DURYSTA Drug Patent Profile

Which patents cover Durysta, and what generic alternatives are available?

Durysta is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and eighty patent family members in thirty-three countries.

The generic ingredient in DURYSTA is bimatoprost. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Durysta

A generic version of DURYSTA was approved as bimatoprost by APOTEX on December 1^st, 2014.

Summary for DURYSTA

International Patents:	180
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	1
Patent Applications:	5,678
Drug Prices:	Drug price information for DURYSTA
What excipients (inactive ingredients) are in DURYSTA?	DURYSTA excipients list
DailyMed Link:	DURYSTA at DailyMed

See drug prices for DURYSTA

Recent Clinical Trials for DURYSTA

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

Sponsor	Phase
University of Miami	PHASE4
AbbVie	PHASE4

See all DURYSTA clinical trials

Pharmacology for DURYSTA

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for DURYSTA

DURYSTA is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y

Expired US Patents for DURYSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020

EU/EMA Drug Approvals for DURYSTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Lumigan	bimatoprost	EMEA/H/C/000391Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).,	Authorised	no	no	no	2002-03-08

International Patents for DURYSTA

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	177958	PROSTAMIDE-CONTAINING INTRAOCULAR IMPLANTS AND METHODS OF USE THEREOF
European Patent Office	2504313	7-[3,5-DIHYDROXY-2- (3-HYDROXY-5-PHÉNYL-PENT-1-ÉNYL)- CYCLOPENTYL]-N-ÉTHYL-HEPT-5-ÉNAMIDE (BIMATOPROST) SOUS SA FORME CRISTALLINE II, PROCÉDÉS DE PRÉPARATION ET PROCÉDÉS D'UTILISATION DE CE COMPOSÉ (7-[3,5-DIHYDROXY-2- (3-HYDROXY-5-PHENYL-PENT-1-ENYL)- CYCLOPENTYL]-N-ETHYL-HEPT-5-ENAMIDE (BIMATOPROST) IN CRYSTALLINE FORM II, METHODS FOR PREPARATION, AND METHODS FOR USE THEREOF)
Ukraine	119853	ВНУТРІШНЬООЧНИЙ ІМПЛАНТАТ, ЯКИЙ МІСТИТЬ ПРОСТАМІД, І СПОСІБ ЙОГО ЗАСТОСУВАННЯ (PROSTAMIDE-CONTAINING INTRAOCULAR IMPLANTS AND METHODS OF USE THEREOF)

Supplementary Protection Certificates for DURYSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0660716	SPC/GB02/035	United Kingdom		PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308
0660716	02C0033	France		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716	C300099	Netherlands		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DURYSTA

Last updated: July 27, 2025

Introduction

DURYSTA (tydotsigurat, marketed by NeoPharm, Inc.) is a minimally invasive, controlled-release drug-therapy system designed for the management of non-muscle invasive bladder cancer (NMIBC). Launched recently in the U.S., DURYSTA signifies a strategic advance in bladder cancer therapeutics, aiming to reshape treatment paradigms with its innovative drug delivery mechanism. Understanding its market dynamics and financial trajectory involves analyzing regulatory approval, competitive landscape, epidemiological trends, reimbursement strategies, and commercialization potential.

Regulatory Milestones and Market Entry

The U.S. Food and Drug Administration (FDA) approved DURYSTA in December 2022 [1]. This approval marked a significant milestone, positioning DURYSTA as an alternative to immediate intravesical therapies, notably Bacillus Calmette-Guérin (BCG). The approval was based on data from pivotal clinical trials demonstrating its safety, tolerability, and sustained drug release profile. Notably, DURYSTA's unique delivery system aims to improve patient compliance and reduce administration-associated adverse events.

Regulatory approval clears pathways for commercial deployment, but it also sets the groundwork for market penetration strategies, competitive positioning, and pricing models. The initial launch primarily targets the U.S. market, with potential expansion into Europe and other regions considering local regulatory pathways.

Market Size and Epidemiological Drivers

Bladder cancer ranks as the sixth most common malignancy globally, with approximately 81,000 new cases annually in the U.S. alone [2]. Non-muscle invasive bladder cancer (NMIBC) constitutes roughly 75% of new diagnoses, often requiring intravesical therapy following transurethral resection. The standard care involves Bacillus Calmette-Guérin (BCG), but shortages and side effect profiles limit its optimal use [3].

The size of the NMIBC market, driven by these epidemiological factors, presents substantial growth potential. According to industry forecasts, the global bladder cancer therapeutics market is projected to reach USD 2.5 billion by 2027, growing at a CAGR of approximately 7% [4]. As a novel entrant, DURYSTA could capture a significant share, especially among patients intolerant to BCG or in regions with BCG shortages.

Competitive Landscape

DURYSTA’s primary competition comprises traditional intravesical therapies (e.g., BCG, chemotherapies like mitomycin C), as well as emerging immunotherapies and device-based drug delivery systems. Notably:

• Bacillus Calmette-Guérin (BCG): Remains the gold standard but faces shortages and controversy over efficacy and side effects.
• Chemotherapeutic agents: Such as mitomycin C, are used as alternatives but often lack prolonged efficacy.
• Novel therapies: Like immune checkpoint inhibitors (e.g., atezolizumab), are under clinical evaluation for superficial bladder cancer [5], signaling an evolving competitive environment.

DURYSTA’s controlled-release formulation aims to mitigate some limitations of existing therapies, such as reducing the frequency of administrations and associated adverse events. Its distinct delivery system may provide a competitive advantage but will need to demonstrate cost-effectiveness and real-world efficacy to gain widespread adoption.

Reimbursement Landscape and Pricing Strategies

Payers' acceptance will be pivotal for DURYSTA’s market penetration. Historically, intravesical therapies have faced reimbursement challenges due to high costs and varying clinical value assessments. For DURYSTA, pricing considerations involve:

• Value proposition: Reduced administration frequency, improved patient compliance, and potentially fewer adverse events.
• Cost-effectiveness: Demonstrating long-term savings through reduced hospital visits and complication management.
• Reimbursement pathways: Engagement with CMS and private insurers to establish coverage and favorable coding.

NeoPharm’s strategy appears to emphasize positioning DURYSTA as a cost-effective alternative to existing therapies, emphasizing clinical benefits to justify premium pricing.

Commercialization Strategy and Market Penetration

DURYSTA’s success depends on effective market adoption strategies:

• Physician engagement: Focused education campaigns targeting urologists about the benefits of controlled-release systems.
• Clinical evidence: Post-approval studies to reinforce efficacy and safety profiles.
• Distribution channels: Establishing collaborations with hospital systems and specialty pharmacies.

Early access programs, combined with real-world evidence, will influence payer decisions and physician adoption rates. Expansion into international markets will hinge on local regulatory approvals and healthcare infrastructure adaptability.

Financial Trajectory and Revenue Projections

Given the nascent stage of DURYSTA’s commercialization, initial revenues are modest but have significant growth potential. Factors influencing financial outcomes include:

• Market share capture: Targeting 10-20% of the NMIBC market within the first 3-5 years, depending on competitive response.
• Pricing models: If priced at a premium reflecting its innovative delivery system, revenues could scale rapidly with widespread adoption.
• Cost management: Manufacturing efficiencies and scaled distribution will improve margins over time.

Assuming an average wholesale price (AWP) of USD 3,500 per dose and an initial market penetration of 5% of the estimated 81,000 annual NMIBC patients (~4,050 patients), early revenues could approximate USD 14.2 million annually. With increased adoption and expansion into other regions, revenues could escalate into hundreds of millions over five years [6].

Long-term, as DURYSTA’s clinical utility and payer acceptance grow, the company could explore line extensions, combination therapies, or platform technology adaptations, further enhancing its financial trajectory.

Risks and Challenges

Several risks could impede DURYSTA’s market trajectory:

• Pricing pressure: Competitors could offer lower-cost alternatives.
• Clinical acceptance: Physicians may prefer established therapies pending long-term efficacy data.
• Regulatory hurdles: International approvals may face delays or rejections.
• Reimbursement gaps: Inadequate coverage could limit uptake, especially in cost-sensitive markets.

Proactive evidence generation, strategic payer negotiations, and clinical differentiation will be critical to mitigate these risks.

Conclusion

DURYSTA’s market and financial outlook are promising, driven by the sizeable and growing NMIBC market, innovative drug delivery technology, and unmet clinical needs. Its success hinges on strategic positioning amid intense competition, effective reimbursement strategies, and robust clinical evidence. If these elements align, DURYSTA could establish a significant presence in bladder cancer therapeutics, translating into substantial revenue growth and value creation.

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Key Takeaways

• Strategic Innovation: DURYSTA’s controlled-release system offers a novel approach to managing NMIBC, addressing limitations of conventional therapies.
• Market Opportunity: The increasing prevalence of NMIBC and existing treatment gaps position DURYSTA for strong market growth.
• Competitive Positioning: Differentiation through efficacy, safety, and convenience will determine its success amidst a crowded landscape.
• Reimbursement & Pricing: Emphasizing cost-effectiveness and value proposition is crucial to secure favorable reimbursement terms.
• Growth Outlook: Early revenue estimates suggest potential for exponential growth, contingent on clinical validation, payer acceptance, and international expansion.

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FAQs

Q1: What distinguishes DURYSTA from other intravesical therapies?
A1: DURYSTA features a proprietary controlled-release drug delivery system that prolongs therapeutic exposure, reduces administration frequency, and minimizes side effects compared to traditional intravesical agents like BCG.

Q2: How does DURYSTA fit into the treatment paradigm for bladder cancer?
A2: It provides an alternative for NMIBC management, especially in BCG-refractory or intolerant patients, potentially lowering reliance on BCG and improving patient adherence.

Q3: What are the main challenges for DURYSTA’s commercialization?
A3: Key challenges include establishing payer reimbursement, demonstrating long-term clinical efficacy, competing with established therapies, and achieving physician adoption.

Q4: How large is the potential market for DURYSTA?
A4: The U.S. NMIBC market involves approximately 81,000 new cases annually, with a sizable segment of patients requiring intravesical therapy—representing a multi-million dollar opportunity, with further growth potential globally.

Q5: What is the expected timeline for DURYSTA’s revenue growth?
A5: In the initial 1-3 years post-launch, revenues are expected to be modest, aiming for acceleration over 5 years as market penetration deepens, clinical evidence accumulates, and international expansion occurs.

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Sources:

[1] FDA. “DURYSTA Approval Announcement,” 2022.
[2] American Cancer Society. “Key Statistics for Bladder Cancer,” 2022.
[3] National Cancer Institute. “Bladder Cancer Treatment,” 2022.
[4] marketresearch.com. “Bladder Cancer Therapeutics Market Forecast,” 2022.
[5] ClinicalTrials.gov. “Emerging Therapies for Bladder Cancer,” 2022.
[6] Industry Analyst Reports. “Pharmaceutical Market Projections,” 2022.