Taking Stock of FDA’s 180-Day Exclusivity Forfeiture Decisions – A Forfeiture Scorecard

By Kurt R. Karst –      

Now that we are a little more than six years after the December 8, 2003 enactment of Title XI of the Medicare Modernization Act (“MMA”), which, among other things, amended the FDC Act to create a new 180-day exclusivity regime for generic drugs – and as we patiently wait for FDA to issue proposed regulations to implement the forfeiture provisions, as well as a decision from the D.C. Circuit in the generic COZAAR/HYZAAR 180-day exclusivity litigation – we thought it would be a worthwhile exercise to take stock of the cases in which FDA has made a determination about 180-day exclusivity forfeiture. 

The MMA added six 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i).  Based on our research, FDA has made a total of 13 forfeiture decisions since 2003, with most (10) of those decisions concerning a first applicant’s failure to obtain tentative approval within 30 months of ANDA submission (FDC Act § 505(j)(5)(D)(i)(IV)).  However, we note that of these 10 decisions, 5 of them are so-called “punts” in which FDA did not make a formal forfeiture determination at the time of ANDA approval and stated it would do so only if another applicant becomes eligible for approval within 180 days after exclusivity is triggered.  None of these determinations were affected by a citizen petition.  (Congress clarified FDC Act § 505(j)(5)(D)(i)(IV) in the 2007 FDA Amendments Act, in which it provided that for an applicant eligible for 180-day exclusivity, if “approval of the application was delayed because of a petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates) . . . .” (FDC Act § 505(q)(1)(G)).)  In addition, there has been one case in which tentative approval was not obtained within 30 months of ANDA submission, but FDA determined that exclusivity was not forfeited because of a change in or review of ANDA approval requirements – ANDA No. 77-532 (Acarbose Tablets, 25 mg, 50 mg, and 100 mg); FDA Letter Decision (FDA ruled “that a change in bioequivalence requirements resulted in a delay in obtaining a tentative approval” and did not result in a forfeiture under FDC Act § 505(j)(5)(D)(i)(IV)).  In the Acarbose case, altough a citizen petition was submitted to FDA, because the petition was submitted after the date that was 30 months after ANDA submission, it did not implicate FDC Act § 505(q)(1)(G). 

Of the 3 remaining decisions, 2 of them (both litigated) are under the failure to market provisions (FDC Act § 505(j)(5)(D)(i)(I)) and one is under the withdrawal of application provision (FDC Act § 505(j)(5)(D)(i)(II)).  There do not appear to be any decisions with respect to 3 forfeiture provisions – amendment of certification (FDC Act § 505(j)(5)(D)(i)(III)), agreement with another applicant (FDC Act § 505(j)(5)(D)(i)(V)), expiration of all patents (FDC Act § 505(j)(5)(D)(i)(VI)).  The table below summarizes FDA’s forfeiture decisions by year and type.

Information on each of the 180-day exclusivity forfeiture decisions in the table above is provided below.

Failure to Market (FDC Act § 505(j)(5)(D)(i)(I)) – 

• ANDA No. 77-847 – Dorzolamide HCl, 2%; Timolol Maleate, 0.5%, Ophthalmic Solution (October 28, 2008); FDA Letter Decision

• ANDA No. 77-532 – Acarbose Tablets, 25 mg, 50 mg, and 100 mg (May 7, 2008); FDA Letter Decision

Withdrawal of Application (FDC Act § 505(j)(5)(D)(i)(II)) – 

• Guaifenesin Extended-Release Tablets, 600 mg and 1.2 gm (FDA Paragraph IV List notation added to June 15, 2009 list update)

Amendment of Certification (FDC Act § 505(j)(5)(D)(i)(III)) – None

Failure to Obtain Tentative Approval (FDC Act § 505(j)(5)(D)(i)(IV)) – 

Actual Forfeiture

• ANDA No. 77-461 – Nateglinide Tablets, 60 mg and 120 mg (September 9, 2009); FDA Letter Decision 

• ANDA No. 78-267 – Norethindrone Acetate, 0.02MG; Ethinyl Estradiol, 1 mg  (September 1, 2009)

• ANDA No. 77-170 – Cetirizine HCl, 5 mg; Pseudoephedrine HCl, 120 mg Extended-Release Tablets (February 25, 2008)

• ANDA No. 77-219 – Irinotecan HCl Injection, 20 mg/mL (February 20, 2008)

• ANDA No. 77-631 – Cetirizine HCl Chewable Tablets, 5 mg and 10 mg (January 11, 2008)

180-Day “Punt”

• ANDA No. 78-804 – Aspirin, 25 mg; Dipyridamole, 200 mg Extended-release Capsules (August 14, 2009)

• ANDA No. 78-104 – Triamcinolone Acetonide Nasal Spray, 0.055 mg (July 30, 2009)

• ANDA No. 78-115 – Carbamazepine Extended-Release Tablets, 100 mg, 200 mg, 400 mg) (March 31, 2009)

• ANDA No. 77-527 – Drospirenone, 3 mg; Ethinyl Estradiol, 0.03 mg Tablets (May 9, 2008)

• ANDA No. 76-969 – Metoprolol Succinate Extended-Release Tablets, 25 mg, 50 mg, 100 mg, 200 mg (July 31, 2006)

Agreement with Another Applicant, the Listed Drug Application Holder, or a Patent Owner (FDC Act § 505(j)(5)(D)(i)(V)) – None

Expiration of All Patents (FDC Act § 505(j)(5)(D)(i)(VI)) – None