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New generic options available for Flector® Patch

by | Mar 27, 2019

Teva Pharmaceuticals has launched an authorized generic version of Flector Patch 1.3% (diclofenac epolamine topical patch), originally manufactured by Pfizer, in the United States (U.S.). Additionally, Greenstone, a Pfizer Company, is also launching an authorized generic version of Flector Patch.

Recommendations for use
Flector Patch is a topical nonsteroidal anti-inflammatory drug (NSAID) indicated to treat acute pain due to minor strains, sprains and contusions in adults, in addition to pediatric patients six years of age and older — children are a recently expanded indication approved by the U.S. Food and Drug Administration (FDA). As with all NSAIDs, diclofenac should be prescribed at the lowest effective dose for the shortest duration of time due to the increased risk of cardiovascular and gastrointestinal adverse events. Furthermore, NSAIDs should be discontinued upon resolution of pain, lack of benefit or development of adverse effects.

Strategy to address potential risks
Topical diclofenac is already available in generic in other FDA-approved formulations.

  • Diclofenac 1% Gel, generic for Voltaren®, is indicated for the relief of pain associated with osteoarthritis of joints amenable to topical treatment, such as the knees and the hands.
  • Diclofenac 1.5% Solution, generic for Pennsaid®, is approved for the treatment of pain related to osteoarthritis of the knee(s). It has not been evaluated for use on other joints. Pennsaid Solution 2% is also available but only as a brand-name product and at a substantially higher price.
  • Diclofenac 3% Gel, generic for Solaraze®, is only approved for actinic keratosis, a precancerous skin lesion caused by damage from exposure to ultraviolet radiation. It should not be used for pain and inflammation.

Diclofenac is available in several oral formulations (e.g., tablets, capsules) for the treatment of mild to moderate pain and inflammation, including signs and symptoms of osteoarthritis and rheumatoid arthritis.

Dosing and pricing
Diclofenac epolamine topical patch by Teva and Greenstone are available in the same strength as brand-name Flector Patch 1.3% and should be dosed in the same manner. At this time, the average wholesale price (AWP) for these authorized generics will result in a savings of approximately $0.75 to $1.50 per patch compared to its brand-name counterpart.

Context for authorized generic
According to the FDA, an authorized generic is identical to a brand-name medication in dosage form, safety, strength, route of administration, quality, performance characteristics, active ingredients, inactive ingredients and intended use and acts the same way in the body as the brand-name medication. However, an authorized generic is not the same as a generic medication. A generic medication has the same active ingredients as the brand-name medication, but may have different inactive ingredients and is made by a company other than the company that makes the brand-name medication.

For more information, please click on the appropriate link under sources

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. Business Wire. Teva Pharmaceutical Industries Ltd. Teva Announces Launch of Authorized Generic of Flector Patch (diclofenac epolamine topical patch) in the United States. March 1, 2019. Available at https://www.businesswire.com/news/home/20190301005551/en/Teva-Announces-Launch -Authorized-Generic-Flector%C2%AE-Patch. Accessed March 20, 2019.
  2. Greenstone LLC. DICLOFENAC EPOLAMINE TOPICAL PATCH 1.3% Product Fact Sheet. Available at https://www.greenstonellc.com/sites/default/files/pdfs/Factsheet/Diclofenac_Epolamine_Patch _FactSheet.pdf. March 22, 2019.
  3. U.S. Food and Drug Administration. FDA List of Authorized Generics. Available at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved
    /approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm126389.htm
    .March 20, 2019. 

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