Roflumilast - Generic Drug Details
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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 fourteen NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Roflumilast has eighty-five patent family members in twenty-nine countries.
There are ten drug master file entries for roflumilast. Fourteen suppliers are listed for this compound.
Summary for roflumilast
International Patents: | 85 |
US Patents: | 16 |
Tradenames: | 3 |
Applicants: | 13 |
NDAs: | 14 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 136 |
Clinical Trials: | 99 |
Patent Applications: | 7,299 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for roflumilast
Paragraph IV (Patent) Challenges for ROFLUMILAST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZORYVE | Cream | roflumilast | 0.3% | 215985 | 1 | 2023-12-27 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Prinston Inc | ROFLUMILAST | roflumilast | TABLET;ORAL | 208299-001 | May 10, 2022 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Msn | ROFLUMILAST | roflumilast | TABLET;ORAL | 208256-001 | Sep 7, 2022 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-002 | Jul 9, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Hetero Labs Ltd Iii | ROFLUMILAST | roflumilast | TABLET;ORAL | 208213-001 | Nov 23, 2018 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 | 022522-001 | Feb 28, 2011 | 5,712,298 | ⤷ Subscribe |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | 8,536,206 | ⤷ Subscribe |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | 5,712,298 | ⤷ Subscribe |
Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | 8,618,142 | ⤷ Subscribe |
>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 |
---|---|---|---|
Denmark | 1606261 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2004080967 | ⤷ Subscribe | |
Israel | 168170 | PROCESS FOR THE PREPARATION OF ROFLUMILAST | ⤷ Subscribe |
Slovenia | 1606261 | ⤷ Subscribe | |
>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 | ⤷ Subscribe | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
0706513 | C300462 | Netherlands | ⤷ Subscribe | PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
1606261 | C20100008 00033 | Estonia | ⤷ Subscribe | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
0706513 | SPC/GB10/040 | United Kingdom | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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