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TRALEMENT Drug Patent Profile

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 is one patent 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

Summary for TRALEMENT

International Patents:	6
US Patents:	1
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

See drug prices 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

Anatomical Therapeutic Chemical (ATC) Classes for TRALEMENT

A12CB	Zinc
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

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 one US patents and one FDA Regulatory Exclusivity.

Patents protecting TRALEMENT

FDA Regulatory Exclusivity protecting TRALEMENT

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			Y
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-001	Jul 2, 2020		RX	Yes	Yes
Am Regent	TRALEMENT	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-002	Dec 2, 2020		RX	Yes	Yes			Y

International Patents for TRALEMENT

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

Country	Patent Number	Title	Estimated Expiration
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
South Korea	20230058047	미량 원소 조성물, 그 제조 및 사용 방법
European Patent Office	4175615	COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
Australia	2021300384	Trace element compositions, methods of making and use
World Intellectual Property Organization (WIPO)	2022006426