~ Buy the BLUDIGO (indigotindisulfonate sodium) Drug Profile, 2024 PDF Report in the Report Store ~

BLUDIGO Drug Patent Profile

Which patents cover Bludigo, and when can generic versions of Bludigo launch?

Bludigo is a drug marketed by Provepharm Sas and is included in one NDA. There are three patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in BLUDIGO is indigotindisulfonate sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indigotindisulfonate sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Bludigo

Bludigo will be eligible for patent challenges on July 8, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BLUDIGO

International Patents:	2
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	4,244
Drug Prices:	Drug price information for BLUDIGO
What excipients (inactive ingredients) are in BLUDIGO?	BLUDIGO excipients list
DailyMed Link:	BLUDIGO at DailyMed

See drug prices for BLUDIGO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BLUDIGO

Constraining patent/regulatory exclusivity:

10,927,258

NDA:

216264

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 BLUDIGO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Prove pharm	Phase 4

See all BLUDIGO clinical trials

Pharmacology for BLUDIGO

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for BLUDIGO

BLUDIGO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,927,258.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes	11,845,867			Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes	10,927,258			Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes	11,499,050			Y

International Patents for BLUDIGO

When does loss-of-exclusivity occur for BLUDIGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BLUDIGO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3559121	NOUVEAU PROCÉDÉ POUR LA PRÉPARATION D'INDIGOTINDISULFONATE DE SODIUM (CARMIN D'INDIGO) (NOVEL PROCESS FOR THE PREPARATION OF INDIGOTINDISULFONATE SODIUM (INDIGO CARMINE))
World Intellectual Property Organization (WIPO)	2018116325

BLUDIGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BLUDIGO

Introduction to BLUDIGO

BLUDIGO, developed by Provepharm, is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults. This product, known as indigotindisulfonate sodium injection, USP, has recently received FDA approval, marking a significant milestone for Provepharm and the medical field.

FDA Approval and Market Authorization

In July 2022, Provepharm announced that it had received FDA New Drug Approval for BLUDIGO, making it the first and only indigotindisulfonate sodium injection approved by the FDA[3][4].

• This approval is a testament to Provepharm's robust R&D strategy and its commitment to improving patient care and healthcare professionals' work.

Market Need and Indication

BLUDIGO is designed to aid in the visualization of the ureters during cystoscopic assessments, particularly following urological and gynecological surgical procedures. This fills a critical need in the medical field by providing a reliable diagnostic tool for ensuring the integrity of the ureters.

Competitive Landscape

As the first and only FDA-approved indigotindisulfonate sodium injection, BLUDIGO enters the market with a unique selling proposition. This lack of direct competition positions BLUDIGO as a leader in its niche, potentially capturing a significant market share in the diagnostic dye segment.

Provepharm's Strategic Expansion

Provepharm's success with BLUDIGO is part of its broader strategy to develop and market innovative pharmaceutical products. The company has previously achieved FDA approval for its injectable methylene blue product, ProvayBlue™, in 2016. This consistent success validates Provepharm's investment in R&D and its global expansion strategy[2].

Financial Implications

The approval and subsequent marketing of BLUDIGO are expected to have positive financial implications for Provepharm:

• Revenue Growth: With BLUDIGO being the second product to receive FDA approval, Provepharm can anticipate increased revenue from the US market, where it will be marketed directly by its US affiliate, Provepharm Inc.[4].
• Investment in R&D: The success of BLUDIGO reinforces Provepharm's strategy of investing heavily in research and development. This approach has already yielded significant returns, as seen in the company's ability to raise €120 million in 2021 to support its Horizon 2025 strategic plan[2].

Market Penetration and Sales

Provepharm's acquisition of Apollo Pharmaceuticals USA in 2020 has strengthened its presence in the US market, particularly in the segment of sterile injectable products. This strategic move is expected to facilitate the direct sales and distribution of BLUDIGO in the US, enhancing its market penetration[2].

Global Expansion

In addition to its US market presence, Provepharm has been expanding its operations globally. The company has recently launched direct sales in France and plans to extend its operations to the UK. This global expansion strategy is likely to increase the reach and sales of BLUDIGO, contributing to Provepharm's overall financial growth[2].

Industry Expert Insights

"BLUDIGO is the second product to be granted market authorization by the FDA from Provepharm's R&D group. This new success validates Provepharm's strategy based on a high level of investment in research and development aimed at improving patients' lives and healthcare professionals' work on a daily basis," said Frederick Girard, Provepharm's Chief Medical Officer[1][4].

Regulatory Environment

The FDA approval process is stringent, and the approval of BLUDIGO underscores Provepharm's ability to navigate this regulatory environment successfully. This approval also highlights the company's commitment to meeting the highest standards of safety and efficacy.

Future Outlook

Given the unique positioning of BLUDIGO in the market and Provepharm's strong track record in pharmaceutical development, the future outlook for this product is promising:

• Market Dominance: As the only FDA-approved indigotindisulfonate sodium injection, BLUDIGO is poised to dominate its market segment.
• Continuous Innovation: Provepharm's ongoing investment in R&D suggests that the company will continue to innovate and expand its product portfolio, further solidifying its market position.

Key Statistics

• FDA Approval Date: July 12, 2022[1][4].
• Previous FDA Approval: ProvayBlue™ in 2016[2].
• Financial Raise: €120 million in 2021[2].
• Acquisition: Apollo Pharmaceuticals USA in 2020[2].

Illustrative Quotes

"Provepharm is immensely proud of this accomplishment and approval by the FDA. We will soon make this important product available to clinicians in the US," said Mary Jane Helenek, Executive VP and COO of Provepharm, Inc.[3].

Conclusion

The market dynamics and financial trajectory for BLUDIGO are highly favorable. With its unique market position, strong regulatory approvals, and Provepharm's strategic expansion, BLUDIGO is set to make a significant impact in the diagnostic dye market and contribute substantially to Provepharm's financial growth.

Key Takeaways

• Unique Market Position: BLUDIGO is the first and only FDA-approved indigotindisulfonate sodium injection.
• Strong Regulatory Approval: Received FDA New Drug Approval in July 2022.
• Financial Growth: Expected to contribute significantly to Provepharm's revenue growth.
• Global Expansion: Part of Provepharm's broader strategy to expand globally.
• Continuous Innovation: Reflects Provepharm's ongoing investment in R&D.

FAQs

What is BLUDIGO used for?

BLUDIGO is a diagnostic dye used as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults, particularly following urological and gynecological surgical procedures[1][3].

When did BLUDIGO receive FDA approval?

BLUDIGO received FDA New Drug Approval on July 12, 2022[1][4].

What makes BLUDIGO unique in the market?

BLUDIGO is the first and only indigotindisulfonate sodium injection approved by the FDA, making it a unique product in its market segment[3][4].

How does BLUDIGO fit into Provepharm's overall strategy?

BLUDIGO is part of Provepharm's strategy to develop and market innovative pharmaceutical products, following the company's previous success with ProvayBlue™[2].

What are the financial implications of BLUDIGO's approval for Provepharm?

The approval of BLUDIGO is expected to increase revenue for Provepharm, particularly through direct sales in the US market, and reinforces the company's financial growth trajectory[2][4].

Sources

1. Provepharm - Provepharm receives FDA marketing approval in US for BLUDIGO (indigotindisulfonate sodium, USP) Injection.
2. Provepharm - Our History.
3. Provepharm - Provepharm receives FDA approval for BLUDIGO™ (indigotindisulfonate sodium, USP) Injection.
4. PR Newswire - Provepharm announces that it has received FDA approval for BLUDIGOTM (indigotindisulfonate sodium, USP) Injection.