SOLUPREP S Drug Patent Profile

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

Soluprep S is a drug marketed by Solventum and is included in one NDA.

The generic ingredient in SOLUPREP S is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

Summary for SOLUPREP S

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for SOLUPREP S

SOLUPREP S is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solventum	SOLUPREP S	chlorhexidine gluconate; isopropyl alcohol	SOLUTION;TOPICAL	208288-001	Aug 8, 2018		OTC	Yes	Yes

International Patents for SOLUPREP S

See the table below for patents covering SOLUPREP S around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2008347253	Antimicrobial compositions
Brazil	PI0819567	"composições antimicrobianas, método para aprimorar a adesão molhada do artigo adesivo médico e método para evitar ou tratar uma condição da pele de um mamífero
Canada	2711217	COMPOSITIONS ANTIMICROBIENNES (ANTIMICROBIAL COMPOSITIONS)
China	101951779	Antimicrobial compositions
China	107019686	抗微生物组合物 (Antimicrobial compositions)

Last updated: July 24, 2026

SOLUPREP S (sodium sulfate/potassium sulfate/magnesium sulfate?) investment scenario, sales drivers, and patent-led exclusivity risk

No sufficient, verifiable information is available in the prompt to identify the active ingredients, dosage form, FDA NDA/ANDA/BLA listing, Orange Book status, manufacturer, approval date, exclusivity end dates, or active patent estate for “SOLUPREP S.” Without those identifiers, a fundamentals and patent-led investment analysis cannot be produced without risking factual inaccuracy.

What is SOLUPREP S and who manufactures it?

No verifiable product identity, active ingredient(s), strength, dosage form, sponsor, or manufacturing site details are provided.

Which FDA application is SOLUPREP S tied to (NDA vs ANDA vs 505(b)(2))?

No FDA application number or label/manufacturer mapping is provided.

What therapeutic role does SOLUPREP S play (bowel prep vs other indications)?

No indication is provided.

What is the Orange Book status of SOLUPREP S?

No Orange Book listing details (NDA number, listed patents, patent use codes, expiration dates, exclusivity codes) are provided.

How many patents cover SOLUPREP S and what types are they (drug substance, drug product, method of use)?

No patent numbers or categories are provided.

When does SOLUPREP S lose exclusivity (patent expiration vs exclusivity end)?

No patent or exclusivity dates are provided.

When do SOLUPREP S patents expire and when can generics enter?

No expiration dates or exclusivity timelines are provided.

What are the key expiration anchors for generic timing (earliest filing carve-outs, pediatric exclusivity, 30-month stay)?

No relevant patent or regulatory litigation timeline is provided.

What patent litigation affects SOLUPREP S and what settlement outcomes matter for entry timing?

No court case numbers, defendants, Paragraph IV filings, or settlement terms are provided.

Which companies are challenging SOLUPREP S with Paragraph IV certifications?

No challengers or certifications are provided.

What generic entry risks exist for SOLUPREP S?

No Orange Book risk, legal status, or FDA approval/labeling details are provided.

How do formulation or manufacturing-process patents block generic development?

No process/formulation patents are provided.

How does SOLUPREP S compare with competing bowel-prep products on patent and commercial fundamentals?

No competitor list, market share, pricing, or patent timelines are provided.

Which brands compete head-to-head and where are their exclusivity cliffs?

No competitive set is provided.

What is SOLUPREP S’s revenue exposure and demand sensitivity in the bowel-prep market?

No pricing, unit volume, payer mix, volume trajectory, or reimbursement dynamics are provided.

What utilization drivers impact demand (colonoscopy volume, guideline shifts, hospital vs retail mix)?

No demand drivers specific to SOLUPREP S are provided.

How strong is the patent estate for SOLUPREP S?

No patent counts, remaining lives, family breadth, claim scope, or enforceability signals are provided.

Are there multiple patent families with staggered expirations (primary + continuation filings)?

No family data is provided.

What is the expected generic penetration path once exclusivity falls (authorized generics, OTC switch, retailer contracting)?

No market or contracting data is provided.

What formulations are protected by SOLUPREP S and what delivery systems or dosage strengths are covered?

No drug product/formulation patent details are provided.

Do patents cover sachets, flavorings, dosing regimens, or specific excipient blends?

No formulation claims are provided.

Biosimilar risk: does SOLUPREP S face biologic follow-on competition?

No evidence is provided that SOLUPREP S is a biologic.

FDA regulatory status for SOLUPREP S: what pathway and what milestones matter?

No NDA/ANDA/505(b)(2) pathway, approval date, or supplement history is provided.

Is SOLUPREP S listed with exclusivity codes or specific pediatric/conditional exclusivity marks?

No exclusivity codes are provided.

Investment scenario for SOLUPREP S: base case, upside, and downside linked to exclusivity and entry

No product identity, exclusivity timetable, patent litigation posture, or commercial performance data is provided, so scenario modeling cannot be grounded in facts.

Key Takeaways

• “SOLUPREP S” cannot be mapped to a specific FDA product, Orange Book listing, or patent estate from the information provided.
• Without active ingredient identification, NDA/ANDA linkage, and patent/exclusivity details, a fundamentals and patent-led investment analysis would be unreliable.

FAQs

1. How do Paragraph IV filings typically accelerate generic entry for FDA-listed bowel-prep products?
2. What patent categories most often survive generic challenges for oral bowel-prep drugs?
3. How do pediatric exclusivity and 505(q) labeling carve-outs affect exclusivity end dates?
4. What commercial signals (NDC growth, payer coverage, channel mix) precede bowel-prep market share gains?
5. How do settlement agreements structure “at-risk” launch windows for FDA-approved generics?

References

No sources were cited because no verifiable SOLUPREP S identifiers (FDA application, Orange Book listing, patent numbers, or litigation records) were provided.