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 30th, 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 |
Recent Clinical Trials for selenious acid
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
American Regent, Inc. | Phase 4 |
Shanghai Changzheng Hospital | N/A |
Shanghai Zhongshan Hospital | N/A |
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
Patent Number: ⤷ Sign Up
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FDA Regulatory Exclusivity protecting selenious acid
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ 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 | 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 | ||||
Am Regent | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 209379-001 | Apr 30, 2019 | 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 selenious acid
See the table below for patents covering selenious acid around the world.
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 |