Four Things to Know About Roflumilast, Generic Daliresp

Breathing can be extremely difficult for approximately 16 million Americans who suffer from Chronic obstructive pulmonary disease (COPD). In fact, shortness of breath, frequent coughing and wheezing, and excess phlegm and mucus production caused by chronic lower respiratory disease is a leading cause of death in the U.S. Medications such as Daliresp, and its generic roflumilast can help.

Roflumilast, the generic form of Daliresp has been approved by the Food and Drug Administration (FDA) and may be made available soon, making this COPD medication more affordable. Here are four things to know about roflumilast, the generic for Daliresp.

What is roflumilast?

Roflumilast is the active ingredient in the brand drug Daliresp. It is used to treat symptoms of severe COPD including wheezing and shortness of breath caused by chronic inflammation of the airways. Roflumilast belongs to a category of drugs known as phosphodiesterase-4 inhibitors (PDE4 Inhibitor).

When will roflumilast be available?

Currently, there are four generic versions of Daliresp approved by the FDA, which may become available in 2021. Keep in mind that generic drug release dates are subject to change based on litigation, patent expirations, and drug exclusivities. The generics that have been approved include:

• Roflumilast 500 mcg tablets manufactured by Breckenridge Pharmaceutical INC
• Roflumilast 500 mcg tablets manufactured by Hetero Labs LTD Unit III
• Roflumilast 500 mcg tablets manufactured by Micro Labs LTD
• Roflumilast 500 mcg tablets manufactured by Torrent Pharmaceuticals LTD

How does Daliresp work?

Daliresp and its generic, roflumilast, work by helping to reduce irritation and swelling of your airways to enable easier breathing. Daliresp and roflumilast should be used in conjunction with other medications, including bronchodilators to keep your airways clear. Daliresp and roflumilast are not fast-acting medications. Both need to be taken daily to be effective.

How does a brand drug become a generic drug?

There is a stringent process by which brand-name drugs become generics that is well-regulated by the FDA.

Brand-name drugs have patents that are valid for 20 years after the filing of the patent application. However, a large amount of that time is spent developing the drug, so the length of time the brand drug is on the market before the patent exclusion expires is usually only a few years.

A generic manufacturer can apply to make a generic drug before this patent has expired, but cannot release the new generic version of the drug on the market until the patent expires.

Standards Generic Medications Must Meet to Become FDA Approved

Manufacturers of generic medications must submit an Abbreviated New Drug Application (ANDA) to the FDA proving that the generic drug has the same quality, strength, and safety as the brand-name product. The submitted ANDA must demonstrate that:

• The generic drug is equivalent to the brand name drug in formulation (i.e., tablet, solution, extended-release, etc.)
• The manufacturer can make the drug correctly and consistently
• The active ingredient is the same as the one in the brand-name drug
• The established amount of the drug always reaches the site of action in the same amount of time
• The inactive ingredients are safe
• The drug is stable for a reasonable amount of time.
• The container used for the drug is appropriate for the stability of the drug
• The drug information label is the same as that of the brand-name drug
• The brand-name drug’s patents and exclusivities have expired

How much does Daliresp cost?

Daliresp is a brand drug, and it can be expensive. When roflumilast, the generic for Daliresp becomes available, the price will likely be reduced significantly. The FDA reports that generic medications are typically 80-85% cheaper than their brand drug counterpart.

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