Generic Exclusivity and ANDA information

[diana.papshev]

During the June 2009 Webinar (see more details here), the following questions were submitted, we’d like to open them for a general discussion in our community:

“Is there a listing of manufacturers that have filed for an ANDA (not under Paragraph IV) that can be viewed (with dates of ANDA submission) or is there a way to determine how or if generic exclusivity will be granted to a manufacturer(s) or if generic exclusivity will not be granted to anyone. When a Brand manufacturer settles out of court to allow a generic manufacturer to launch the Authorized Generic - does the authorized generic have a ' 6 month exclusivity period' prior to other manufacturers coming to the market?...

Is there a way to estimate the number of generic manufacturers seeking approval?”

[diana.papshev]

Unfortunately, there is no single source (that we know of) that would reveal the information on ANDA filers, primarily because the FDA is obligated to keep applicants’ data confidential.

However, the following are a few helpful tips:

o Although ANDA information is kept confidential, tentative/final approvals are in the public domain – they can be easily located through Drugs@FDA. This source can help identify how many generic products are ready to enter the market once patent protection issues are resolved (but it does not reveal how many additional ANDAs are being reviewed or which ones have paragraph III vs IV certifications)

o Filers of ANDAs with paragraph III certification are not eligible for market exclusivity, only those companies that are the first to file an ANDA with paragraph IV certification can receive 180-day market exclusivity (there are occasions when 2 companies are both first to file). Public domain resources can be used to find out which company(ies) would be eligible for exclusivity; however, this information would be available only after the FDA grants tentative or final approval status. The official source of this information are the FDA’s tentative/final approval letters which are issued to the ANDA filers; sometimes they are posted at Drugs@FDA (in a product's approval history). The other source of this information would be communications released by generic companies (press releases, investor communications, etc.) through their corporate websites. According to Business Insights the following is the list of top 10 generic companies: Sandoz (Novartis), Teva, Mylan, Ratiopharm, Apotex, Greenstone (Pfizer), Winthrop (Sanofi-Aventis), Watson, Bayer, Stada. Other important players include Ranbaxy, Dr. Reddy's, KV, Sun, etc.

o Since authorized generics do not enter the market through a separate drug application process, they are not eligible for market exclusivity (which can be granted only by the FDA). The timing of subsequent market entry of ANDA-based generics will depend on three factors: 1. outcome of patent litigation with other generics, 2. expiration date of challenged patents, and 3. FDA review/approval status. This year, the FDA began reporting the list of authorized generics; however, this it is updated only on a quarterly basis and it does not reliably capture when authorized generics are discontinued.

[chantell.reagan]

Of note, the FDA reports that "NDA holders will be required to submit information on their authorized generic drugs in annual reports to the FDA under a final rule that takes effect Jan. 25, 2010". FDA will be required to update the list on a quarterly basis.

Source: FDA news 7/09