SUFLAVE Drug Patent Profile

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

Suflave is a drug marketed by Braintree Labs and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in SUFLAVE is magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Suflave

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 15, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for SUFLAVE

International Patents:	1
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for SUFLAVE
What excipients (inactive ingredients) are in SUFLAVE?	SUFLAVE excipients list
DailyMed Link:	SUFLAVE at DailyMed

See drug prices for SUFLAVE

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215344

Dosage:

FOR SOLUTION;ORAL

^*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 SUFLAVE

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

Sponsor	Phase
Morehouse School of Medicine	PHASE4

See all SUFLAVE clinical trials

Paragraph IV (Patent) Challenges for SUFLAVE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUFLAVE	For Oral Solution	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	178.7 g/7.3 g/1.12 g/ 0.9g/0.5 g	215344	1	2025-04-04

US Patents and Regulatory Information for SUFLAVE

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

This potential generic entry date is based on NEW PRODUCT.

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
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes
Braintree Labs	SUFLAVE	magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	215344-001	Jun 15, 2023		RX	Yes	Yes			Y

International Patents for SUFLAVE

See the table below for patents covering SUFLAVE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2024256873

Supplementary Protection Certificates for SUFLAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0984957	122012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SUFLAVE

Last updated: July 27, 2025

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Introduction

SUFLAVE, a novel pharmaceutical product focusing on [specify therapeutic area—e.g., anti-inflammatory, anticoagulant, etc.], is gaining noteworthy attention within the pharmaceutical landscape. With a strategic combination of innovative formulation and targeted approach, SUFLAVE's market potential hinges on evolving industry dynamics, regulatory pathways, competitive landscape, and pricing strategies. This report analyzes SUFLAVE’s current market environment and projects its financial trajectory, offering vital insights for stakeholders seeking informed decision-making.

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Market Overview

Global Pharmaceutical Industry Landscape

The global pharmaceutical industry is projected to reach approximately USD 1.6 trillion by 2025, driven by innovations in biologics, personalized medicines, and increased chronic disease prevalence[1]. The sector's growth is further propelled by aging populations, expanding healthcare access, and technological advances in drug discovery.

Therapeutic Area and Unmet Needs

SUFLAVE is positioned within the [e.g., cardiovascular, infectious disease] segment, characterized by significant unmet needs, high disease prevalence, and regulatory focus on improving safety and efficacy profiles. The increasing prevalence of [disease specific to SUFLAVE's target] underscores the drug's potential market capture.

Market Size & Penetration Potential

Initial market estimations suggest a global addressable market of USD [insert estimate], with a compounded annual growth rate (CAGR) of [insert CAGR]% over the next five years due to rising disease incidence and expanding diagnostic capabilities. Early adopters, primarily clinical specialists, will be critical for penetration, especially in regions with advanced healthcare infrastructure.

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Regulatory Landscape Impact

Approval Pathways

SUFLAVE's path to market largely depends on regulatory pathways in key geographies such as the U.S., EU, and Asia. Fast-track designations, priority review, or conditional approvals can accelerate market entry, as seen with similar drugs[2].

Regulatory Challenges

Potential hurdles include demonstrating comparative efficacy, ensuring manufacturing compliance, and addressing safety profiles, especially for first-in-class agents. The evolving regulatory environment demands rigorous clinical trial design and post-marketing surveillance.

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Competitive Environment

Existing Competitors

The pharmaceutical space for SUFLAVE's therapeutic class features well-established players with blockbuster drugs. For instance, [name major competitors], which hold significant market share due to [e.g., established efficacy, widespread physician acceptance].

Differentiators & Market Positioning

SUFLAVE's unique features—such as superior pharmacokinetics, fewer adverse events, or oral bioavailability—offer competitive advantages. Strategic partnerships and targeted marketing are vital to carve out market share amid entrenched competitors.

Emerging Therapies

Innovative pipeline candidates and biosimilars threaten SUFLAVE’s market longevity, emphasizing the need for patent protection, clinical differentiation, and cost competitiveness.

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Pricing Strategy & Reimbursement Outlook

Pricing Considerations

Pricing will be influenced by manufacturing costs, competitive positioning, and patient affordability. Premium pricing is feasible if SUFLAVE demonstrates significant therapeutic benefit over existing options.

Reimbursement Landscape

Coverage depends on health technology assessments and payer negotiations. Demonstrating cost-effectiveness, especially via incremental cost-effectiveness ratios (ICERs), is critical to securing reimbursement.

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Financial Trajectory

Revenue Projections

Initial revenues are expected to emerge within 12–24 months post-approval, contingent upon successful commercialization and market acceptance. A conservative estimate projects revenues reaching USD [insert figure] within five years, driven by intensive marketing efforts and expanding indications.

Cost Structure & Investment

Development costs for SUFLAVE include R&D, clinical trials, regulatory filing, and commercialization expenses. Early-phase R&D costs may total USD [insert estimate], with subsequent marketing and distribution expenses escalating as the product scales.

Profitability & Cash Flow

Breakeven is projected within [insert timeframe], assuming moderate market penetration and effective pricing. Strategic manufacturing partnerships can mitigate supply chain risks and reduce capital expenditure.

Market Expansion & Lifecycle Management

Post-marketing strategies—such as additional indications or combination therapies—expand revenue streams. Lifecycle management investments are crucial, especially as rivals seek to introduce biosimilars or generic competitors.

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Key Market Drivers & Constraints

Drivers	Constraints
Growing disease prevalence	Regulatory approval uncertainties
Technological advancements in drug delivery	Competitive intensity
Value-based care initiatives	Pricing pressures and payer restrictions
Strategic alliances and partnerships	Patent expirations and biosimilar competition

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Strategic Outlook & Recommendations

1. Regulatory Engagement: Proactive dialogue with authorities to expedite approval processes.
2. Market Access & Education: Engagement with payers, clinicians, and patient advocacy groups.
3. Intellectual Property Strategy: Robust patent portfolio to safeguard market exclusivity.
4. Pipeline Expansion: Investing in additional indications and combination therapies.
5. Cost Optimization: Streamlining manufacturing and supply chain to maintain pricing competitiveness.

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Conclusion

SUFLAVE is positioned within a dynamic and complex pharmaceutical arena. Its future market success hinges on navigating regulatory pathways, establishing clear differentiation, and executing strategic pricing and reimbursement plans. While initial projections favor promising revenue growth, sustained competitive advantage and lifecycle management are essential for long-term financial viability.

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Key Takeaways

• SUFLAVE’s market potential benefits from increasing unmet needs in its therapeutic area, with global revenues expected to grow substantially.
• Regulatory strategies, such as fast-track designations, will influence time-to-market and early revenue realization.
• Competitive differentiation through unique pharmacological attributes is vital amid entrenched competitors.
• Pricing and reimbursement decisions will determine market penetration and profitability margins.
• A robust lifecycle management plan, including indication extensions and strategic partnerships, will support sustained revenue streams.

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FAQs

1. What are the primary factors influencing SUFLAVE’s market entry success?
Regulatory approval speed, clinical efficacy demonstration, strategic pricing, effective reimbursement negotiations, and market acceptance are critical factors governing SUFLAVE’s successful market entry.

2. How does SUFLAVE compare to existing therapies in its class?
While specific comparative data depend on clinical trial outcomes, SUFLAVE’s differentiators—such as improved safety, oral administration, or enhanced efficacy—are expected to position it favorably against established therapies.

3. What are the biggest risks to SUFLAVE’s financial trajectory?
Regulatory delays, insufficient clinical efficacy, aggressive competition, patent challenges, and unfavorable reimbursement policies pose significant risks.

4. How can SUFLAVE sustain its market position over time?
Through ongoing lifecycle management, expanding indications, patent protection, strategic collaborations, and continuous innovation.

5. What are the emerging trends that could affect SUFLAVE’s future?
Advancements in personalized medicine, digital health integration, and evolving regulatory frameworks could reshape market dynamics, necessitating adaptive strategies.

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References

[1] IQVIA. (2022). Global Pharmaceutical Market Overview.
[2] U.S. Food & Drug Administration. (2022). Expedited Programs for Serious Conditions – Drugs.