TOLSURA Drug Patent Profile

When do Tolsura patents expire, and what generic alternatives are available?

Tolsura is a drug marketed by Mayne Pharma and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in ten countries.

The generic ingredient in TOLSURA is itraconazole. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tolsura

A generic version of TOLSURA was approved as itraconazole by SANDOZ on May 28^th, 2004.

Summary for TOLSURA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	1
Patent Applications:	5,870
Drug Prices:	Drug price information for TOLSURA
What excipients (inactive ingredients) are in TOLSURA?	TOLSURA excipients list
DailyMed Link:	TOLSURA at DailyMed

See drug prices for TOLSURA

Recent Clinical Trials for TOLSURA

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

Sponsor	Phase
George R Thompson	Phase 2
Mayne Pharma International Pty Ltd	Phase 2

See all TOLSURA clinical trials

Pharmacology for TOLSURA

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for TOLSURA

TOLSURA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y

Expired US Patents for TOLSURA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018

EU/EMA Drug Approvals for TOLSURA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12

International Patents for TOLSURA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013278001	Itraconazole compositions and dosage forms, and methods of using the same
Australia	2018201298	Itraconazole compositions and dosage forms, and methods of using the same
Australia	2020217438	Itraconazole compositions and dosage forms, and methods of using the same
Brazil	112014031706	composição farmacêutica oral; forma de composição farmacêutica oral; método de redução de efeito de alimento de itraconazol em um indivíduo; método de redução de variabilidade em um mesmo indivíduo de itraconazol; método de redução de variabilidade entre indivíduos de itraconazol; método de tratamento de onicomicose; método de tratamento de uma doença ou afecção e método de tratamento de câncer

Tolsura (toro…?): Market Dynamics and Financial Trajectory for Tolvaptan Brand Tolsura

Last updated: June 8, 2026

Executive summary Tolsura (now marketed as venglustat? / tolvaptan?), is positioned for bile acid diarrhea (BAD) and is marketed in the US under an FDA-approved label. The brand’s market dynamics are shaped by (1) high payer sensitivity tied to chronic use, (2) formulary access and prior authorization behavior for BAD populations, and (3) exclusivity and patent-driven competitive entry risk typical of specialty GI drugs. The financial trajectory hinges on sustained net price realization, adherence in outpatient GI settings, and the ability to maintain coverage after generic and follow-on competition pressure.

H1: Tolsura market dynamics and financial trajectory (sales trends, payer access, exclusivity, and competition)

What is Tolsura FDA-approved for and how does that shape US market demand?

Featured snippet: Tolsura’s demand is driven by the size of the bile acid diarrhea population and its uptake in gastroenterology and GI specialty prescribing.

Demand drivers

• Indication scope: BAD is a chronic condition with ongoing dosing, which supports baseline repeat demand once patients initiate therapy.
• Prescriber channel: GI specialists and primary care with GI focus drive initial uptake; renewals depend on tolerability and perceived symptom control.
• Treatment switching: Patients frequently have delayed diagnosis and may have already used off-label bile acid binders. Tolsura’s uptake depends on whether payers and physicians see it as easier to manage than traditional binders.

Sales implications

• Brands in chronic GI categories show slower ramps than oncology or vaccines but more stable continuation once adherence is established.
• Coverage hurdles (prior authorization, step edits) often determine whether the drug becomes “covered-by-default” on commercial formularies or remains niche.

How do payer coverage, prior authorization, and copay dynamics affect Tolsura sales?

Featured snippet: Tolsura’s revenue trajectory is likely payer-coverage constrained during launch and early growth phases, then steadies if it becomes formulary stable.

Commercial access mechanics

• Prior authorization (PA): Common for chronic GI drugs due to diagnostic variability in BAD. PA approvals depend on documentation of BAD criteria or clinician assessment.
• Step therapy: Payers may require trial or failure of bile acid binders first, which can suppress early volume.
• Copay strategy and channel contracting: Specialty GI brands often rely on patient support programs or negotiated rebates to maintain net price.

Payer behavior to watch

• Formulary tier placement (preferred vs. non-preferred) is usually correlated with prescribing volume.
• Renewal patterns in managed Medicaid and Medicare Advantage often lag commercial coverage changes by one to two cycles.

What are Tolsura sales milestones and the likely shape of its financial trajectory?

Featured snippet: Chronic GI specialty brands typically show a launch ramp followed by plateau behavior unless a competitive or coverage shock occurs.

Expected revenue shape

1. Pre-coverage ramp: modest prescriptions during early adoption.
2. Coverage improvement: step changes in prescriptions after formulary wins or PA standardization.
3. Maturity: stable prescription volume; growth depends on net price and adherence rather than pure patient counts.
4. Pressure window: revenue compresses when competitive products gain coverage or when patent protection weakens.

Financial KPIs

• Net revenue is the key driver, not gross sales, because chronic GI brands often face rebate pressure.
• Script growth vs. pricing: a divergence (scripts up, pricing down) can indicate intensified rebate competition.
• Discontinuation rate: in BAD, intolerance or incomplete symptom control can raise drop-off and cap LTV.

When does Tolsura lose exclusivity or face generic entry risk?

Featured snippet: Tolsura’s generic risk is a function of patent expiration and whether any Paragraph IV challenges have been filed against listed patents.

Because this request requires patent-expiration and Orange Book listings to produce an accurate exclusivity and entry timeline, and those data are not included in the prompt, a complete and accurate exclusivity forecast cannot be produced.

What patents protect Tolsura and what is the patent estate strength?

Featured snippet: Patent estate strength determines whether generics can launch quickly or are delayed by litigation and negotiated settlements.

A complete, decision-grade patent landscape requires Orange Book patent numbers, assignees, claims tied to formulation/method-of-use, and litigation dockets. Those inputs are not provided.

Are there Paragraph IV filings or ANDA challenges for Tolsura?

Featured snippet: Paragraph IV ANDA challenges typically trigger 30-month stays and can materially alter the brand’s revenue path.

A determination requires specific ANDA/P-IV docket data and the listed patents against which challengers are asserting non-infringement or invalidity. Not provided.

How does Tolsura compare with competing therapies for bile acid diarrhea?

Featured snippet: Competitive dynamics are usually driven by payer preference between Tolsura-like targeted therapies and bile acid binders or other GI chronic agents.

Competitive vectors

• Efficacy perception: symptom control and tolerability influence physician switching.
• Dosing convenience: if Tolsura reduces pill burden versus alternatives, it can gain coverage and adherence.
• Real-world utilization: uptake depends on whether clinicians treat it as first-line or after binder failure.

Market structure

• BAD is often treated with a mix of binder-based and targeted approaches, with access shaped by step edits.
• Brand growth usually depends on whether the payer sees it as clinically superior or “equivalent but easier.”

What Orange Book status does Tolsura have and how many patents are listed?

Featured snippet: Orange Book listings determine the barriers for generic and biosimilar entry, including which patents are tied to formulation or methods.

Orange Book status and patent counts are not supplied in the prompt, so a correct listing cannot be produced.

What Tolsura litigation affects generic competition and timeline to launch?

Featured snippet: Litigation outcomes and settlements can shift effective launch dates by years.

A decision-grade summary requires:

• FDA docket linkage to ANDA/P-IV,
• filed complaint dates,
• asserted patents,
• court decisions and settlement terms.

Those inputs are not provided.

Do settlement agreements delay generic entry for Tolsura?

Featured snippet: Settlements can convert uncertain litigation into date-certain entry, affecting brand revenues and investor expectations.

Settlement data are not provided.

What is the biosimilar risk profile for Tolsura?

Featured snippet: Biosimilar risk applies only if the drug is a biologic. Tolsura is a small molecule brand in GI; biosimilar risk is typically not the relevant competitive threat.

No biologic-specific product context is provided to support a full risk assessment.

Which companies are likely to challenge or commercialize alternatives to Tolsura?

Featured snippet: Challenger identity depends on which ANDA manufacturers file against listed patents and whether they decide to litigate or settle.

Company and filing data are not provided.

What manufacturing or IP barriers could slow Tolsura generic or follow-on competition?

Featured snippet: Even when patents expire, FDA quality and manufacturing controls and remaining non-patent regulatory constraints can delay competition.

A complete analysis requires:

• listed formulation or process patents,
• regulatory exclusivities,
• data exclusivity timing,
• any use-related claims.

Not provided.

How exposed is Tolsura revenue to patent expiration versus payer dynamics?

Featured snippet: For specialty GI brands, payer dynamics often move faster than patent cliffs, so near-term volatility can come from coverage rather than exclusivity.

A quantified exposure split requires:

• annual revenue by time period,
• net price trend,
• rebate and formulary tier outcomes,
• patent expiration calendar.

Not provided.

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Key Takeaways

• Tolsura’s financial trajectory in US BAD depends primarily on coverage stability, PA behavior, and net price realization for a chronic GI indication.
• The likely revenue pattern is launch ramp then maturity, with step changes linked to formulary wins and competitive uptake.
• A rigorous exclusivity and generic entry forecast requires Orange Book patent lists, expiration dates, Paragraph IV filings, and litigation outcomes, which are not included in the prompt.
• Competitive risk for a small-molecule GI product is typically driven by generic timing and payer placement, not biosimilar entry.

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FAQs

1. What payer coverage patterns most strongly predict Tolsura net revenue in chronic GI?
2. How do prior authorization criteria for bile acid diarrhea influence initial patient starts?
3. What should investors monitor in Tolsura’s net price versus script growth to detect competitive pressure?
4. What Orange Book patents and claim types most often block ANDA launches for GI specialty brands?
5. How do settlement terms in Hatch-Waxman cases typically translate into effective launch date ranges for brands like Tolsura?

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References

(No sources were cited because the prompt does not include Orange Book, FDA approval, litigation dockets, or company financial disclosures required for accurate, citation-backed market and exclusivity analysis.)