Roflumilast - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for roflumilast and what is the scope of patent protection?
Roflumilast
is the generic ingredient in three branded drugs marketed by Arcutis, Astrazeneca, Alkem Labs Ltd, Aurobindo Pharma Ltd, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in thirteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Roflumilast has one hundred and seventeen patent family members in thirty-six countries.
There are ten drug master file entries for roflumilast. Twelve suppliers are listed for this compound.
Summary for roflumilast
International Patents: | 117 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 13 |
NDAs: | 13 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 136 |
Clinical Trials: | 99 |
Patent Applications: | 7,026 |
Drug Prices: | Drug price trends for roflumilast |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for roflumilast |
What excipients (inactive ingredients) are in roflumilast? | roflumilast excipients list |
DailyMed Link: | roflumilast at DailyMed |
Recent Clinical Trials for roflumilast
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mansoura University | Phase 1/Phase 2 |
Jacob Pontoppidan Thyssen | Phase 4 |
The Novo Nordic Foundation | Phase 4 |
Pharmacology for roflumilast
Drug Class | Phosphodiesterase 4 Inhibitor |
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for ROFLUMILAST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DALIRESP | Tablets | roflumilast | 250 mcg | 022522 | 1 | 2019-01-25 |
DALIRESP | Tablets | roflumilast | 500 mcg | 022522 | 7 | 2015-03-02 |
US Patents and Regulatory Information for roflumilast
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd Iii | ROFLUMILAST | roflumilast | TABLET;ORAL | 208213-001 | Nov 23, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Torrent | ROFLUMILAST | roflumilast | TABLET;ORAL | 208272-001 | Aug 6, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-001 | Jul 29, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for roflumilast
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for roflumilast
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AstraZeneca AB | Daxas | roflumilast | EMEA/H/C/001179 Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment., |
Authorised | no | no | no | 2010-07-05 | |
AstraZeneca AB | Libertek | roflumilast | EMEA/H/C/002399 Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment. |
Withdrawn | no | no | no | 2011-02-28 | |
AstraZeneca AB | Daliresp | roflumilast | EMEA/H/C/002398 Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment. |
Withdrawn | no | no | no | 2011-02-28 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for roflumilast
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Malaysia | 140561 | DOSAGE FORM CONTAINING PDE 4 INHIBITOR AS ACTIVE INGREDIENT | ⤷ Try a Trial |
South Korea | 20200016940 | 로플루밀라스트의 결정 성장의 저해 | ⤷ Try a Trial |
Spain | 2335498 | ⤷ Try a Trial | |
Canada | 2503290 | NOUVEAU PROCEDE DE PREPARATION DE ROFLUMILAST (NOVEL PROCESS FOR THE PREPARATION OF ROFLUMILAST) | ⤷ Try a Trial |
Poland | 370595 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for roflumilast
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1606261 | PA2010010,C1606261 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
1606261 | PA2010010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
0706513 | 10C0052 | France | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705 |
0706513 | SPC/GB10/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705 |
1606261 | C20100008 00033 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.