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Generated: June 27, 2017
What are the generic sources for roflumilast and what is the scope of roflumilast freedom to operate?
Roflumilast is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 8 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 62 |
| Patent Applications: see list | 5,328 |
| Drug Prices: | see low prices |
| DailyMed Link: | roflumilast at DailyMed |
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 500MCG | TABLET;ORAL |
| 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 | 022522-001 | Feb 28, 2011 | RX | Yes | Yes | 9,468,598 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | RX | Yes | Yes | 8,604,064 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | RX | Yes | Yes | 8,431,154 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | RX | Yes | Yes | 5,712,298 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Astrazeneca Pharms | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | RX | Yes | Yes | 8,536,206 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,951,397 | Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient | ► Subscribe | |||||||||||||||||||||||||||
| 7,470,791 | Process for the preparation of roflumilast | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 687087 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 447555 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 332844 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200503191 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 370595 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00462 | 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 | ||||||||||||||||||||||||||
| 2010010,C1606261 | Lithuania | ► Subscribe | PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705 | ||||||||||||||||||||||||||
| C0052 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0706513/01 | Switzerland | ► Subscribe | FORMER OWNER: NYCOMED GERMANY HOLDING GMBH, DE | ||||||||||||||||||||||||||
| 0100008 00033 | Estonia | ► Subscribe | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 | ||||||||||||||||||||||||||
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Serving 500+ 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 verifification 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.
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