FAQ

OVERVIEW

Below are just a few of the frequently asked questions we have gotten over the years from both our patients and our partners.

How to Get Zydus Products

Where can I find Zydus products?

Zydus’s generic products can be found across the country in most pharmacies, both in store as well as mail order. You can contact your nearest pharmacy to find out whether they have your prescribed medication available as a Zydus generic.

Can I buy my medication directly from Zydus?

Zydus does not sell its products directly to patients. Our products can only be purchased with a valid prescription through a licensed pharmacy.

Can I purchase Zydus products from Internet-based pharmacies?

When purchasing medication online, please make sure that the website is from a legitimate pharmacy that is staffed by state-licensed pharmacists that requires a valid prescription. Also ensure that the pharmacy has a valid physical US address and telephone number, as there are several non-legitimate online pharmacies on the Internet.

About Zydus Products

How do I find the expiration date on the Zydus label?

Please find a sample label below to help you find the expiration date on your Zydus-labeled product.

The medication I am taking gave me an unwanted reaction. How do I report it?

To report an adverse event, please call 877-993-8779 Prompt 2, email zydus@tmacmail.com, or fax 678-581-4401. Hours of operation are 9:00AM to 5:00PM EST Monday through Friday.

You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Where are Zydus’s products manufactured?

Many of Zydus’s products are manufactured in our facilities in India, but we also have manufacturing sites in the US. You can find out more about our manufacturing facilities here.

Does Zydus export its products?

Zydus does not export its products.

I have a question about a Zydus product. Where can I find more information?

Our website has a page for every Zydus product marketed today – if you search through our product pages, you may be able to get the answer you need. If you are still seeking additional information, please reach out to us directly so we can try to help .

 

How do I find information about the inactive ingredients for my specific generic medication?

Zydus lists the inactive ingredients found in each of its products within the Prescribing Information, which can be found on our website. You may also reach out to our Medical Affairs team to ask any questions you may have – 877-993-8779 Prompt 2 or zydus@tmacmail.com.

Pricing

Why are generic drugs cheaper than branded products?

In 2017, $265.1 billion was saved through the use of generics in the US. There are primarily two reasons generic drugs cost less to the consumer than brand drugs. The first is research and development costs. While generic manufacturers do incur research and development costs, they are not subject to the high development costs brand companies face because the safety and effectiveness of the drugs have already been established by the brand. Whereas the brand companies are starting from scratch, the generic companies only have to show bioequivalency to the brand. The second reason generic drugs provide cost savings is generic manufacturers do not spend nearly as much in advertising costs as brand companies. By the time a generic comes to market, the product is already known by physicians and the general public so that level of advertising is not needed.

1Association for Accessible Medicines. 2018 Generic Drug Access & Savings in the U.S. Updated 2018. https://accessiblemeds.org/sites/default/files/2018_aam_generic_drug_access_and_savings_report.pdf. Accessed January 25, 2019.

 

How can I find out how much a Zydus product costs?

While we are unable to comment specifically on the pricing dynamics of individual products, Zydus does not set the prices charged by pharmacies or control the prescription benefits offered by insurance companies.

Does Zydus offer a Patient Assistance Program?

Zydus does not offer Patient Assistance Programs for its generic products.

About Generics

What is a generic drug?

According to the FDA, “A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version.”

 

Why do generic drugs look different from brand products?

Often times, there are patents or other trademark laws preventing generic manufacturers from developing a product that looks identical to the brand in terms of size, shape, and color. While there can be similarities in appearance between the two, the generic product cannot match the brand exactly. Even though they may look different, generic products maintain the same safety and efficacy as the brand.

Are generic medications really as effective as the brand-equivalent?

In order to gain FDA approval, generic manufacturers must prove their product:

  • contains the same active ingredients as the brand
  • is identical in strength, dosage form, and route of administration
  • have the same indication as the brand
  • is bioequivalent to the brand
  • meets the same batch requirements for identity, strength, purity, and quality as the brand
  • is manufactured under the same standards of good manufacturing practice regulations that the FDA requires for brand products.

FDA. Generic Drugs: Questions & Answers. Updated June 4, 2018. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed January 25, 2019.

FDA. Generic Drugs: Questions & Answers. Updated June 4, 2018. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed January 25, 2019.

How are generic drugs approved?

In order to gain FDA approval, a generic manufacturer must first create a formulation that is comparable to the brand product and demonstrates its product is “pharmaceutically equivalent” to the brand. Once the manufacturer has sufficient data to show this, it must file an ANDA (abbreviated new drug application). This will then be reviewed by the FDA to ensure the generic product demonstrates the same safety and efficacy as the brand product. If there are any outstanding patents, a generic may be blocked from gaining final FDA approval until the patents expire, or a settlement is reached between the generic company and the brand company.

Where can I find more information about generics?

There are many resources that can help provide additional information about generic drugs. Your doctor, pharmacist, or other healthcare provider can help answer any questions you may have. Below are a couple other resources that you can use:

Association for Accessible Medicines

US Food and Drug Administration

4 FDA. FDA Fact Sheet – What’s Involved in Reviewing and Approving Generic Drug Applications?. Updated August 31, 2017. https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM510852.pdf. Accessed January 25, 2019.