SUCLEAR Drug Patent Profile

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

Suclear is a drug marketed by Braintree Labs and is included in one NDA.

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

Summary for SUCLEAR

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	SUCLEAR at DailyMed

US Patents and Regulatory Information for SUCLEAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braintree Labs	SUCLEAR	magnesium sulfate; polyethylene glycol 3350; potassium chloride; potassium sulfate; sodium bicarbonate; sodium chloride; sodium sulfate	SOLUTION;ORAL	203595-001	Jan 18, 2013		DISCN	Yes	No

Last updated: June 24, 2026

SUCLEAR drug market dynamics and financial trajectory (revenue, growth, pricing, and competitive pressure)

Executive summary

SUCLEAR’s market outlook is defined by (1) the timing of U.S. exclusivity and patent cliffs, (2) the speed and legal durability of first generic and authorized/at-risk entrants, and (3) payer and channel adoption driven by comparative clinical differentiation and total cost of therapy. SUCLEAR’s financial trajectory should be modeled through three phases: launch ramp, exclusivity-supported revenue build, and post-exclusivity erosion driven by paragraph IV litigation outcomes and interchangeability uptake.

What market dynamics shape SUCLEAR demand and pricing in the U.S. and Europe?

SUCLEAR’s demand and pricing power typically hinge on four variables that move quickly once competitive entry begins: payer coverage rules, formulary placement, pharmacy channel mix, and medical-need substitution.

1) Payer coverage and formulary tiering

High-impact drivers for SUCLEAR uptake:

• Positioning vs standard of care (SoC) in therapeutic guidelines and payer clinical criteria.
• Evidence depth for endpoints tied to coverage policies (response durability, relapse reduction, hospitalization avoidance).
• Step edits, prior authorization frequency, and copay card leakage (net sales dilution via patient pay mix).

2) Channel mix and distribution

Revenue resilience improves when SUCLEAR sustains:

• Prime wholesaler inventory health and stable sell-through (reduces rebate volatility).
• Specialty pharmacy conversion and adherence programs that reduce discontinuation.
• Reduced channel stuffing risk, which can otherwise distort reported net sales during launch and near expiry.

3) Pricing dynamics

SUCLEAR’s pricing trajectory generally follows:

• Initial acquisition of formulary access through contracting discounts.
• Mid-cycle price optimization based on realized net price trends and competitor price benchmarking.
• Post-generic pressure driving either gross-to-net deterioration (more rebates) or net price stabilization if substitution barriers exist (e.g., dosing convenience or evidence-based switching limits).

4) Competitive landscape

SUCLEAR’s pricing and volume competition depends on whether near-term entrants are:

• “Same-molecule” generics (higher speed, margin compression).
• Authorized biologic-style substitutes (slower but still share-taking).
• Differentiated products (delivery system or formulation advantages can slow switching).

How do FDA pathway and exclusivity status determine SUCLEAR revenue duration?

SUCLEAR’s FDA exclusivity status controls the earliest dates when competitors can file and, depending on litigation outcomes, when they can launch.

What determines the earliest generic entry risk?

For small molecules, the generic entry pathway is typically accelerated by:

• Paragraph IV filings that trigger 30-month stays (if the first filer wins a settlement or retains exclusivity protections).
• Expired patents that remove Orange Book barriers.
• Expiration of regulatory exclusivity (five-year new chemical entity exclusivity and/or three-year exclusivity extensions for additional clinical studies, where applicable).

What drives the practical launch date?

The practical date for revenue erosion often differs from formal expiration due to:

• Settlement agreements that delay entry beyond the statutory window.
• Court rulings that narrow or invalidate key listed patents.
• Manufacturing and supply readiness by first filers and followers.

When does SUCLEAR lose exclusivity and how fast does revenue erode after the first generic launch?

SUCLEAR’s post-exclusivity revenue trajectory is usually steep in the first 6 to 18 months after launch, then flattens as share distribution stabilizes.

Typical erosion curve to model

Use this structure for financial forecasting:

• Months 0 to 3 after launch: limited volume capture until prescriptions convert and payer edits update.
• Months 3 to 9: strongest share shift driven by step therapy, formulary switching, and wholesaler price adjustments.
• Months 9 to 18: stabilization as remaining patients either discontinue or switch permanently.

Key modeling inputs

• First entrant launch timing and whether it is “at-risk.”
• Number of approved ANDAs and pace of multi-source competition.
• Relative dosing convenience and total daily cost vs SUCLEAR realized net price.
• Contracting leverage by payers after competitor availability.

What patents protect SUCLEAR and how strong is the estate against Paragraph IV challenges?

SUCLEAR’s patent estate quality determines whether revenue erosion is delayed, narrowed to certain presentations, or accelerated by early wins against key claims.

Patent estate components that matter financially

A defensible estate typically includes:

• Drug substance claims (core molecule protection).
• Drug product/formulation claims (release profile, polymorph, solid-state form, excipients).
• Method-of-use claims (therapeutic regimen, patient subset).
• Manufacturing method claims (process controls that can block generic approvals even when substance claims fall).

How patent strength translates to financial outcomes

• Strong, multiple-layer estates lead to multi-year settlement patterns and slower generic adoption.
• Thin estates or early adverse rulings create faster, larger market share losses.
• Formulation or method-of-use-only estates can limit entry to certain claims, producing partial erosions rather than full product substitution.

What is the Orange Book status of SUCLEAR and which listings are most likely to be challenged?

Orange Book listings usually include:

• Active ingredient (drug substance) patents.
• Drug product (formulation/composition) patents by dosage form.
• Method-of-use and related regimen patents.

Which Orange Book patents are most financially relevant

For revenue protection, focus on:

• Those with the latest expiration dates.
• Those that are central to ANDA design-around difficulty.
• Those that have survived prior litigation in the same technology family.

What SUCLEAR patent litigation affects generic launch timing and settlement payouts?

Paragraph IV litigation patterns drive the market calendar. SUCLEAR revenue forecasts should incorporate:

• First filer litigation milestones.
• Court schedules and stay eligibility windows.
• Settlement structures that can delay launch (often including “pay-for-delay” type terms in some jurisdictions, depending on final settlement form).

What to model from litigation

• Probability-weighted outcomes (win, partial win, settlement, or dismissal).
• Timeline shifts from settlement that extend effective exclusivity.
• Potential carve-outs by strength of asserted claims (e.g., only certain doses are blocked).

How does SUCLEAR compare with competing drugs in the same therapeutic area on market share risk?

SUCLEAR’s financial trajectory depends on competitive substitution likelihood.

Comparison framework

Evaluate:

• Therapeutic equivalence or clinical advantage (guideline placement and payer clinical criteria).
• Route of administration and dosing regimen convenience.
• Safety and tolerability profile that drives switching decisions.
• Real-world adherence impact.

Switching friction signals

• If SUCLEAR requires fewer administrations, switching friction rises and post-generic share loss can slow.
• If competitor products have superior patient experience or lower total cost, share loss accelerates.

Which companies are most likely to challenge SUCLEAR, and what does that imply for market timing?

The “first filer” and “next filers” are the primary determinants of the speed of erosion. Financial impact differs when:

• A single strong first filer launches early and pulls the market quickly.
• Multiple challengers launch in close succession, compressing price recovery.

Follower dynamics

Follower ANDAs frequently enter once:

• the first generic has de-risked regulatory approval and supply chain.
• key patent hurdles fall via court outcomes or settlements.

What formulations and dosage strengths are most at risk for generic entry?

Even when an active ingredient remains protected, entry can occur at the dose, form, or strength level.

Formulation-specific risks

Common ways generics can enter despite partial protection:

• Reformulating around a solid-state or polymorph claim.
• Switching excipients or manufacturing process if product claims are narrow.
• Pursuing only certain strengths that are not protected by the latest listed patents.

Net sales implications

• If only a subset of strengths enters, overall SUCLEAR erosion can be less severe.
• If all strengths are vulnerable, erosion is wider and faster.

What generic entry scenarios exist for SUCLEAR and how should forecasts be structured?

For revenue planning, use three scenarios tied to regulatory and patent events:

Scenario A: Delayed entry (settlement or litigation win)

• Revenue declines start later.
• Net price remains higher longer.
• Higher probability of gradual decline with slower share transfer.

Scenario B: Timely entry via valid generic approvals

• Revenue drops in year 1 post-entry.
• Gross-to-net pressure increases as rebates expand.

Scenario C: At-risk early entry

• Rapid competitive share capture.
• Higher litigation and recall risk management cost.
• Strongest near-term volume impact, but reversals possible if injunctions or adverse rulings occur.

What FDA regulatory milestones and manufacturing/IP barriers could slow SUCLEAR erosion?

Even if patents fall, practical entry depends on regulatory and operational readiness.

Regulatory constraints

• Label negotiations that influence prescriber confidence and payer acceptance.
• Post-approval changes that can slow inventory ramp.

Manufacturing and supply barriers

• Capability to match dissolution, bioequivalence, and stability.
• Supply continuity risk can limit how quickly competitors capture share.

How does SUCLEAR affect investor and licensing economics (royalty durability, NPV, and acquisition value)?

SUCLEAR’s financial trajectory also affects:

• Royalty cash flows under license and commercialization agreements.
• IP asset valuation during corporate transactions.
• Partner incentives for lifecycle management (reformulations, new indications, line extensions).

Licensing and lifecycle strategy

Lifecycle plays that can protect revenue include:

• New dosing regimen patents (method-of-use or regimen).
• Next-generation formulations (extended-release, improved stability).
• New indication filings that restart exclusivity where supported.

Key tables: market and financial trajectory structure for SUCLEAR

Because SUCLEAR’s financial trajectory is event-driven, the forecasting model is built around the following calendar components.

Table 1. Revenue forecast phases tied to exclusivity and entry

Phase	Timing driver	Commercial outcome	Modeling focus
Launch ramp	FDA approval timing; early access	Accelerating prescriptions and formulary uptake	Realized net price, retention, channel fill
Exclusivity build	Patent and regulatory barriers	Peak net sales potential	Rebate structure, payer penetration
First erosion wave	First generic launch after barriers fall	Rapid share and price decline	Share capture rate, net price compression
Multi-source stabilization	Additional entrants	Flatter erosion, margin compression	Wholesale pricing, contract normalization

Table 2. Patent and litigation event calendar (inputs for scenario weights)

Input	Why it matters	Financial effect
Earliest patent expiration date	Sets first legal entry window	Delays or accelerates erosion
Paragraph IV first filer count	Predicts launch speed	Impacts number of competitors at entry
Stay duration outcomes	Shifts launch timeline	Changes start of revenue decline
Settlement scope	Determines which presentations can enter	Partial vs full erosion

Key Takeaways

• SUCLEAR’s revenue trajectory is governed by exclusivity duration, then a fast post-entry erosion curve shaped by payer switching and multi-source competition.
• The financial calendar is dominated by Paragraph IV litigation timing and settlement outcomes, which can move effective launch dates by years.
• Patent estate strength determines whether erosion is partial (specific strengths or formulations) or broad (full product substitution).
• Forecasting should be scenario-based around first generic launch timing, number of entrants, and realized net price compression rather than relying on static pricing assumptions.

FAQs

1. How do payer step edits and prior authorization requirements change SUCLEAR net sales during early generic competition?
2. What settlement structures most strongly affect whether SUCLEAR competitors launch at-risk or wait for calendar dates?
3. Which Orange Book listing types (drug substance vs drug product vs method-of-use) most commonly determine SUCLEAR generic entry feasibility?
4. How should SUCLEAR revenue models incorporate wholesaler inventory corrections around exclusivity expiration?
5. What formulation-specific design-around strategies most often enable generics to enter despite ongoing SUCLEAR patent protection?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. “Drug Approval Reports.” U.S. Food and Drug Administration.
3. FDA. Guidance for Industry: Patent Listing Requirements and Related Forms. U.S. Food and Drug Administration.
4. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” U.S. Food and Drug Administration.