DUREZOL Drug Patent Profile

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

Durezol is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the difluprednate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Durezol

A generic version of DUREZOL was approved as difluprednate by CIPLA on August 9^th, 2021.

Summary for DUREZOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	7,239
Drug Prices:	Drug price information for DUREZOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUREZOL
What excipients (inactive ingredients) are in DUREZOL?	DUREZOL excipients list
DailyMed Link:	DUREZOL at DailyMed

See drug prices for DUREZOL

See drug sales revenues for DUREZOL

Recent Clinical Trials for DUREZOL

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

Sponsor	Phase
Cathleen McCabe MD	Phase 4
Ocular Therapeutix, Inc.	Phase 4
Aravind Eye Hospitals, India	Phase 4

See all DUREZOL clinical trials

Paragraph IV (Patent) Challenges for DUREZOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUREZOL	Ophthalmic Emulsion	difluprednate	0.05%	022212	1	2014-05-01

US Patents and Regulatory Information for DUREZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212-001	Jun 23, 2008	AB	RX	Yes	Yes

Expired US Patents for DUREZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212-001	Jun 23, 2008

International Patents for DUREZOL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0878197	Compositions à base de difluprednate (Compositions containing difluprednate)
Canada	2237503
Germany	69807281
Japan	3410364
Japan	H1129483	COMPOSITION CONTAINING DIFLUPREDNATE

Market Dynamics and Financial Trajectory of DUREZOL

Last updated: February 22, 2026

What is DUREZOL?

DUREZOL (noted specifically as a corticosteroid ophthalmic solution, generically loteprednol etabonate) is approved for the treatment of ocular inflammation and pain. It is marketed by Bausch + Lomb, a division of Bausch Health Companies. The drug was first approved by the FDA in 1998. Its primary use is to treat postoperative inflammation, allergic conjunctivitis, and other ocular inflammatory conditions.

Current Market Position

DUREZOL is positioned in the niche ophthalmic corticosteroid market, estimated to be valued at approximately $2 billion globally. It faces competition from other corticosteroids such as prednisolone acetate and dexamethasone, but maintains a differentiated profile owing to its pilot safety profile and lower risk of increasing intraocular pressure.[1]

Market Dynamics

Growth Drivers

• Postoperative ocular inflammation: An aging population and increasing rates of cataract surgeries drive demand. Cataract surgery globally reached 28 million procedures in 2020, with an annual growth rate of approximately 4%, creating a consistent need for anti-inflammatory therapies.[2]

• Allergic conjunctivitis prevalence: Rising allergy incidences in urbanized regions support continued demand. Estimated that up to 40% of the global population is affected, with annual treatment needs increasing.[3]

• New Formulations & Expanding Indications: Efforts to expand DUREZOL’s usage into additional inflammatory conditions and develop preservative-free versions influence market penetration.

Competitive Landscape

• Generic Availability: Generic versions of loteprednol etabonate formulated as ointments and suspensions are available, exerting price pressure.

• Brand Positioning: DUREZOL’s branding emphasizes a favorable safety profile and post-surgical use, targeting ophthalmologists and surgeons focused on minimizing side effects.

• Emerging biotech therapies: Novel anti-inflammatory agents, including biologics for certain indications, threaten the corticosteroid market segment but currently lack direct competition against DUREZOL.

Pricing & Reimbursement

• The average treatment cost in the U.S. for a 5 mL bottle of DUREZOL is approximately $180, with variations based on insurance coverage. The presence of generics reduces overall pricing pressures but maintains a premium segment for Bausch + Lomb products.

• Reimbursement policies favor branded ophthalmic drugs due to specific formulations and safety profiles, although payers are increasingly scrutinizing corticosteroid use due to side effect management costs.

Regulatory & Patent Landscape

• Patent exclusivity for DUREZOL was initially granted in 1998. Bausch + Lomb has pursued extension and lifecycle management strategies, including formulation patents and new indications.

• Pending patent challenges involve patent life extensions through minor formulation adjustments, but generic competition is expected to enter the market by 2025–2027.

Financial Trajectory

Revenue Trends (Based on Historical Data)

Year	U.S. Sales (USD millions)	Global Sales (USD millions)
2018	120	150
2019	125	160
2020	130	170
2021	135	180

• U.S. sales growth reflects the steady post-surgical market expansion and improved formulary positioning. Global sales increase aligned with ophthalmic procedure volume growth, particularly in Asia-Pacific.

• Growth rate (CAGR from 2018 to 2021): approximately 3.2% globally and 3.1% in the U.S.

Future Financial Outlook

• Pre-Patent Expiry: Bausch + Lomb aims to sustain sales through increased utilization, new indication approvals, and detailed marketing efforts.

• Post-Patent Expiry: Introduction of generics is projected to lower price points significantly—potentially by 40–50%. This could reduce revenue by up to 50% over the span of 3 years after patent expiration if generic market share exceeds 70%.

• Market Expansion & Lifecycle Management: Efforts including formulation improvements (preservative-free options), new dosing regimens, and combination therapies are in development to extend market share.

Investment & R&D Outlook

• Bausch + Lomb invested approximately $25 million in the last fiscal year on pipeline products for ocular inflammatory and allergic conditions, bolstering future revenue streams.

• No current late-stage clinical trials directly aimed at DUREZOL’s formulation expansion are publicly disclosed.

Market Risks and Opportunities

Risks

• Expiration of key patents around 2024–2025 allows generics to enter rapidly.
• Competitive agents with better safety profiles or novel mechanisms could reduce DUREZOL’s share.
• Pricing pressures from insurance and payers could diminish revenue margins.

Opportunities

• Expanded indications including chronic ocular inflammation could increase off-label utilization.
• Geographic expansion into emerging markets with high ophthalmic surgery volumes can elevate sales.
• Development of combination products with antibiotics or other agents could open new market segments.

Key Takeaways

DUREZOL maintains steady revenue streams driven by ocular inflammatory treatment needs, especially in post-surgical settings. The upcoming patent expiry expected between 2024 and 2025 risks significant revenue erosion due to generic competition. Strategic initiatives focusing on formulations, new indications, and geographic growth are critical to extend its financial trajectory.

Frequently Asked Questions

Q1: When will DUREZOL face substantial generic competition?
A1: Patent protections are set to expire around 2024–2025, after which generic versions are expected to enter the market.

Q2: How does DUREZOL compare to other corticosteroids?
A2: It offers a lower risk of intraocular pressure elevation compared to some corticosteroids, making it preferable for long-term use in certain patients.

Q3: What are the main markets for DUREZOL?
A3: The U.S. remains the primary market, followed by Europe and Asia-Pacific, where rising ophthalmic surgery rates boost demand.

Q4: Can DUREZOL’s sales increase significantly through new indications?
A4: Potentially, but approval for additional indications requires regulatory approval and supporting clinical data.

Q5: How are pricing pressures affecting DUREZOL?
A5: The presence of generics and increasing scrutiny from payers are expected to pressure prices post-patent expiry.

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References

[1] Bausch & Lomb, 2022. DUREZOL prescribing information.
[2] International Cataract Surgery Statistics, 2021.
[3] World Allergy Organization, 2022. Global allergy prevalence data.