Generic Daliresp Availability
Last updated on Jun 11, 2025.
Daliresp is a brand name of roflumilast, approved by the FDA in the following formulation(s):
DALIRESP (roflumilast - tablet;oral)
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Manufacturer: ASTRAZENECA
Approval date: February 28, 2011
Strength(s): 500MCG [RLD] [AB] -
Manufacturer: ASTRAZENECA
Approval date: January 23, 2018
Strength(s): 250MCG [RLD] [AB]
Is there a generic version of Daliresp available?
Yes. The following products are equivalent to Daliresp:
roflumilast tablet;oral
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Manufacturer: ALKEM LABS LTD
Approval date: April 18, 2023
Strength(s): 250MCG [AB], 500MCG [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: April 17, 2023
Strength(s): 500MCG [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: January 31, 2025
Strength(s): 250MCG [AB] -
Manufacturer: HETERO LABS LTD III
Approval date: November 23, 2018
Strength(s): 500MCG [AB] -
Manufacturer: HETERO LABS LTD III
Approval date: April 18, 2023
Strength(s): 250MCG [AB] -
Manufacturer: MICRO LABS
Approval date: March 22, 2019
Strength(s): 500MCG [AB] -
Manufacturer: MICRO LABS
Approval date: April 18, 2023
Strength(s): 250MCG [AB] -
Manufacturer: MSN
Approval date: September 7, 2022
Strength(s): 250MCG [AB], 500MCG [AB] -
Manufacturer: NORVIUM BIOSCIENCE
Approval date: July 13, 2018
Strength(s): 500MCG [AB] -
Manufacturer: PRINSTON INC
Approval date: May 10, 2022
Strength(s): 500MCG [AB] -
Manufacturer: STRIDES PHARMA
Approval date: March 30, 2020
Strength(s): 500MCG [AB] -
Manufacturer: STRIDES PHARMA
Approval date: June 20, 2023
Strength(s): 250MCG [AB] -
Manufacturer: TORRENT
Approval date: October 18, 2024
Strength(s): 250MCG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: February 10, 2022
Strength(s): 500MCG [AB] -
Manufacturer: ZYDUS PHARMS
Approval date: April 18, 2023
Strength(s): 250MCG [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 FAQ.
More about Daliresp (roflumilast)
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- During pregnancy
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- Drug class: selective phosphodiesterase-4 inhibitors
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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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
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