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NY H89974




April 11, 2002

CLA-2-29:RR:NC:2:238 H89974

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.59.5300; 3004.90.9115

Mr. John C. O’Connor
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285

RE: The tariff classification of Pemetrexed Disodium Heptahydrate (CAS-357166-29-1), imported in bulk form, and ALIMTA® (pemetrexed injection), from Ireland

Dear Mr. O’Connor:

In your letter dated March 19, 2002, you requested a tariff classification ruling.

The first product, Pemetrexed Disodium Heptahydrate, is an investigational drug currently being evaluated, in FDA Phase III clinical trials, for use in the treatment of malignant pleural mesothelioma.

The second product, ALIMTA® (pemetrexed injection), is an injectable dosage form of Pemetrexed.

The applicable subheading for Pemetrexed Disodium Heptahydrate, imported in bulk form, will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” The rate of duty will be 6.5 percent ad valorem. For the record, we note that, while “Pemetrexed” is listed in Table 1 of the Pharmaceutical Appendix to the Tariff Schedule and the suffix “Disodium” is listed in Table 2 of the Pharmaceutical Appendix to the Tariff Schedule, the suffix “heptahydrate” is not listed in Table 2 of said appendix. Accordingly, pursuant to General Note 13, HTS, Pemetrexed Disodium Heptahydrate is not eligible for duty-free treatment at the present time.

The applicable subheading for ALIMTA® (pemetrexed injection), put up in dosage form, will be 3004.90.9115, HTS, 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: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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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