Remimazolam besylate - Generic Drug Details
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What are the generic sources for remimazolam besylate and what is the scope of patent protection?
Remimazolam besylate
is the generic ingredient in one branded drug marketed by Acacia and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Remimazolam besylate has fifty-three patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for remimazolam besylate
| International Patents: | 53 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 18 |
| Clinical Trials: | 29 |
| Patent Applications: | 52 |
| What excipients (inactive ingredients) are in remimazolam besylate? | remimazolam besylate excipients list |
| DailyMed Link: | remimazolam besylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for remimazolam besylate
*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.
Recent Clinical Trials for remimazolam besylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tongji Hospital | Phase 4 |
| Zhihong LU | N/A |
| Seoul National University Hospital | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for remimazolam besylate
Paragraph IV (Patent) Challenges for REMIMAZOLAM BESYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BYFAVO | Powder for Injection | remimazolam besylate | 20 mg/vial | 212295 | 1 | 2024-10-07 |
US Patents and Regulatory Information for remimazolam besylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | 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 remimazolam besylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2081921 | ⤷ Sign Up | |
| Japan | 2013049690 | SALT OF SHORT-ACTING BENZODIAZEPINE AND POLYMORPHIC FORM THEREOF | ⤷ Sign Up |
| Portugal | 2637662 | ⤷ Sign Up | |
| South Korea | 20140000702 | DOSING REGIMEN FOR SEDATION WITH CNS 7056 (REMIMAZOLAM) | ⤷ Sign Up |
| Eurasian Patent Organization | 024926 | СХЕМА ПРИЕМА CNS 7056 (РЕМИМАЗОЛАМА) ДЛЯ ИНДУЦИРОВАНИЯ СЕДАЦИИ (DOSING REGIMEN FOR SEDATION WITH CNS 7056 (REMIMAZOLAM)) | ⤷ Sign Up |
| Germany | 602007009128 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
