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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 two branded drugs marketed by Astrazeneca Pharms, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, Mylan, Strides Pharma, and Torrent, and is included in seven NDAs. There are six 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 twenty-six patent family members in forty-four countries.
There are ten drug master file entries for roflumilast. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for roflumilast
International Patents: | 126 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 10 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 115 |
Clinical Trials: | 79 |
Patent Applications: | 6,932 |
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 |
---|---|
Chiesi Farmaceutici S.p.A. | Phase 3 |
Bispebjerg Hospital | Phase 2 |
University of Calgary | Phase 1 |
Generic filers with tentative approvals for ROFLUMILAST
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 500MCG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for roflumilast
Drug Class | Phosphodiesterase 4 Inhibitor |
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for ROFLUMILAST
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
DALIRESP | TABLET;ORAL | roflumilast | 022522 | 2019-01-25 |
DALIRESP | TABLET;ORAL | roflumilast | 022522 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | RX | Yes | No | Start Trial | Start Trial | Start 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 Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | Start Trial | Start Trial |
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for roflumilast
Country | Patent Number | Estimated Expiration |
---|---|---|
Ukraine | 84266 | Start Trial |
Hong Kong | 1085480 | Start Trial |
Portugal | 1606261 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for roflumilast
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0706513 | SPC/GB10/040 | United Kingdom | Start 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 | PA2010010,C1606261 | Lithuania | Start Trial | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 |
0706513 | C300462 | Netherlands | Start Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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