The 1984 Hatch-Waxman Act created a 180-day period of exclusivity to generic companies as an incentive to challenge patents on brand name drugs. However, there is a concern that some brand pharmaceutical companies have been circumventing the intent of the Act by using delay tactics such as authorized generics (where the brand product is repackaged as a generic and marketed either through a subsidiary or third party).

Authorized generics can lead to delaying generic competition by discouraging generic companies from challenging weak and potentially unenforceable patents.  Now, Representative Jo Ann Emerson (R-MO), along with Rep. Marion Berry (D-AR), Dennis Moore (D-KS) and Zach Wamp (R-TN), have re-introducing H.R. 573, which would prohibit the marketing of an authorized generic during the 180-day generic exclusivity period following a patent challenge.

The Act would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. (Introduced in House).  The Act would amend Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) by adding at the end the following:

Prohibition of Authorized Generic Drugs-

(1) IN GENERAL- Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, direct or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.

(2) AUTHORIZED GENERIC DRUG- For purposes of this subsection, the term `authorized generic drug’–

(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; and

(B) does not include any drug to be marketed, sold, or distributed–

(i) by an entity eligible for exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or

(ii) after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).’.

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  1. While the bills addressed two aspects of circumventing the Hatch-Waxmann act namely Reverse Payments, and Authorized Generics, the are other unjustified means of delaying the generic entry. At the end of patent expiry, certain brand companies introduce minor modification of the original formulation, get approval from the agency, withdraw the original formulation from market, and file a petition with FDA that the generic formulation referencing the original formulation should no longer be approved. Hence, there would be substantial delay from the agency to conclude on the petition, during which time the monopoly is maintaine by the brand, as no generic was approved even after the expiry of the patent. Since the new formulation with minor change in formulation is patented, it would amount to extending the monopoly for several years !

  2. […] Bill Introduced to Prohibit the Marketing of Authorized Generic Drugs The 1984 Hatch-Waxman Act combined the 180-day duration of exclusivity… […]