Tudorza Pressair is a drug owned by Covis Pharma Gmbh. It is protected by 13 US drug patents filed from 2013 to 2021. Out of these, 4 drug patents are active and 9 have expired. Tudorza Pressair's patents have been open to challenges since 23 July, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2029. Details of Tudorza Pressair'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. | |||
| USRE46417 | Quinuclidine derivatives and their use as muscarinic M3 receptor ligands |
Feb, 2025
(2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11000517 | Dosage and formulation |
Mar, 2029
(4 years from now) | Active |
| US10085974 | Dosage and formulation |
Mar, 2029
(4 years from now) | Active |
| US8051851 | Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler |
Apr, 2027
(2 years from now) | Active |
| US6681768 | Powder formulation disintegrating system and method for dry powder inhalers |
Aug, 2022
(2 years ago) |
Expired
|
| US6750226 | Quinuclidine derivatives and their use as muscarinic M3 receptor ligands |
Sep, 2020
(4 years ago) |
Expired
|
| US7078412 | Quinuclidine derivatives and medicinal compositions containing the same |
Jul, 2020
(4 years ago) |
Expired
|
| US10588895 | Quinuclidine derivatives and medicinal compositions containing the same |
Jul, 2020
(4 years ago) |
Expired
|
| US9056100 | Quinuclidine derivatives and medicinal compositions containing the same |
Jul, 2020
(4 years ago) |
Expired
|
| US9333195 | Quinuclidine derivatives and medicinal compositions containing the same |
Jul, 2020
(4 years ago) |
Expired
|
| US10034867 | Quinuclidine derivatives and medicinal compositions containing the same |
Jul, 2020
(4 years ago) |
Expired
|
| US6071498 | Inhaler for powdered medicaments |
Jun, 2016
(8 years ago) |
Expired
|
| US5840279 | Pharmaceutical powder cartridge with integrated metering device and inhaler for powdered medicaments |
Jun, 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 Tudorza Pressair's patents.
Latest Legal Activities on Tudorza Pressair's Patents
Given below is the list of recent legal activities going on the following patents of Tudorza Pressair.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| FDA Final Eligibility Letter Critical | 07 Dec, 2015 | US6750226 |
| transaction for FDA Determination of Regulatory Review Period | 04 May, 2015 | US6750226 |
| transaction for FDA Determination of Regulatory Review Period | 19 Mar, 2015 | US6750226 |
| Correspondence Address Change Critical | 20 Nov, 2014 | US6750226 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Nov, 2014 | US6750226 |
| Second letter to regulating agency to determine regulatory review period | 10 Jun, 2014 | US6750226 |
| Letter from FDA or Dept of Agriculture re PTE application | 16 Jul, 2013 | US6750226 |
| Initial letter Re: PTE Application to regulating agency | 11 Apr, 2013 | US6750226 |
| Patent Term Extension Application under 35 USC 156 Filed | 19 Sep, 2012 | US6750226 |
| Recordation of Patent Grant Mailed Critical | 09 Aug, 2005 | US6750226 |
FDA has granted several exclusivities to Tudorza Pressair. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tudorza Pressair, 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 Tudorza Pressair.
Exclusivity Information
Tudorza Pressair holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Tudorza Pressair's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2017 |
| M(M-256) | Mar 29, 2022 |
Several oppositions have been filed on Tudorza Pressair'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 Tudorza Pressair's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tudorza Pressair patents.
Tudorza Pressair's Oppositions Filed in EPO
Tudorza Pressair has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 06, 2016, by Hexal Ag. This opposition was filed on patent number EP09719213A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09719213A | May, 2016 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP09719213A | May, 2016 | Hexal AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tudorza Pressair 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 Tudorza Pressair's family patents as well as insights into ongoing legal events on those patents.
Tudorza Pressair's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tudorza Pressair's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tudorza Pressair Generics:
There are no approved generic versions for Tudorza Pressair as of now.
Alternative Brands for Tudorza Pressair
Tudorza Pressair which is used for managing symptoms of chronic obstructive pulmonary disease (COPD)., has several other brand drugs in the same treatment category and using the same active ingredient (Aclidinium 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 | Treatment Area | ||
|---|---|---|---|---|
| Covis |
| |||
About Tudorza Pressair
Tudorza Pressair is a drug owned by Covis Pharma Gmbh. It is used for managing symptoms of chronic obstructive pulmonary disease (COPD). Tudorza Pressair uses Aclidinium Bromide as an active ingredient. Tudorza Pressair was launched by Covis in 2012.
Approval Date:
Tudorza Pressair was approved by FDA for market use on 23 July, 2012.
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 Tudorza Pressair is 23 July, 2012, its NCE-1 date is estimated to be 23 July, 2016.
Active Ingredient:
Tudorza Pressair uses Aclidinium Bromide as the active ingredient. Check out other Drugs and Companies using Aclidinium Bromide ingredient
Treatment:
Tudorza Pressair is used for managing symptoms of chronic obstructive pulmonary disease (COPD).
Dosage:
Tudorza Pressair is available in powder, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.4MG/INH | POWDER, METERED | Prescription | INHALATION |