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PROVAYBLUE Drug Profile
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When do Provayblue patents expire, and what generic alternatives are available?
Provayblue is a drug marketed by Provepharm Sas and is included in one NDA.
The generic ingredient in PROVAYBLUE is methylene blue. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylene blue profile page.
Summary for PROVAYBLUE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,988 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROVAYBLUE |
| DailyMed Link: | PROVAYBLUE at DailyMed |
Generic Entry Opportunity Date for PROVAYBLUE
Generic Entry Date for PROVAYBLUE*:
Constraining patent/regulatory exclusivity:
FOR TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA. 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 PROVAYBLUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Provepharm Life Solutions | Phase 2 |
| Carilion Clinic | Phase 2 |
Pharmacology for PROVAYBLUE
| Drug Class | Oxidation-Reduction Agent |
| Mechanism of Action | Oxidation-Reduction Activity |
US Patents and Regulatory Information for PROVAYBLUE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-002 | Jul 18, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-001 | Apr 8, 2016 | RX | Yes | Yes | 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 |
