You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 14, 2024

~ Buy the TRALEMENT (cupric sulfate; manganese sulfate; selenious acid; zinc sulfate) Drug Profile, 2024 PDF Report in the Report Store ~

TRALEMENT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Tralement, and when can generic versions of Tralement launch?

Tralement is a drug marketed by Am Regent and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in six countries.

The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Tralement

Tralement was eligible for patent challenges on April 30, 2023.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

Summary for TRALEMENT
International Patents:6
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
Formulation / Manufacturing:see details
Drug Prices: Drug price information for TRALEMENT
What excipients (inactive ingredients) are in TRALEMENT?TRALEMENT excipients list
DailyMed Link:TRALEMENT at DailyMed
Drug patent expirations by year for TRALEMENT
Drug Prices for TRALEMENT

See drug prices for TRALEMENT

Recent Clinical Trials for TRALEMENT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
American Regent, Inc.Phase 4

See all TRALEMENT clinical trials

Pharmacology for TRALEMENT
Paragraph IV (Patent) Challenges for TRALEMENT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRALEMENT Injection cupric sulfate; manganese sulfate; selenious acid; zinc sulfate 0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL) 209376 1 2023-11-16

US Patents and Regulatory Information for TRALEMENT

TRALEMENT is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting TRALEMENT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED

FDA Regulatory Exclusivity protecting TRALEMENT

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-002 Dec 2, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TRALEMENT

See the table below for patents covering TRALEMENT around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 4175615 COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) ⤷  Sign Up
Australia 2021300384 Trace element compositions, methods of making and use ⤷  Sign Up
South Korea 20230058047 미량 원소 조성물, 그 제조 및 사용 방법 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2022006426 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.