Roflumilast Patent Expiration

Roflumilast is Used for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Daliresp on Feb 28, 2011. Another drug containing Roflumilast is Zoryve. 13 different companies have introduced drugs containing Roflumilast.


Roflumilast Patents

Given below is the list of patents protecting Roflumilast, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zoryve US11707454 Topical roflumilast formulation having antifungal properties Dec 03, 2041 Arcutis
Zoryve US11129818 Topical roflumilast formulation having improved delivery and plasma half life Aug 25, 2037 Arcutis
Zoryve US10940142 Inhibition of crystal growth of roflumilast Jun 07, 2037 Arcutis
Zoryve US11793796 Inhibition of crystal growth of roflumilast Jun 07, 2037 Arcutis
Zoryve US11819496 Topical roflumilast formulation having improved delivery and plasma half-life Jun 07, 2037 Arcutis
Zoryve US11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Jun 07, 2037 Arcutis
Zoryve US12005051 Topical roflumilast formulation having improved delivery and plasma half life Jun 07, 2037 Arcutis
Zoryve US12005052 Topical roflumilast formulation having improved delivery and plasma half-life Jun 07, 2037 Arcutis
Zoryve US12011437 Roflumilast formulations with an improved pharmacokinetic profile Jun 07, 2037 Arcutis
Zoryve US12016848 Roflumilast formulations with an improved pharmacokinetic profile Jun 07, 2037 Arcutis
Zoryve US12042487 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Jun 07, 2037 Arcutis
Zoryve US12220409 Roflumilast formulations with an improved pharmacokinetic profile Jun 07, 2037 Arcutis
Zoryve US12257242 Inhibition of crystal growth of roflumilast Jun 07, 2037 Arcutis
Zoryve US12310956 Topical roflumilast formulation having improved delivery and plasma half-life Jun 07, 2037 Arcutis
Zoryve US9884050 Inhibition of crystal growth of roflumilast Jun 07, 2037 Arcutis
Zoryve US9907788 Inhibition of crystal growth of roflumilast Jun 07, 2037 Arcutis
Daliresp US8536206 Process for the preparation of roflumilast Mar 08, 2024

(Expired)

Astrazeneca
Daliresp US8604064 Process for the preparation of roflumilast Mar 08, 2024

(Expired)

Astrazeneca
Daliresp US8618142 Process for the preparation of roflumilast Mar 08, 2024

(Expired)

Astrazeneca
Daliresp US8431154 Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Feb 19, 2023

(Expired)

Astrazeneca
Daliresp US9468598 Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Feb 19, 2023

(Expired)

Astrazeneca
Daliresp US5712298 Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors Jan 27, 2020

(Expired)

Astrazeneca
Daliresp US5712298 Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors Jan 27, 2015

(Expired)

Astrazeneca



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 Roflumilast's patents.

Given below is the list recent legal activities going on the following patents of Roflumilast.

Activity Date Patent Number
Patent litigations
Electronic Review 07 Jun, 2024 US9884050
Payment of Maintenance Fee, 4th Year, Large Entity 14 May, 2024 US10940142
Mail O.P. Petition Decision 11 Mar, 2024 US9884050
Email Notification 11 Mar, 2024 US9884050
Mail-Petition Decision - Dismissed 07 Mar, 2024 US9884050
Petition Decision - Dismissed 06 Mar, 2024 US9884050
O.P. Petition Decision 05 Mar, 2024 US9884050
Mail O.P. Petition Decision 12 Feb, 2024 US11819496
Email Notification 12 Feb, 2024 US11819496
Mail-Record Petition Decision of Granted to Make Entity Status large 08 Feb, 2024 US11819496


Roflumilast's Family Patents

Family Patents

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Roflumilast Generic API Manufacturers

Several generic applications have been filed for Roflumilast. The first generic version for Roflumilast was by Pharmobedient Consulting Llc and was approved on Jul 13, 2018. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jan 31, 2025.

Given below is the list of companies who have filed for Roflumilast generic, along with the locations of their manufacturing plants worldwide.