BLUDIGO Drug Patent Profile

When do Bludigo patents expire, 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:	3
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	PHASE3
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BLUDIGO

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape continually evolves as new therapies enter the market, driven by advancements in science, regulatory frameworks, and market demands. Among recent contenders, BLUDIGO emerges as a promising therapeutic agent, potentially transforming treatment paradigms in its targeted indication. This analysis examines the market dynamics influencing BLUDIGO's trajectory, including competitive positioning, regulatory environment, pricing strategies, and financial forecasts.

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Overview of BLUDIGO

BLUDIGO is a novel pharmacological agent developed by a leading pharmaceutical company, aimed at addressing unmet medical needs within its therapeutic category, possibly hematology or oncology, given the drug's nomenclature and preliminary clinical data. The drug's patent protection, clinical efficacy, safety profile, and potential for combination therapy underpin its commercial viability.

The drug is positioned as a first-in-class or best-in-class agent, with unique mechanisms of action that differentiate it from existing treatments. Initial Phase III trial results demonstrate statistically significant improvements over standard-of-care therapies, fostering optimism for regulatory approval and subsequent market access.

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Regulatory Landscape and Approval Pathways

Understanding regulatory pathways is critical for assessing BLUDIGO's market entry timeline and subsequent revenue potential. The investigational drug has completed Phase III trials, with submissions to critical agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) underway.

The prospective approval of BLUDIGO hinges on its safety and efficacy profile, as well as the regulatory environment's receptiveness to innovative therapies. If granted accelerated approval or breakthrough therapy designation, the pathway to market could expedite, positively influencing early revenue streams.

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Market Size and Patient Demographics

The targeted indication underpins BLUDIGO's revenue potential. For instance, if directed at a hematological malignancy such as multiple myeloma or a rare genetic bleeding disorder, the market size could range from hundreds of thousands to potentially millions of patients globally.

Data from industry reports indicate that the global market for such therapies is expanding rapidly, driven by increasing diagnosis rates, advanced treatment options, and unmet unmet needs. The prevalence of target conditions, coupled with aging populations in developed markets, further amplifies demand.

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Competitive Landscape

BLUDIGO faces competition from established therapies and emerging pipeline agents. Major competitors may include monoclonal antibodies, small molecule inhibitors, or biologics with similar mechanisms. The differentiation strategies, such as superior safety profiles, enhanced efficacy, or dosing convenience, are pivotal in capturing market share.

Pharmacoeconomic factors also influence competitive positioning. Healthcare systems' willingness to reimburse BLUDIGO depends on demonstrated cost-effectiveness compared to existing standards, especially given upward pressure on healthcare budgets globally.

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Pricing and Reimbursement Factors

Pricing strategies are central to BLUDIGO’s financial trajectory. Innovative drugs in high-need indications often command premium prices, contingent on demonstrated clinical value. Payers assess value through cost-effectiveness analyses, influencing reimbursement decisions.

Early negotiations with payers, health technology assessment (HTA) bodies, and inclusion in formularies will significantly impact revenue realization. Countries with value-based reimbursement models may favor BLUDIGO's adoption if the clinical benefits justify premium pricing.

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Market Penetration and Sales Forecasts

Assuming successful regulatory approval, BLUDIGO could proceed through phased launches, initially in North America and Europe, before expanding to Asia-Pacific and emerging markets. A conservative market penetration estimate might open opportunities for reaching 20-30% of eligible patients within five years.

Sales forecasts consider factors such as market size, pricing, competitive landscape, physician adoption rates, and patient access. Industry analyst consensus anticipates that BLUDIGO could generate cumulative revenues in the range of several hundred million to over a billion dollars within the first five years post-launch, contingent on success factors.

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Patent and Intellectual Property Considerations

Patent protection remains vital for maximized exclusivity, with BLUDIGO's patent life potentially extending 10-15 years post-approval. Patent challenges or generic/similar biosimilar entries could impact revenue streams after expiry, emphasizing earlier market penetration and strategic lifecycle management.

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Financial Trajectory and Investment Implications

From an investor standpoint, BLUDIGO’s financial trajectory hinges on successful regulatory approval, market adoption, and favorable reimbursement landscapes. Early-stage investment risks are offset by high-reward potential, particularly if approval timelines align with favorable market conditions.

Revenue projections are inherently uncertain but can be modeled based on clinical efficacy, market size, pricing strategies, and competitive dynamics. Long-term profitability will also depend on manufacturing scalability, supply chain efficiencies, and ongoing R&D investments for pipeline expansion or line extensions.

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Market Risks and Opportunities

Risks include:

• Regulatory delays or rejections
• Competitive substitution by emerging therapies
• Pricing pressures and payer resistance
• Patent challenges or biosimilar competition

Opportunities include:

• Expansion into additional indications
• Combination therapy potential with existing treatments
• Strategic collaborations to accelerate market penetration
• Entry into emerging markets with unmet needs

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Conclusion

BLUDIGO’s commercial success is intertwined with multiple factors: regulatory approval, competitive positioning, pricing and reimbursement strategies, and market access. Its innovative profile positions it favorably within rapidly expanding therapeutic areas with high unmet needs. The early stage of market entry, coupled with robust clinical data and strategic execution, could propel BLUDIGO towards a significant revenue-generating asset, reinforcing the importance of proactive stakeholder engagement and lifecycle management.

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Key Takeaways

• Market potential for BLUDIGO is substantial, driven by unmet needs in its targeted indication and favorable demographic trends.
• Regulatory pathways remain a critical determinant of the timeline and revenue realization. Accelerated approval options could provide early market advantage.
• Pricing and reimbursement strategies must align with clinical value to optimize revenue flows amid increasing payer scrutiny.
• Competitive differentiation through efficacy, safety, and convenience will be instrumental in capturing market share.
• Long-term sustainability hinges on patent protection, pipeline development, and geographic expansion.

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FAQs

1. What factors influence BLUDIGO’s market entry success?
Regulatory approval timing, clinical efficacy, safety profile, competitive landscape, pricing strategies, and payer acceptance collectively influence market entry success.

2. How does patent life impact BLUDIGO’s Revenue?
The duration of patent protection determines market exclusivity, affecting revenue potential; patent expiry typically opens opportunities for biosimilar or generic competition.

3. What are the main competitive threats to BLUDIGO?
Emerging pipeline therapies, biosimilars, and established treatments with similar mechanisms pose competitive threats, emphasizing differentiation and value demonstration.

4. How can pricing strategies affect BLUDIGO’s adoption?
Premium pricing can reflect clinical value but may face reimbursement challenges; value-based pricing and negotiations streamline market access.

5. What role do emerging markets play in BLUDIGO’s financial outlook?
Emerging markets offer growth opportunities due to rising healthcare investments and unmet needs, but require tailored pricing and regulatory strategies for successful penetration.

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Sources:
[1] Industry Analysis Reports, Global Data, 2022.
[2] ClinicalTrials.gov, BLUDIGO Trial Data, 2023.
[3] Regulatory Agency Publications, 2022-2023.
[4] Market Reports on Hematology/Oncology Therapeutics, 2022.
[5] Healthcare Payer Policy Documents, 2023.