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Generic Daliresp Availability

Daliresp is a brand name of roflumilast, approved by the FDA in the following formulation(s):

DALIRESP (roflumilast - tablet;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: February 28, 2011
    Strength(s): 500MCG [RLD] [AB]
  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: January 23, 2018
    Strength(s): 250MCG [RLD]

Has a generic version of Daliresp been approved?

A generic version of Daliresp has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Daliresp and have been approved by the FDA:

roflumilast tablet;oral

  • Manufacturer: BRECKENRIDGE PHARM
    Approval date: October 3, 2018
    Strength(s): 500MCG [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: November 23, 2018
    Strength(s): 500MCG [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: August 6, 2018
    Strength(s): 500MCG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Daliresp. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors
    Patent 5,712,298
    Issued: January 27, 1998
    Inventor(s): Amschler; Hermann
    Assignee(s): BYK Gulden Lomberg Chemische Fabrik GmbH

    Compounds of formula (I), in which one of the substituents R1 or R2 stands for hydrogen, 1-6C-alkoxy, 3-7C-cycloalkoxy, 3-7C-cycloalkylmethoxy, benzyloxy or totally or partially fluorine-substituted 1-4C-alkoxy, and the other stands for totally or partially fluorine-substituted 1-4C-alkoxy, and R3 stands for phenyl, pyridyl, R31, R32 and R33-substituted phenyl or R34, R35, R36 and R37-substituted pyridyl, in which R31 stands for hydroxy, halogen, cyano, carboxyl, trifluoromethyl 1-4C-alkyl, 1-4C-alkoxy, 1-4C-alkoxycarbonyl, 1-4C-alkylcarbonyl, 1-4C-alkylcarbonyloxy, amino, mono- or di-1-4C-alkylamino or 1-4C-alkylcarbonylamino; R32 stands for hydrogen, hydroxy, halogen, amino, trifluoromethyl, 1-4C-alkyl or 1-4C-alkoxy; R33 stands for hydrogen, halogen, 1-4C-alkyl or 1-4C-alkoxy; R34 stands for hydroxy, halogen, cyano, carboxyl, 1-4C-alkyl, 1-4C-alkoxy, 1-4C-alkoxycarbonyl or amino; R35 stands for hydrogen, halogen, amino or 1-4C-alkyl; R36 stands for hydrogen or halogen; and R37 stands for hydrogen or halogen. These compounds constitute new effective bronchotherapeutic drugs. ##STR1##

    Patent expiration dates:

    • January 27, 2020
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      Patent use: TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
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      Drug substance
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      Drug product
  • Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient
    Patent 8,431,154
    Issued: April 30, 2013
    Assignee(s): Takeda GmbH

    Dosage forms for oral administration of a PDE 4 inhibitor whose solubility is slight are described. They contain PVP as binder.

    Patent expiration dates:

    • February 19, 2023
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      Drug product
  • Process for the preparation of roflumilast
    Patent 8,536,206
    Issued: September 17, 2013
    Assignee(s): Takeda GmbH

    The invention relates to novel processes for the preparation of high-purity roflumilast.

    Patent expiration dates:

    • March 8, 2024
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      Patent 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 8,604,064
    Issued: December 10, 2013
    Assignee(s): Takeda GmbH

    A method for the treatment of chronic obstructive pulmonary disease (COPD), including administering to a patient suffering from COPD, a therapeutically effective amount of roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.

    Patent expiration dates:

    • March 8, 2024
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      Patent 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 8,618,142
    Issued: December 31, 2013
    Assignee(s): Takeda GmbH

    A composition comprising: roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.

    Patent expiration dates:

    • March 8, 2024
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  • Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient
    Patent 9,468,598
    Issued: October 18, 2016
    Assignee(s): AstraZeneca AB

    Dosage forms for oral administration of a PDE 4 inhibitor whose solubility is slight are described. They contain PVP as binder.

    Patent expiration dates:

    • February 19, 2023
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Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • August 31, 2020 - INFORMATION ADDED TO THE LABELING TO INCLUDE RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
    • January 23, 2021 - NEW STRENGTH
    • January 23, 2021 - REVISED DOSING TO INCLUDE UP-TITRATION AS A STRATEGY TO IMPROVE TOLERABILITY AND THEREBY REDUCE TREATMENT DISCONTINUATION FOR ROFLUMILAST MAINTENANCE DOSAGE OF 500 MCG DAILY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

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