“Shared Exclusivity” Could Apply To Eight First-Time Generics, FDA Says

At least eight first-time ANDA approvals over the next two years could require a determination of whether 180-day "shared exclusivity" should be awarded, FDA says in a court filing.

The agency filed a motion Feb. 6 to stay a ruling that invalidates its policy of awarding shared exclusivity to multiple ANDA filers pending appeal.

FDA noted the potential impact on near-term generic approvals if the agency has to choose between the shared exclusivity and "one first applicant" approaches.

The agency's Office of Generic Drugs has estimated the number of products for which different ANDA applicants filed first Paragraph IV certifications against different patents.

"My staff has compiled a list of such drug products...that, based on the information currently available, we believe are most likely to require an exclusivity determination in the relatively near future," OGD Director Gary Buehler said in the court filing.

"We have also estimated the date of the first potential approval of an ANDA for each product," at which time exclusivity determinations are made. The agency based its projections on the expiration dates of the 30-month stays of approval for first-to-file ANDAs.

"We estimate that there will be at least one such approval/exclusivity determination in or close to each of the following months: January 2004, September 2004, January 2005, March 2005, June 2005, October 2005, November 2005, January 2006," Buehler stated.

"These decisions will, in all probability, result in further litigation because, in the generic drug arena, the economic consequences of certain agency decisions make litigation a virtual certainty," FDA said. "It is vital to have strong legal guidance, preferably a court of appeals decision, before FDA makes these upcoming exclusivity determinations."

A number of blockbuster drugs could face generic competition over the next few years.

For instance, Aventis is warning that if its Allegra patent defense is unsuccessful, fexofenadine generics could enter the market in early 2005 (¹ (Also see "Aventis Defense Against Sanofi: Strong Pipeline Or Irrational “Exubera-nce”?" - Pink Sheet, 9 Feb, 2004.), p. 22).

The agency is understood to be considering shared exclusivity for generic versions of Schering-Plough's Rebetol (ribavirin) (² (Also see "Ribavirin ANDAs Await Decision By FDA; Par, Roche Expect Launch In August" - Pink Sheet, 28 Jul, 2003.), p. 8).

The agency has said it will continue to award shared exclusivity "when applicable" while it appeals D.C. federal Judge Richard Roberts' decision overturning the award of shared exclusivity for generic paroxetine (GlaxoSmithKline's Paxil ) (³ (Also see "FDA Guidance On ANDA Antibundling Statute Expected In February" - Pink Sheet, 9 Feb, 2004.), p. 39).

Roberts ruled that TorPharm does not have to share exclusivity with Alphapharm, Sandoz or Ivax (⁴ (Also see "Paxil Generics On Hold After Court Rejects FDA “Shared Exclusivity” Policy" - Pink Sheet, 12 Jan, 2004.), p. 9).

TorPharm filed an ANDA for one of the eight first-time generics facing shared exclusivity over the next two years, FDA said.

The agency noted that Roberts' ruling has already raised questions about prior exclusivity awards.

"Only one week after this court's final order of Jan. 8, 2004, one applicant submitted a letter to the agency seeking reconsideration of a past exclusivity determination based on this court's order," FDA said.

The agency's award of first-to-file rights on gabapentin (Pfizer's Neurontin ) to Purepac could face a challenge now that a judge has directed that a "one first applicant" approach should be applied to exclusivity determinations (⁵ (Also see "Neurontin, Rebetol Generics Could Be Affected By “Shared Exclusivity” Ruling" - Pink Sheet, 12 Jan, 2004.), p. 7).

Buehler's court declaration outlines a number of "new policy determinations" FDA would have to make if it were to adopt a "one first applicant" approach.

"For example, if the first patent listed expires, would the applicant who filed the first Paragraph IV certification to that patent still be entitled to exclusivity?" Buehler asks.

"Alternatively, would the applicant who filed the first Paragraph IV certification on the second patent now be eligible, or would the right to exclusivity for that product simply be extinguished?"