Teva's Aug. 14 launch of the first generic version of Pfizer's blockbuster antidepressant Zoloft (sertraline) is nearly a month and a half after FDA's ANDA approval.

The generic company told "The Pink Sheet" DAILY that the launch was no different from any other of the company's products in that it was a complete launch intended to meet market demand.

Teva holds 180-day marketing exclusivity on the 25 mg, 50 mg, and 100 mg doses of the selective serotonin reuptake inhibitor. Following approval of its ANDA June 30, the company said that it anticipated launch in the "latter part of July" (¹ Also see "FDA Approves Teva’s Generic Zoloft" - Pink Sheet, 30 June, 2006.).

The delay was due to several factors, including various manufacturing and labeling issues, Teva explained during its second quarter earnings call.

"We hoped to launch and have all the product prepared for the kind of launch that we wanted at the end of July, and we're simply not there," North America CEO George Barrett said Aug. 8.

Teva's manufacturing challenges were related to the company's Cidra, Puerto Rico plant, which was acquired when Teva bought Ivax.

To reduce complexity at and minimize dependence on the site, Teva has shifted 20 products from Cidra to other plants and also temporarily discontinued several older products.

Labeling issues stemmed from Teva's receipt of final labeling only a day or two prior to approval. The company had to make alterations to the antidepressant "black box" class warning, including a new statement specifying that the product is not approved for pediatric major depressive disorder.

The generics company also said that the "delay was attributable to a late labeling change in the brand product, which required additional consideration and text adjustment by the FDA."

Teva also attributed part of the delay to its recent launch of generic Zocor (simvastatin), the company's largest launch ever (² Also see "Merck’s Discounted Zocor Has Had “Negligible Impact,” Teva Says" - Pink Sheet, 8 August, 2006.).

In response to Teva's announcement, Pfizer told "The Pink Sheet" DAILY that it launched an "authorized" generic through its Greenstone division the morning of Aug. 14.

Teva said that it "fully expects to compete" against Pfizer's generic (³ Also see "Pfizer Prepares For Zoloft Authorized Generic Entry Following Teva’s Launch" - Pink Sheet, 29 June, 2006.).

Using IMS data, Teva estimated that for the year ending June 2006, U.S. sales of Zoloft were approximately $3.1 bil. Based on this estimate, Pfizer may have made more than $300 mil. of Zoloft sales during the Teva launch delay.

-John Rancourt

Teva Launches First Generic Zoloft

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