SELENIOUS ACID - Generic Drug Details
What are the generic drug sources for selenious acid and what is the scope of freedom to operate?
Selenious acid
is the generic ingredient in one branded drug marketed by Am Regent, Aspiro, Cipla, Emerge Bioscience, Fresenius Kabi Usa, Gland, Stira, Sun Pharm, and Zydus Pharms, and is included in nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for SELENIOUS ACID
| International Patents: | 6 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 3 |
| Patent Applications: | 6,113 |
| 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 Zhongshan Hospital | N/A |
| Shanghai Changzheng Hospital | N/A |
Generic filers with tentative approvals for SELENIOUS ACID
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 600MCG/10ML | INJECTION;SOLUTION |
| ⤷ Start Trial | ⤷ Start Trial | 60UG/1ML | INJECTION |
| ⤷ Start Trial | ⤷ Start Trial | 12UG/2ML | INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stira | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 218536-001 | Dec 31, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Am Regent | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 209379-003 | Aug 30, 2021 | AP | RX | Yes | Yes | 12,150,957 | ⤷ 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 | |||
| Cipla | SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 218661-001 | Jul 21, 2025 | DISCN | 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 | |||
| >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
| 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 | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
