SUFLAVE Drug Patent Profile

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

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

The generic ingredient in SUFLAVE is magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate. There is one drug master file entry for this compound. Two suppliers are 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 August 2, 2044. 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

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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

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 four US patents and one FDA Regulatory Exclusivity.

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

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
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331	C300615	Netherlands		PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220
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	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
0984957	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812

Last updated: July 29, 2026

SUFLAVE market dynamics and financial trajectory: sales trend, payer access, pricing, and launch-to-exclusivity risk

SUFLAVE (suflave; oral suflave? as marketed) has limited publicly trackable financial data in major market trackers, and the commercial trajectory depends on two constraints: (1) whether SUFLAVE is in an FDA-approved formulation with routine uptake or a niche use-case with restricted eligibility, and (2) how quickly payer formularies move after launch. With no verifiable public dataset for SUFLAVE’s revenue, prescriptions, or payer positioning at the time of this analysis, a complete market-dynamics and financial-trajectory profile cannot be produced without risking materially incorrect conclusions.

What is SUFLAVE’s FDA status and approval basis that drives market adoption?

SUFLAVE’s market adoption and early revenue pattern are determined by its FDA approval pathway (for example, NDA vs. ANDA reference reliance), whether it received orphan or priority designations, and the presence of label-restricted indications that constrain eligible patient volume. A reliable market-dynamics assessment also requires the exact active ingredient(s), dosage form(s), and strengths.

No verifiable FDA approval record for “SUFLAVE” sufficient to anchor an Orange Book status, launch timeline, and label-driven TAM estimate is available in the information provided here.

How does SUFLAVE’s indication and dosing regimen affect eligible patient volume?

A drug’s financial trajectory usually tracks to an indication’s incidence and a regimen’s dosing intensity. Without SUFLAVE’s validated label text (indication wording and dosing schedule), eligibility modeling would be speculative.

Does SUFLAVE have REMS, restrictions, or risk signals that slow payer coverage?

REMS requirements, boxed warnings, or postmarketing safety actions can slow formulary access and delay patient starts. No verified SUFLAVE REMS or safety-action record is provided.

What is the Orange Book status of SUFLAVE and how does that shape exclusivity economics?

For branded Rx products, exclusivity and patent estate structure determine the revenue window, generic/biosimilar launch risk, and time-to-parity pricing pressure. An Orange Book-derived view needs:

• application number(s),
• listed patents with expiration dates,
• exclusivity blocks (e.g., 5-year new chemical entity, 3-year new clinical investigation, method-of-use blocks, pediatric extensions),
• any Paragraph IV filings and litigation.

No Orange Book dataset for SUFLAVE is provided in the prompt.

When does SUFLAVE lose exclusivity, and what generic entry risks exist?

A generic entry risk timeline requires confirmed patent expiration dates and any ANDA Paragraph IV activity.

How many patents cover SUFLAVE’s formulations and methods of use?

A meaningful “how many patents” answer needs the exact patent list and assignment chain tied to SUFLAVE’s approved applications.

Which companies are challenging SUFLAVE and what patent litigation affects SUFLAVE generics?

Patent litigation between brand and generic filers drives the probability and timing of generic launch, affecting pricing, market share, and branded revenue. To assess litigation impact, this analysis requires:

• district court docket outcomes,
• settlement dates,
• “trigger” dates for allowable generic launch,
• any appellate timelines.

No SUFLAVE litigation identifiers or settlement terms are provided.

What Paragraph IV challenges have been filed against SUFLAVE?

A valid answer needs ANDA filer names, Paragraph IV notice dates, and the Orange Book patent(s) targeted.

How does SUFLAVE’s pricing and payer contracting shape its sales ramp?

Branded revenue trajectory typically hinges on net price and payer coverage:

• formulary tier placement,
• step edits and prior authorization,
• patient cost-share requirements,
• contracting outcomes with PBMs and large payers.

No confirmed acquisition/transaction pricing, ASP/NBRx trend proxies, or payer coverage data is included in the prompt.

What is SUFLAVE’s ASP trajectory and NBRx pattern after launch?

A financial trajectory requires a time series of ASP and prescriptions or a reliable market proxy. None is available in the provided information.

What discounts and rebates are typical for SUFLAVE’s payer segment?

No rebate ranges, wholesaler discount patterns, or contract benchmarks for SUFLAVE are provided.

What generic launch scenarios exist for SUFLAVE, and how fast could price erosion occur?

Generic timing and launch intensity depend on:

• patent expiry and “last to expire” dates,
• successful Paragraph IV outcomes,
• manufacturing/IP barriers,
• label-design-around success.

Without the SUFLAVE patent and exclusivity dataset, any launch scenario would be speculative.

Could SUFLAVE face “authorized generic” or multiple ANDA entrants?

A credible entrant-risk view needs filed ANDAs, likely approval timelines, and historical entry patterns for comparable products.

How does SUFLAVE compare with competing therapies in its class on market access and cost-effectiveness?

Competitive economics requires:

• comparable-of-use treatments and line-of-therapy context,
• payer preference logic,
• published pharmacoeconomic evidence,
• net cost after rebates for each competitor.

No competitor set or class context is provided, and SUFLAVE’s active ingredient is not confirmed here.

Key Takeaways

• A complete, non-speculative market-dynamics and financial-trajectory analysis for SUFLAVE cannot be produced from the information provided.
• Building an evidence-based trajectory requires verified FDA label details, Orange Book exclusivity/patent listings, and actual commercial data (sales, prescriptions, pricing, and payer positioning).

FAQs

1. What active ingredient and dosage forms does SUFLAVE use, and what is its FDA label?
2. What is SUFLAVE’s Orange Book listing and exclusivity end date?
3. Have any ANDAs filed Paragraph IV certifications against SUFLAVE, and when?
4. What is SUFLAVE’s net sales trend by quarter and its prescription trajectory?
5. Which payers place SUFLAVE on formulary and what prior authorization or step edits apply?

References

None.