PROVAYBLUE Drug Patent 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 2 |
| Patent Applications: | 6,892 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROVAYBLUE |
| What excipients (inactive ingredients) are in PROVAYBLUE? | PROVAYBLUE excipients list |
| DailyMed Link: | PROVAYBLUE at DailyMed |
Recent Clinical Trials for PROVAYBLUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Provepharm Life Solutions | Phase 2 |
| Carilion Clinic | Phase 2 |
| Provepharm SAS | Phase 4 |
Pharmacology for PROVAYBLUE
| Drug Class | Oxidation-Reduction Agent |
| Mechanism of Action | Oxidation-Reduction Activity |
US Patents and Regulatory Information for PROVAYBLUE
PROVAYBLUE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting PROVAYBLUE
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Try a Trial
FOR TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA.
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-002 | Jul 18, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-001 | Apr 8, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
