Generic Priftin (Rifapentine)
What we know:
The U.S. Food and Drug Administration approved the first generic formulation of Priftin (rifapentine) tablets on June 23. Following this announcement, NTCA initiated an inquiry with the FDA and Macleods Pharma LLC to clarify several key questions, including:
- Who is the manufacturer?
- Which distributors will carry the product?
- What is the NDC number, and what is the anticipated price point?
- When might TB programs expect the product to be available for procurement?
To date, NTCA has received partial information and answers to these initial questions. We have been in discussions with Macleods Pharmaceuticals, the manufacturer of the newly approved generic Priftin. While we didn't learn the NDC number or the anticipated price point, there is some good news emerging from these initial conversations:
- The product has arrived in the United States.
- Macleods Pharmaceuticals is currently working with distributors to make the formulation available on the market.
- The NDC number has not yet been assigned, but the potential release date is "sometime in September."
During our conversation, we emphasized that TB programs use a wide range of distributors nationwide and requested that they work with ALL distributors to ensure equitable access to this new generic rifapentine.
This is where your support is needed. Macleods Pharmaceuticals is asking TB programs to help facilitate market availability by contacting your usual distributor(s) to inquire about when they plan to carry the new formulation.
NTCA will continue engaging with the manufacturer to obtain additional details on the price point, anticipated release date, and any additional updates as they become available.
What we recommend:
Please reach out to your distributor(s) and request that generic Priftin be included in their inventory. Working directly with your distributor may help accelerate market availability.
If you have any questions, please feel free to contact Dr. Jasleen Gupta, the point of contact for Macleods Pharmaceuticals.
|