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NY M82336




May 15, 2006

CLA-2-29:RR:NC:2:238 M82336

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.99.4700; 3004.90.9110

Herbert J. Lynch, Esq.
Sullivan & Lynch, P.C.
Inner Tech Park
56 Roland Street, Suite 303
Boston, MA 02129-1223

RE: The tariff classification of Telbivudine (CAS-3424-98-4), imported in bulk and tablet forms, from Germany and other countries

Dear Mr. Lynch:

In your letter dated May 5, 2006, on behalf of your client, Idenix Pharmaceuticals, Inc., you requested a tariff classification ruling.

“Telbivudine” is the non-proprietary (generic) name for an investigational new drug that, according to information found on the World Wide Web

See www.clinicaltrials.gov., is currently being evaluated in Phase III clinical trials, in the U.S. and abroad, for use in the treatment of hepatitis, chronic hepatitis B, and cirrhosis. You indicate in your letter that registration of the name “Sibivo™” (which is not owned by your client), for use as Telbivudine’s proprietary (brand) name, is pending.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for Telbivudine, imported in bulk form, will be 2934.99.4700, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” The rate of duty will be 3.7 percent ad valorem At the present time, “Telbivudine” is not listed in the Pharmaceutical Appendix to the Tariff Schedule..

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for Telbivudine tablets (i.e., tablets containing Telbivudine as the active ingredient) will be 3004.90.9110, HTSUS, which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other.” The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at: www.fda.gov.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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