DALIRESP Drug Patent Profile
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When do Daliresp patents expire, and when can generic versions of Daliresp launch?
Daliresp is a drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-seven patent family members in twenty-nine countries.
The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Daliresp
A generic version of DALIRESP was approved as roflumilast by MYLAN on July 13th, 2018.
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Summary for DALIRESP
| International Patents: | 37 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 17 |
| Patent Applications: | 5,683 |
| Drug Prices: | Drug price information for DALIRESP |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DALIRESP |
| What excipients (inactive ingredients) are in DALIRESP? | DALIRESP excipients list |
| DailyMed Link: | DALIRESP at DailyMed |
Recent Clinical Trials for DALIRESP
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiesi Farmaceutici S.p.A. | Phase 3 |
| Johns Hopkins University | Phase 3 |
| Patient-Centered Outcomes Research Institute | Phase 3 |
Pharmacology for DALIRESP
| Drug Class | Phosphodiesterase 4 Inhibitor |
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Paragraph IV (Patent) Challenges for DALIRESP
| 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 DALIRESP
DALIRESP is protected by three US patents.
Patents protecting DALIRESP
Process for the preparation of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Process for the preparation of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Process for the preparation of roflumilast
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 DALIRESP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-002 | Jan 23, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | DALIRESP | roflumilast | TABLET;ORAL | 022522-001 | Feb 28, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DALIRESP
| 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 DALIRESP
See the table below for patents covering DALIRESP around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 20043904 | ⤷ Sign Up | |
| Poland | 226401 | ⤷ Sign Up | |
| South Korea | 20040084926 | ⤷ Sign Up | |
| Germany | 122010000043 | ⤷ Sign Up | |
| Spain | 2335498 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DALIRESP
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1606261 | C20100008 00033 | Estonia | ⤷ Sign Up | PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010 |
| 0706513 | SPC031/2010 | Ireland | ⤷ Sign Up | SPC031/2010: 20110906, EXPIRES: 20190701 |
| 1606261 | C 2010 014 | Romania | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705 |
| 0706513 | 34/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705 |
| 0706513 | SPC/GB10/040 | United Kingdom | ⤷ Sign Up | 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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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.
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