FDA Approves Generic Versions of Suboxone Film, Indivior Sues to Block

On June 14, 2018, the US Food and Drug Administration (FDA) approved a generic version of Suboxone sublingual film. The federal government is trying to increase accessibility to Medication Assisted Treatment (MAT) and making the medication less expensive is one way to make it easier for patients to access MAT.

According the FDA press release:

“One of the ways the FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. In an effort to promote competition to help reduce drug prices and improve access to safe and effective generic medicines for Americans, the agency is taking a number of new steps as part of its Drug Competition Action Plan. This includes important work to improve the efficiency of the generic drug approval process and address barriers to generic drug development. Generic drugs approved by the FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.”

— FDA Press Release June 14, 2018

Initially, two generic pharmaceutical companies announced that they will be marketing the generic Suboxone, Mylan Technologies Inc. and Dr. Reddy's Laboratories SA in multiple strengths.

However, within days of the FDA approval, Indivior, the maker of Suboxone, sued Dr. Reddy's, the Indian generic drug producer for patent infringement. According to FiercePharma, a US court issued a temporary restraining order against Dr. Reddy's. Dr. Reddy's had attempted an "at risk" launch of the generic film, but was quickly forced to respond to litigation from Indivior.

Mylan previously settled a patent infringement suit with Indivior in September of 2017.

Assuming that the generic producs make it to market, it is not clear how insurance companies will change their preferences for various formulations. The majority of MATClinics' patients strongly prefer Suboxone film over the generic tablet, but without any experience with the generic film it is hard to tell how patient preferences may change.

In an informal discussion with Maryland Medicaid, MATClinics was told that if the generic Suboxone film is materially less expensive than the branded film, Medicaid may require prior authorizations for the branded Suboxone going forward.

MATClinics will do its best to keep our patients updated.

Speak to a member of our team to schedule a New Patient visit, or just to get more information.

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