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Executive Summary

MEAD JOHNSON REQUEST FOR DESYREL(END ITALICS) TEN-YEAR NON-PATENT EXCLUSIVITY was denied by FDA in an Aug. 15 letter to the firm's attorney Alan Kaplan (D.C. firm Kleinfeld, Kaplan and Becker). Mead Johnson petitioned FDA in June to grant the exclusivity, contending that the actual approval date of Desyrel (trazodone HCI) was Feb. 1, 1983 -- the date FDA approved a supplemental labeling application -- rather than Dec. 24, 1981, the date FDA issued a letter granting approval of the drug "with the understanding. . .that final printed labeling ]would[ be promptly submitted and revised" as set forth in the letter "before the drug ]was[ marketed." Under the ANDA/patent law, an ANDA for a new chemical entity approved after Dec. 31, 1981 and before Sept. 25, 1984 cannot be made effective for 10 years from the date of approval of the pioneer application. Mead Johnson argued in its petition that because the labeling approval fell between Jan. 1, 1982 and Sept. 24, 1984, Desyrel should have a 10 year exclusive marketing period. Mead Johnson said the Dec. 24, 1981 letter from FDA "could at best be viewed as an 'approvable letter' or as a 'conditional' approval because it did not permit marketing until revised labeling was submitted," FDA stated. FDA asserted in denying the petition that its Dec. 24, 1981 letter "neither stated nor implied that marketing had to wait until FDA approved the revised labeling." The agency explained: "Such approval was not needed for marketing because the labeling revisions had already been agreed to by phone by both parties. FDA's letter of Dec. 24, 1981 was based on this telephone agreement. Thus, no additional agency action was necessary in order for Desyrel to be marketed." FDA further stated that the letter of Feb. 1, 1982 "clearly approves a labeling supplement to the previously approved NDA." In addition, FDA said Mead Johnson's Jan. 19, 1982 letter to the agency "acknowledges Dec. 24, 1981 as the approval date." Kleinfeid, Kaplan and Becker filed a similar petition on behalf of Norwich Eaton Aug. 19. The firm requested that Buprenex (buprenorphine HCI) injectable be given five additional years of patent protection. Norwich Eaton maintained that although an approval letter for the drug was sent to the company on Dec. 29, 1981, "there did not exist at that time FDA approved labeling under which the product could have been marketed." Therefore, the firm said the approval date is June 28, 1985, the date final package labeling for Buprenex was approved. Alternatively, Norwich Eaton said that "even if the Dec. 29, 1981 letter could be construed as full approval of the product and its labeling, the date of receipt of that letter, Jan. 8, 1982, is the earliest date on which such approval could be regarded as effective. Norwich Eaton requested FDA to rule on the petition by Sept. 15, 1985. The patent for buprenorphine HCI expires in March 1986.

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