~ 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 three patents protecting this drug and two Paragraph IV challenges.

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 are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for TRALEMENT?
What are the global sales for TRALEMENT?
What is Average Wholesale Price for TRALEMENT?

Summary for TRALEMENT

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
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

Recent Clinical Trials for TRALEMENT

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

Sponsor	Phase
American Regent, Inc.	Phase 4

See all TRALEMENT clinical trials

Pharmacology for TRALEMENT

Drug Class	Copper Absorption Inhibitor Paramagnetic Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity
Physiological Effect	Decreased Copper Ion Absorption

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
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	3	2023-11-14

US Patents and Regulatory Information for TRALEMENT

TRALEMENT is protected by three 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

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

FDA Regulatory Exclusivity protecting TRALEMENT

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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	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
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
>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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
South Korea	20230058047	미량 원소 조성물, 그 제조 및 사용 방법	⤷ Sign Up
Australia	2021300384	Trace element compositions, methods of making and use	⤷ Sign Up
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
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration