Spiriva is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 20 US drug patents filed from 2013 to 2017. Out of these, 5 drug patents are active and 15 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 19, 2030. Details of Spiriva's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9010323 | Inhaler and sieve for an inhaler |
Apr, 2030
(4 years from now) | Active |
|
US7694676 (Pediatric) | Dry powder inhaler |
Sep, 2027
(2 years from now) | Active |
| US7694676 | Dry powder inhaler |
Mar, 2027
(1 year, 9 months from now) | Active |
|
US8022082 (Pediatric) | Method for the administration of an anticholinergic by inhalation |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8022082 | Method for the administration of an anticholinergic by inhalation |
Jan, 2026
(8 months from now) | Active |
|
US7070800 (Pediatric) | Inhalable powder containing tiotropium |
Jul, 2022
(2 years ago) |
Expired
|
|
USRE38912 (Pediatric) | Process for preparing powder formulations |
Apr, 2022
(3 years ago) |
Expired
|
|
US7309707 (Pediatric) | Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament |
Mar, 2022
(3 years ago) |
Expired
|
|
US6777423 (Pediatric) | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
Mar, 2022
(3 years ago) |
Expired
|
|
US6908928 (Pediatric) | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
Mar, 2022
(3 years ago) |
Expired
|
|
US7642268 (Pediatric) | Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament |
Mar, 2022
(3 years ago) |
Expired
|
| US7070800 | Inhalable powder containing tiotropium |
Jan, 2022
(3 years ago) |
Expired
|
| USRE38912 | Process for preparing powder formulations |
Oct, 2021
(3 years ago) |
Expired
|
| US7309707 | Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament |
Sep, 2021
(3 years ago) |
Expired
|
| US6908928 | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
Sep, 2021
(3 years ago) |
Expired
|
| US7642268 | Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament |
Sep, 2021
(3 years ago) |
Expired
|
| US6777423 | Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions |
Sep, 2021
(3 years ago) |
Expired
|
|
USRE39820 (Pediatric) | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
Jul, 2018
(6 years ago) |
Expired
|
| USRE39820 | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products |
Jan, 2018
(7 years ago) |
Expired
|
| US5478578 | Powders for inhalation |
Dec, 2012
(12 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 Spiriva's patents.
Latest Legal Activities on Spiriva's Patents
Given below is the list of recent legal activities going on the following patents of Spiriva.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Mar, 2023 | US8022082 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Oct, 2022 | US9010323 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Oct, 2021 | US7694676 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Jun, 2021 | US7642268 |
| Email Notification Critical | 09 Feb, 2021 | US7694676 |
| Mail Certificate of Correction Memo | 08 Feb, 2021 | US7694676 |
| Certificate of Correction Memo | 08 Feb, 2021 | US7694676 |
| Post Issue Communication - Certificate of Correction | 08 Feb, 2021 | US7694676 |
| Email Notification Critical | 01 Aug, 2019 | US7694676 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Aug, 2019 | US7694676 |
FDA has granted several exclusivities to Spiriva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Spiriva, 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.
Exclusivity Information
Spiriva holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Spiriva's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-89) | Dec 17, 2012 |
Several oppositions have been filed on Spiriva'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Spiriva patents.
Spiriva's Oppositions Filed in EPO
Spiriva has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 08, 2006, by Pfizer Limited. This opposition was filed on patent number EP01986599A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11194615A | Jun, 2020 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
| EP03745781A | May, 2014 | Actavis Group PTC ehf | Revoked |
| EP03745781A | May, 2014 | Vossius & Partner | Revoked |
| EP03745781A | May, 2014 | Teva UK Limited | Revoked |
| EP01986599A | Dec, 2006 | AstraZeneca AB | Patent maintained as amended |
| EP01986599A | Dec, 2006 | PFIZER LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Spiriva 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's family patents as well as insights into ongoing legal events on those patents.
Spiriva's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Spiriva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 19, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Spiriva Generic API suppliers:
Tiotropium Bromide is the generic name for the brand Spiriva. 1 company has already filed for the generic of Spiriva. Check out the entire list of companies who have already received approval for Spiriva's generic
How can I launch a generic of Spiriva before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Spiriva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Spiriva'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 18 mcg | 11 May, 2018 | 1 | 20 Jun, 2023 | 19 Apr, 2030 | Deferred |
Alternative Brands for Spiriva
Spiriva which is used for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema., 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's active ingredient. Check the complete list of approved generic manufacturers for Spiriva
About Spiriva
Spiriva is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Spiriva uses Tiotropium Bromide as an active ingredient. Spiriva was launched by Boehringer Ingelheim in 2004.
Approval Date:
Spiriva was approved by FDA for market use on 30 January, 2004.
Active Ingredient:
Spiriva uses Tiotropium Bromide as the active ingredient. Check out other Drugs and Companies using Tiotropium Bromide ingredient
Treatment:
Spiriva is used for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Dosage:
Spiriva is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.018MG BASE/INH | POWDER | Prescription | INHALATION |