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
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 | 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.
Latest 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 |
|---|---|---|
 | ||
| Electronic Review Critical | 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 Critical | 11 Mar, 2024 | US9884050 |
| Mail-Petition Decision - Dismissed Critical | 07 Mar, 2024 | US9884050 |
| Petition Decision - Dismissed Critical | 06 Mar, 2024 | US9884050 |
| O.P. Petition Decision | 05 Mar, 2024 | US9884050 |
| Mail O.P. Petition Decision | 12 Feb, 2024 | US11819496 |
| Email Notification Critical | 12 Feb, 2024 | US11819496 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 08 Feb, 2024 | US11819496 |
Roflumilast's 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 Norvium Bioscience 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.
1. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MCG | tablet | Prescription | ORAL | AB | Apr 18, 2023 |
| 500MCG | tablet | Prescription | ORAL | AB | Apr 18, 2023 |
2. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Apr 17, 2023 |
| 250MCG | tablet | Prescription | ORAL | AB | Jan 31, 2025 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
3. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Nov 23, 2018 |
| 250MCG | tablet | Prescription | ORAL | AB | Apr 18, 2023 |
4. MICRO LABS
Micro Labs Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Micro Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Mar 22, 2019 |
| 250MCG | tablet | Prescription | ORAL | AB | Apr 18, 2023 |
Manufacturing Plant Locations New
Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||
5. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Sep 7, 2022 |
| 250MCG | tablet | Prescription | ORAL | AB | Sep 7, 2022 |
Manufacturing Plant Locations New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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6. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 1 generic for Roflumilast. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Jul 13, 2018 |
7. PRINSTON INC
Prinston Pharmaceutical Inc has filed for 1 generic for Roflumilast. Given below are the details of the strengths of this generic introduced by Prinston Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | May 10, 2022 |
8. SENORES PHARMS
Senores Pharmaceuticals Inc has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Senores Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Discontinued | ORAL | N/A | Oct 3, 2018 |
| 250MCG | tablet | Discontinued | ORAL | N/A | Oct 19, 2023 |
9. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Mar 30, 2020 |
| 250MCG | tablet | Prescription | ORAL | AB | Jun 20, 2023 |
Manufacturing Plant Locations New
Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
| India |
| |||||
10. TORRENT
Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Torrent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Discontinued | ORAL | N/A | Aug 6, 2018 |
| 250MCG | tablet | Prescription | ORAL | AB | Oct 18, 2024 |
Manufacturing Plant Locations New
Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||
| United States |
| |||||||||||
11. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Roflumilast. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MCG | tablet | Prescription | ORAL | AB | Feb 10, 2022 |
| 250MCG | tablet | Prescription | ORAL | AB | Apr 18, 2023 |