Now Available: Naproxen and Esomeprazole Generic for Vimovo

Generic drugs play an essential role in our health care. Sixty-five percent of prescriptions in the United States are generics. Generic formulations are crucial in keeping up with the increasing patient demand for medications and save consumers over $10 million per year in prescription costs. The process by which brand name drugs become available as generics is rigorous and well regulated by the Food and Drug Administration (FDA).

How Does a Drug Become Generic?

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. Another pharmaceutical manufacturer can apply to make a generic version of a drug before this patent has expired but cannot release the new generic version on the market until the patent expires. The generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA, showing 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

The generic manufacturer is not required to submit animal studies or human clinical studies. Instead, they are required to prove the bioequivalence of the product.

What Is Bioequivalence?

A generic drug is bioequivalent to the brand name product if the active ingredient is available at the site of intended action (bloodstream, skin, lungs, etc.) within the same amount of time as the original drug.

Naproxen and Esomeprazole – Generic Vimovo

The FDA approved Dr. Reddy’s Laboratories LTD to manufacture a generic version of Vimovo®. Generic products may be available in July of 2020, but keep in mind that generic drug release dates are subject to change based on litigation, patent expirations, and drug exclusivities.

Vimovo (naproxen and esomeprazole) is a combination medication containing the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the acid reflux medication esomeprazole. Naproxen helps to relieve pain and inflammation, while esomeprazole reduces stomach acid production. Vimovo is used to treat the following:

• Symptoms of arthritis
• Symptoms of ankylosing spondylitis (an inflammatory condition that can cause fusing of the bones in your spine)
• Decrease the risk of stomach ulcers in patients more likely to develop ulcers due to NSAID treatment

Keep in mind the following points if you are taking Vimovo:

• Swallow Vimovo tablets whole. Do not chew, cut, dissolve, or crush the tablets.
• NSAIDs may increase your risk of having a stroke, heart attack, and blood clots.
• Vimovo should not be used for pain during artery bypass surgery.
• NSAIDs can cause stomach or intestinal bleeding or ulcers.
• Do not use Vimovo if you are allergic to aspirin or other NSAIDs.
• Using Vimovo for a long time can cause kidney damage.
• Using Vimovo with blood thinners, such as warfarin (Coumadin), may increase the chance of bleeding.
• Vimovo may decrease the effects of clopidogrel (Plavix)

The usual dose of Vimovo is one tablet twice a day, but your doctor may prescribe a different dose based on your kidney function and your condition. The average retail price for 60 Vimovo 375-20 mg tablets is about $2,600. Generic drugs cost about 80% to 85% less than brand name drugs, and the arrival of generic Vimovo can provide significant savings.