CLA-2-29:OT:RR:NC:N3:138
Mark Pinchok
Bayer International Trade Services Corporation
243 Three Springs Drive, Suite 13
Weirton, WV 26062
RE: The tariff classification of Elinzanetant (CAS No. 929046-33-3) in bulk form and LYNKUET® (E
linzanetant) Capsules in dosage form, from Germany
Dear Mr. Pinchok:
In your letter dated January 5, 2026, you requested a tariff classification ruling.
Elinzanetant is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist that acts on the central
nervous system (CNS). It is indicated for the treatment of moderate to severe vasomotor symptoms (VMS;
also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer.
Lynkuet, imported in 60 mg capsule form, is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor
antagonist. It is indicated as an alternative to hormonal replacement therapy for women who cannot use
hormone-based treatments for the treatment of moderate to severe vasomotor symptoms, commonly known
as hot flashes, associated with menopause.
The applicable subheading for the Elinzanetant in bulk form will be 2934.99.3000, 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: Aromatic or modified aromatic: Other:
Drugs.” The general rate of duty will be 6.5 percent ad valorem. Currently, Elinzanetant is not listed in the
Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the Lynkuet capsules in dosage form will be 3004.90.9240, 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: Medicaments
primarily affecting the central nervous system: Other.” The general rate of duty will be free.
The duties cited above are current as of this ruling’s issuance. 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
at https://hts.usitc.gov/.
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 does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the
classification stated above, the merchandise covered by this ruling may also need to be reported with either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems Messaging Service (CSMS) messages at
https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division