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Last Updated: March 4, 2021

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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

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
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

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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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
McKinsey
Baxter
Colorcon
Johnson and Johnson

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