Daliresp is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 6 US drug patents filed from 2013 to 2018 out of which all have expired. Daliresp's patents have been open to challenges since 28 February, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 08, 2024. Details of Daliresp'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. | |||
| US5712298 | Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors |
Jan, 2020
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8536206 | Process for the preparation of roflumilast |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US8604064 | Process for the preparation of roflumilast |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US8618142 | Process for the preparation of roflumilast |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US8431154 | Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient |
Feb, 2023
(2 years ago) |
Expired
|
| US9468598 | Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient |
Feb, 2023
(2 years ago) |
Expired
|
| US5712298 | Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors |
Jan, 2015
(10 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 Daliresp's patents.
Latest Legal Activities on Daliresp's Patents
Given below is the list of recent legal activities going on the following patents of Daliresp.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 10 Jun, 2024 | US9468598 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8618142 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 May, 2021 | US8604064 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Mar, 2021 | US8536206 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8431154 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Apr, 2020 | US9468598 |
| Recordation of Patent Grant Mailed Critical | 18 Oct, 2016 | US9468598 |
| Patent Issue Date Used in PTA Calculation Critical | 18 Oct, 2016 | US9468598 |
| Email Notification Critical | 29 Sep, 2016 | US9468598 |
| Issue Notification Mailed Critical | 28 Sep, 2016 | US9468598 |
FDA has granted several exclusivities to Daliresp. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Daliresp, 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 Daliresp.
Exclusivity Information
Daliresp holds 4 exclusivities. All of its exclusivities have expired in 2021. Details of Daliresp's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 28, 2016 |
| M(M-208) | Aug 31, 2020 |
| New Dosing Schedule(D-171) | Jan 23, 2021 |
| New Strength(NS) | Jan 23, 2021 |
Several oppositions have been filed on Daliresp'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 Daliresp's generic, the next section provides detailed information on ongoing and past EP oppositions related to Daliresp patents.
Daliresp's Oppositions Filed in EPO
Daliresp has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 20, 2012, by Hexal Ag. This opposition was filed on patent number EP03704652A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10173234A | Feb, 2014 | Generics [UK] Limited | Revoked |
| EP10173234A | Feb, 2014 | Hexal AG | Revoked |
| EP03704652A | Dec, 2012 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Daliresp 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 Daliresp's family patents as well as insights into ongoing legal events on those patents.
Daliresp's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daliresp's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 08, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Daliresp Generic API suppliers:
Roflumilast is the generic name for the brand Daliresp. 11 different companies have already filed for the generic of Daliresp, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Daliresp's generic
How can I launch a generic of Daliresp before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Daliresp's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Daliresp'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 Daliresp -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mcg | 02 Mar, 2015 | 7 | 13 Jul, 2018 | 08 Mar, 2024 | Eligible |
| 250 mcg | 25 Jan, 2019 | 1 | 07 Sep, 2022 | 08 Mar, 2024 | Eligible |
Alternative Brands for Daliresp
Daliresp which is used for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations., has several other brand drugs using the same active ingredient (Roflumilast). 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 | |
|---|---|---|
| Arcutis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Roflumilast, Daliresp's active ingredient. Check the complete list of approved generic manufacturers for Daliresp
About Daliresp
Daliresp is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Daliresp uses Roflumilast as an active ingredient. Daliresp was launched by Astrazeneca in 2018.
Approval Date:
Daliresp was approved by FDA for market use on 23 January, 2018.
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 Daliresp is 23 January, 2018, its NCE-1 date is estimated to be 28 February, 2015.
Active Ingredient:
Daliresp uses Roflumilast as the active ingredient. Check out other Drugs and Companies using Roflumilast ingredient
Treatment:
Daliresp is used for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Dosage:
Daliresp is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MCG | TABLET | Prescription | ORAL |
| 500MCG | TABLET | Prescription | ORAL |