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MIDAZOLAM IN 0.9% SODIUM CHLORIDE Drug Patent Profile
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Which patents cover Midazolam In 0.9% Sodium Chloride, and what generic alternatives are available?
Midazolam In 0.9% Sodium Chloride is a drug marketed by Inforlife and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in MIDAZOLAM IN 0.9% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the midazolam profile page.
DrugPatentWatch® Generic Entry Outlook for Midazolam In 0.9% Sodium Chloride
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 20, 2038. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There is one tentative approval for the generic drug (midazolam), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1,209 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MIDAZOLAM IN 0.9% SODIUM CHLORIDE at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Generic Entry Date for MIDAZOLAM IN 0.9% SODIUM CHLORIDE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | N/A |
| United States Department of Defense | N/A |
| The Geneva Foundation | N/A |
Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| Drug Class | Benzodiazepine |
Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Paragraph IV (Patent) Challenges for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | midazolam | 211844 | 2021-09-29 |
US Patents and Regulatory Information for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inforlife | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 211844-001 | Mar 22, 2021 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Inforlife | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 211844-002 | Mar 22, 2021 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
