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, Aspiro, Cipla, Fresenius Kabi Usa, Gland, Kindos, Stira, Sun Pharm, and Zydus Pharms. and is included in nine NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in SELENIOUS ACID is selenious acid. There is one drug master file entry for this compound. Two suppliers are 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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Questions you can ask:
- What is the 5 year forecast for SELENIOUS ACID?
- What are the global sales for SELENIOUS ACID?
- What is Average Wholesale Price for SELENIOUS ACID?
Summary for SELENIOUS ACID
| US Patents: | 2 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 3 |
| Patent Applications: | 3,566 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SELENIOUS ACID |
| 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 two US patents.
| 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 | AP | RX | Yes | Yes | 12,150,957 | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Pharms | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219322-002 | Jun 30, 2026 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aspiro | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219633-001 | Jun 11, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Am Regent | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 209379-002 | Jan 25, 2021 | AP | RX | Yes | Yes | 11,998,565 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Gland | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219629-001 | Jul 8, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aspiro | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219633-002 | Jun 11, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 SELENIOUS ACID
See the table below for patents covering SELENIOUS ACID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2021300384 | ⤷ Start Trial | |
| Canada | 3186578 | ⤷ Start Trial | |
| China | 116096423 | ⤷ Start Trial | |
| European Patent Office | 4175615 | ⤷ Start Trial | |
| South Korea | 20230058047 | ⤷ Start Trial | |
| World Intellectual Property Organization (WIPO) | 2022006426 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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