Roflumilast Patent Expiration

1. Daliresp patent expiration

DALIRESP's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5712298 ASTRAZENECA Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors
Jan, 2020

(4 years ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5712298 ASTRAZENECA Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors
Jan, 2015

(9 years ago)

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

(1 year, 4 months ago)

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

(1 year, 4 months ago)

US8604064 ASTRAZENECA Process for the preparation of roflumilast
Mar, 2024

(4 months ago)

US8536206 ASTRAZENECA Process for the preparation of roflumilast
Mar, 2024

(4 months ago)

US8618142 ASTRAZENECA Process for the preparation of roflumilast
Mar, 2024

(4 months ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Feb 28, 2016
M(M-208) Aug 31, 2020
New Strength(NS) Jan 23, 2021
New Dosing Schedule(D-171) Jan 23, 2021

NCE-1 date: 28 February, 2015

Market Authorisation Date: 23 January, 2018

Treatment: Treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations

Dosage: TABLET

How can I launch a generic of DALIRESP before it's drug patent expiration?
More Information on Dosage

DALIRESP family patents

Family Patents

2. Zoryve patent expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11819496 ARCUTIS Topical roflumilast formulation having improved delivery and plasma half-life
Jun, 2037

(12 years from now)

US10940142 ARCUTIS Inhibition of crystal growth of roflumilast
Jun, 2037

(12 years from now)

US9884050 ARCUTIS Inhibition of crystal growth of roflumilast
Jun, 2037

(12 years from now)

US11793796 ARCUTIS Inhibition of crystal growth of roflumilast
Jun, 2037

(12 years from now)

US9907788 ARCUTIS Inhibition of crystal growth of roflumilast
Jun, 2037

(12 years from now)

US11129818 ARCUTIS Topical roflumilast formulation having improved delivery and plasma half life
Aug, 2037

(13 years from now)

US11707454 ARCUTIS Topical roflumilast formulation having antifungal properties
Dec, 2041

(17 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 15, 2026

Market Authorisation Date: 15 December, 2023

Treatment: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older; Topical treatment of seborrheic dermatitis in patients 9 years of age and older

Dosage: FOAM

More Information on Dosage

ZORYVE family patents

Family Patents