Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate - Generic Drug Details

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What are the generic drug sources for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate and what is the scope of freedom to operate?

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate is the generic ingredient in two branded drugs marketed by Am Regent and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate has six patent family members in six countries.

One supplier is listed for this compound.

Summary for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

International Patents:	6
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate at DailyMed

Pharmacology for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

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 cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

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 CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

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 cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

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Glossary

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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	209376-002	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				⤷ Sign Up
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		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	209376-002	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	209376-002	Dec 2, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

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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
Canada	3186578	COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2022006426		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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