SELENIOUS ACID Drug Patent Profile

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

Selenious Acid 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 SELENIOUS ACID is selenious acid. One supplier is listed for this compound. Additional details are available on the selenious acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Selenious Acid

A generic version of SELENIOUS ACID was approved as selenious acid by AM REGENT on April 30^th, 2019.

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Summary for SELENIOUS ACID

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	3
Patent Applications:	781
What excipients (inactive ingredients) are in SELENIOUS ACID?	SELENIOUS ACID excipients list
DailyMed Link:	SELENIOUS ACID at DailyMed

Drug patent expirations by year for SELENIOUS ACID

Recent Clinical Trials for SELENIOUS ACID

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

Sponsor	Phase
American Regent, Inc.	Phase 4
Shanghai Zhongshan Hospital	N/A
Shanghai Changzheng Hospital	N/A

See all SELENIOUS ACID clinical trials

Paragraph IV (Patent) Challenges for SELENIOUS ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SELENIOUS ACID	Intravenous Solution	selenious acid	600 mcg/10 mL	209379	11	2024-06-11

US Patents and Regulatory Information for SELENIOUS ACID

SELENIOUS ACID is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting SELENIOUS ACID

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FDA Regulatory Exclusivity protecting SELENIOUS ACID

NEW CHEMICAL ENTITY
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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	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-001	Apr 30, 2019		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 SELENIOUS ACID

See the table below for patents covering SELENIOUS ACID around the world.

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Country	Patent Number	Title	Estimated Expiration
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
China	116096423	微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)	⤷ 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
World Intellectual Property Organization (WIPO)	2022006426		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration