Coming Soon: Emtricitabine and Tenofovir Generic for Truvada PrEP

Emtricitabine and Tenofovir – Generic Truvada PrEP

The FDA approved four generic versions of Truvada® for PrEP (pre-exposure prophylaxis), and they may become available in September 2020. However, keep in mind that generic drug release dates are subject to change based on litigation, patent expirations, and drug exclusivities.

• Emtricitabine and tenofovir 200 mg/300 mg tablets manufactured by Aurobindo Pharma, LTD

• Emtricitabine and tenofovir 200 mg/300 mg tablets manufactured by Macleods Pharmaceuticals, LTD

• Emtricitabine and tenofovir 200 mg/300 mg tablets manufactured by Teva Pharmaceuticals USA, INC

• Emtricitabine and tenofovir 200 mg/300 mg tablets manufactured by Zydus Pharmaceuticals USA, INC

Truvada is a combination antiviral medication containing emtricitabine and tenofovir. It is used along with safer sex practices to decrease the risk of infection with human immunodeficiency virus (HIV). Truvada is also used in combination with other drugs to treat HIV infection.

Truvada PrEP is a treatment designed to prevent HIV infection in uninfected people who are at risk for acquiring HIV. Pre-exposure prophylaxis (PrEP) is a medication used daily for people who are at increased risk of HIV exposure and transmission used to prevent this transmission to the uninfected individual. When used daily as PrEP, studies show Truvada effectively reduces the risk of sexually transmitted HIV infection by about 99% and by 74% among injectable drug users.

Pricing for Truvada Today (Brand Medication)

While the average RxSaver price for Truvada at major retail pharmacies costs $1,905 it's important to know there are options to help people save on this overwhelming cost until a generic version is available.

Gilead Advancing Access Program:

Drug manufacturer Gilead offers the Gilead Advancing Access program for those who have been recommended the use of PrEP by their health care provider. The specifics around enrollment depend on a series of qualifying factors so check with your health care provider before applying to ensure acceptance into the program.

RxSaver Advocacy Program:

The RxSaver Advocacy Program, a prescription assistance program, was created to help those who are on high-cost prescription medications to afford their medication regardless of insurance status or income. The program offers relief on costs for brand name medication and expensive generic medications. There is no cost to apply to the program.

How Does Truvada Work?

Truvada PrEP works by preventing HIV from replicating in your body and infecting you permanently. The following are some key points to consider if you are taking Truvada PrEP:

• For maximum effectiveness, you must take Truvada PrEP daily.

• You should not use Truvada PrEP if you are HIV positive. Before initiating PrEP, you must immediately test negative for HIV.

• You and your partner should be tested for HIV every three months while you are taking Truvada PrEP.

• Truvada PrEP only prevents HIV infection. It does not protect you against other sexually transmitted diseases (STDs); therefore, you should continue to use condoms while taking Truvada PrEP.

• Swallow Truvada tablets whole. Do not chew, crush, or break the tablets.

• Common side effects reported with Truvada PrEP include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

• Truvada PrEP can cause kidney damage, including kidney failure. Your health care provider will test your kidney function before you begin taking Truvada PrEP and periodically during treatment.

• Truvada PrEP can cause severe liver problems, especially if you have had hepatitis B or you have a history of liver problems. Let your doctor know if you have clay-colored stools, dark urine, yellow eyes or skin, a fever, nausea, stomach pain, or loss of appetite.

The dose of Truvada PrEP is one tablet once a day. The average retail price for a one-month supply of medication is around $2,200. An FDA analysis in 2009 showed the average cost of generic drugs was approximately 80% to 85% less than brand name drugs, and the arrival of emtricitabine and tenofovir can offer significant savings.

How Does a Drug Become Generic?

Generic drugs play an essential role in our health care treatment options. Sixty-five percent of prescriptions in the United States are generics. They 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 generics is rigorous and well regulated by the Food and Drug Administration (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. 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.

Nicole Craven, MD is a fellowship-trained integrative medicine doctor, modern health content writer, editor, and holistic health educator. Trained by the AMWA and Nascent Medical to provide medical news, publications, CME, test preparation, white papers, and other scientific content. She focuses on natural wellness, products, and services that support the growth of a modern prevention-based health care system.

*Average pricing based on the following dosages:

Trvuada: 167-250 mg | 30 tablets

Pricing averaged at the following pharmacies: CVS Pharmacy, Walgreens Pharmacy, Walmart Pharmacy, Costco Pharmacy on June 18, 2020. Visit RxSaver.com to find your coupon prices in your area.