Remimazolam besylate - Generic Drug Details
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What are the generic drug sources for remimazolam besylate and what is the scope of freedom to operate?
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: | 23 |
| 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
Generic Entry Date for remimazolam besylate*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*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 |
|---|---|
| Pusan National University Yangsan Hospital | N/A |
| Tongji Hospital | N/A |
| Samsung Medical Center | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for remimazolam besylate
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 remimazolam besylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2352360 | ⤷ Try a Trial | |
| Russian Federation | 2470935 | БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ (SHORT-TERM ACTION BENZODIAZEPINE SALTS AND POLYMORPHS THEREOF) | ⤷ Try a Trial |
| South Korea | 20150081370 | 속효형 벤조디아제핀 염 및 이의 중합체 형태 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) | ⤷ Try a Trial |
| Canada | 2657347 | SELS DE BENZODIAZEPINE ET LEURS FORMES POLYMORPHES A ACTION BREVE (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
