Viewing data from:

PROVAYBLUE

NDA

METHYLENE BLUE | N204630 | PROVEPHARM SAS

2 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

Today

M-303

Jan. 8, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

7 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Amivas, Inc. FDA-2024-P-1913 · 6 docket documents Amivas, Inc. filed this citizen petition under 21 CFR 314.93 requesting permission to submit an ANDA for Methylene Blue Injection, USP (proposed name AMIVAS BLUE) at a strength of 50 mg/5 mL (10 mg/mL) for intravenous injection, which differs from the reference listed drug ProvayBlue® (NDA 204630) o	Suitability	2024-04-18	Granted	Amivas, Inc.
Suitability Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-0227 · 4 docket documents Zydus Pharmaceuticals (USA) Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting FDA approval to submit an Abbreviated New Drug Application for Methylene Blue Injection, USP, 5 mg/1 mL, a new strength of th	Suitability	2024-01-12	Granted	Zydus Pharmaceuticals (USA) Inc.
Citizen Petition from Zydus Pharmaceuticals (USA), Inc FDA-2023-P-5366 · 9 docket documents Zydus Pharmaceuticals (USA) Inc. filed this petition on December 6, 2023, requesting that the FDA investigate and take prompt enforcement actions against the unapproved Methylene Blue Injection manufactured by BPI labs and distributed by FFF. Zydus seeks removal of the unapproved product from the ma	Other	2023-12-07	Denied	Zydus Pharmaceuticals (USA), Inc
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2023-P-5387 · 7 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition on December 6, 2023, requesting that the FDA investigate and take prompt enforcement actions against unapproved methylene blue injection marketed by Cameron Pharmaceuticals and manufactured by Vitae Enim Vitae Scientific, Inc., alleging vi	Other	2023-12-07	Denied	Zydus Pharmaceuticals (USA) Inc.
Suitability Petition from Pharmobedient Consulting, LLC. FDA-2023-P-4288 · 4 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Methylene Blue Injection, 1% (10 mg/mL) suitable for submission in an Abbreviated New Drug Application, with the reference listed drug	Suitability	2023-10-03	Granted	Pharmobedient Consulting, LLC.
Suitability Petition Petition from Lachman Consultants Inc. FDA-2022-P-0200 · 6 docket documents Lachman Consultants Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Methylene Blue Injection, USP, 5 mg/1 mL suitable for submission as an ANDA, with PROVAYBLUE (methylene blue) injection USP 5 mg/mL as the r	Suitability	2022-02-18	Granted	Lachman Consultants Inc.
Citizen Petition from Kleinfeld Kaplan & Becker, LLP (Provepharm SAS) FDA-2017-P-6316 · 10 docket documents Provepharm SAS, represented by Kleinfeld Kaplan & Becker LLP, filed a citizen petition requesting that the FDA impose consistent safety standards on future applications for injectable methylene blue drug products to ensure they meet or exceed the safety profile of ProvayBlue (methylene blue injectio	505(q)	2017-11-02	Partially Denied	Kleinfeld Kaplan & Becker, LLP (Provepharm SAS)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

59 trials from ClinicalTrials.gov, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue NCT03120637	Phase 4	Completed	Institute of Liver and Biliary Sciences, India	111	2017-01-01 → 2018-01-10
Phase 2 Efficacy Study of Primaquine and Methylene Blue NCT02831023	Phase 2	Completed	University of California, San Francisco	80	2016-07 → 2017-01
Laparoscopic Tubal Patency Assessment NCT01725477	N/A	Completed	Pourmatroud, Elham, M.D.	30	2012-09 → 2015-03-09
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities NCT02240498	Phase 1	Completed	University of Rochester	21	2014-09 → 2023-09
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope NCT00314405	N/A	Completed	University Hospital, Strasbourg, France	100	2006-04 → 2008-04
Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity NCT01836094	Early Phase 1	Completed	The University of Texas Health Science Center at San Antonio	36	2013-08 → 2016-03
Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva NCT03200808	Phase 1	Completed	Maternal and Child Health Hospital of Hubei Province	118	2013-10-01 → 2019-10-17
Intraoperative Infusion of Methylene Blue for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery NCT04341844	N/A	Completed	Fudan University	248	2019-01-14 → 2020-07-30
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis NCT03379389	Phase 4	Completed	Fundação Educacional Serra dos Órgãos	284	2018-03-31 → 2021-06-01
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)NCT03469284	Phase 2	Completed	M.D. Anderson Cancer Center	69	2019-02-28 → 2022-02-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$317.39

Highest Price

$442.21

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00517-0374-05PROVAYBLUE (METHYLENE BLUE) 0.5% INJ	$442.21	FSS	American Regent, Inc.	09/28/2028
00517-0381-05PROVAYBLUE (METHYLENE BLUE) 0.5% INJ	$317.39	FSS	American Regent, Inc.	09/28/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

PROVEPHARM SASMETHYLENE BLUE

DMF 267352013

MIKROCHEM SPOL SROMETHYLENE BLUE

DMF 316942017

PHARMAZELL GMBHMETHYLENE BLUE USP

DMF 329002023

MACSEN DRUGSMETHYLENE BLUE USP

DMF 350952020

ICROM SRLMETHYLENE BLUE

DMF 363072021

CHEMCON GMBHMETHYLENE BLUE

DMF 363532022

CHEMWERTH INCMETHYLENE BLUE USP

DMF 366032022

SICHUAN QINGMU PHARMACEUTICAL CO LTDMETHYLENE BLUE

DMF 393412024

LUITPOLD PHARMACEUTICALS INCInactiveMETHYLENE BLUE INJECTION, USP 1%

DMF 152372000

ISO TEX DIAGNOSTICS INCInactiveMETHYLENE BLUE I-125

DMF 176842004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 3, 2024	SUPPL -26	View Letter (PDF)
Feb 7, 2024	SUPPL -23	View Letter (PDF)
Nov 7, 2023	SUPPL -22	View Letter (PDF)
Aug 23, 2022	SUPPL -18	View Letter (PDF)
Aug 19, 2022	SUPPL -18	View Letter (PDF)
Aug 9, 2022	SUPPL -16	View Letter (PDF)
Jul 5, 2022	SUPPL -8	View Letter (PDF)
May 28, 2021	SUPPL -11	View Letter (PDF)
May 24, 2021	SUPPL -10	View Letter (PDF)
May 24, 2018	SUPPL -6	View Letter (PDF)
Dec 29, 2017	SUPPL -5	View Letter (PDF)
Apr 12, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/10ML (5MG/ML)

RLDAP

0 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Apr 8, 2016

Exclusivities (1)

Code	Date	Status
M-303	Jan 8, 2027	< 1 year

#002 — 10MG/2ML (5MG/ML)

RLDAP

0 patents1 exclusivity▾

SOLUTION;INTRAVENOUS | Approved: Jul 18, 2019