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Last Updated: February 27, 2021

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Roflumilast - Generic Drug Details

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What are the generic sources for roflumilast and what is the scope of freedom to operate?

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.

Recent Clinical Trials for roflumilast

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 3
Bispebjerg HospitalPhase 2
University of CalgaryPhase 1

See all roflumilast clinical trials

Generic filers with tentative approvals for ROFLUMILAST
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MCGTABLET;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
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
Breckenridge ROFLUMILAST roflumilast TABLET;ORAL 208236-001 Oct 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms DALIRESP roflumilast TABLET;ORAL 022522-001 Feb 28, 2011 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Torrent ROFLUMILAST roflumilast TABLET;ORAL 208272-001 Aug 6, 2018 AB RX No No   Start Trial   Start Trial   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

Supplementary Protection Certificates for roflumilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1606261 C 2010 014 Romania   Start Trial 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
1606261 C20100008 00033 Estonia   Start Trial PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
0706513 1090034-8 Sweden   Start Trial PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
0706513 10C0052 France   Start 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 CA 2010 00028 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
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Merck
Johnson and Johnson

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