 company has already filed for the generic of Spiriva Respimat. Check out the entire list of companies who have already received approval for Spiriva Respimat's generic
How can I launch a generic of Spiriva Respimat before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Spiriva Respimat's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Spiriva Respimat's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Spiriva Respimat -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mcg per actuation | 07 Mar, 2023 | 1 | 16 Apr, 2031 |
Alternative Brands for Spiriva Respimat
Spiriva Respimat which is used for managing bronchospasm associated with COPD and reducing exacerbations in COPD patients., has several other brand drugs using the same active ingredient (Tiotropium Bromide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Boehringer Ingelheim |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tiotropium Bromide, Spiriva Respimat's active ingredient. Check the complete list of approved generic manufacturers for Spiriva Respimat
About Spiriva Respimat
Spiriva Respimat is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for managing bronchospasm associated with COPD and reducing exacerbations in COPD patients. Spiriva Respimat uses Tiotropium Bromide as an active ingredient. Spiriva Respimat was launched by Boehringer Ingelheim in 2015.
Approval Date:
Spiriva Respimat was approved by FDA for market use on 15 September, 2015.
Active Ingredient:
Spiriva Respimat uses Tiotropium Bromide as the active ingredient. Check out other Drugs and Companies using Tiotropium Bromide ingredient
Treatment:
Spiriva Respimat is used for managing bronchospasm associated with COPD and reducing exacerbations in COPD patients.
Dosage:
Spiriva Respimat is available in spray, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.00125MG BASE/INH | SPRAY, METERED | Prescription | INHALATION |
| EQ 0.0025MG BASE/INH | SPRAY, METERED | Prescription | INHALATION |