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Last Updated: February 23, 2024

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 is one patent 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:1
Tradenames:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:cupric sulfate; manganese sulfate; selenious acid; zinc sulfate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
Generic Entry Date for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

US Patents and Regulatory Information for cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Am Regent MULTRYS cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-003 Jun 30, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-001 Jul 2, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent TRALEMENT cupric sulfate; manganese sulfate; selenious acid; zinc sulfate SOLUTION;INTRAVENOUS 209376-002 Dec 2, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

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Express Scripts
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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.