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 seven patents protecting this drug.

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

The generic ingredient in DURYSTA is bimatoprost. There are twelve drug master file entries for this compound. Fifteen 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 SANDOZ on May 5^th, 2015.

Summary for DURYSTA

International Patents:	179
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	1
Patent Applications:	5,606
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 seven 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	8,206,737
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	9,149,428		Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	7,799,336		Y
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	9,980,974

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	10,398,707
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020	8,673,341
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020	7,033,605

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
Austria	E397934
Australia	2005244203	Biodegradable intraocular implants containing prostamides
Australia	2007223057	Ocular therapy using sirtuin-activating agents
Australia	2011239642	Intraocular pressure reduction with intracameral bimatoprost implants

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	C300099	Netherlands		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308
0660716	02C0033	France		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:

DURYSTA (bimatoprost implant) Market Dynamics and Financial Trajectory: Pricing, Adoption, Competitive Pressure, and Monetization Outlook

Last updated: July 22, 2026

DURYSTA (bimatoprost ophthalmic implant) is generating revenue as an office-administered, longer-duration glaucoma therapy that competes against daily topical prostaglandin analogs and device-adjacent surgical care. Financial trajectory will be driven by (1) uptake by retina and glaucoma prescribers, (2) durability of real-world implant performance and retreatment cadence, (3) payer coverage and net pricing, (4) handling of safety and tolerability signals, and (5) competitive substitution from topical “once-daily” and “switch-to” strategies.

What drives DURYSTA market adoption versus daily glaucoma drops?

Core adoption thesis

• DURYSTA is a procedure-based ophthalmic product that trades patient adherence friction (daily dosing) for provider workflow and patient tolerance of local ocular procedure.
• Adoption expands when clinics standardize implant workflows, and when payers cover DURYSTA without meaningful out-of-pocket friction.

Where it wins

• Poor adherence or intolerance to daily prostaglandin analogs.
• Patient populations for whom long dosing horizons improve persistence.
• Practices that can integrate implantation into routine ophthalmology/retina/glaucoma visit schedules.

Where it loses

• Patients with strong adherence to established generics.
• Coverage tiers that force step therapy to low-cost topical therapy.
• Economics that do not pencil out for payers or provider networks if implant reimbursement lags acquisition cost.

How does DURYSTA pricing structure affect net revenue?

Market revenue is shaped by gross-to-net drivers:

• List price and payer discounts
• Contracting with commercial managed care and pharmacy benefit vs medical benefit channel mechanics
• Government pricing impacts if used in Medicare Advantage and fee-for-service settings

Commercial consequence Even with strong clinical differentiation, net revenue depends on whether DURYSTA is reimbursed in a manner that preserves margin for payer and provider. In ophthalmology, medical billing pathways and prior authorization requirements can materially slow adoption.

What role do retention and retreatment cadence play in sales?

For durability products, the economic model depends on:

• Median time to retreatment (or time to clinically meaningful IOP relapse prompting an implant repeat)
• Proportion of patients requiring repeat treatment during a given period
• Rate of discontinuation due to adverse events or poor tolerability

If real-world retreatment occurs later than planned, revenue per patient can be lower but total patient life-cycle value may still rise if adherence improves and fewer treatments are needed overall. If retreatment occurs earlier, the product resembles a higher-frequency procedural therapy, supporting faster revenue per cohort but raising safety and cost-of-care scrutiny.

When does DURYSTA lose exclusivity and what does that mean for revenue risk?

Exclusivity risk is a function of patent estate and regulatory exclusivity (if any), plus device/procedure-specific IP. For single-asset ophthalmic implants, revenue protection typically lasts until the last blocking patent expires and any formulation or method-of-treatment patents are no longer enforceable.

Revenue implication

• Prior to first generic/biosimilar-like substitution risk, the market can sustain premium pricing.
• After loss of exclusivity, pricing pressure and payer tightening become faster, especially if implant administration becomes commoditized.

What generic entry risks exist for DURYSTA?

Because DURYSTA is a drug-device combination delivered as an implant, “generic” entry depends on:

• Ability to replicate the implant formulation, release profile, and sterilized delivery system
• Demonstration of bioavailability or comparable exposure at the ocular tissue level (regulatory pathway dependent on FDA classification)
• Manufacturing controls for ocular implant sterility, dose uniformity, and release kinetics

Practical entry barrier Even where patent barriers fall, technical and regulatory requirements for ophthalmic implants can delay meaningful competition versus oral small molecules.

What is the competitive landscape for DURYSTA in glaucoma and ocular hypertension?

Competitive set

• Daily topical prostaglandin analogs (including generics)
• Combination drops that reduce the need for multi-drug adherence
• Laser procedures and surgical care (where appropriate)
• Other office-administered or implantable approaches in development (where available)

How does DURYSTA compare with prostaglandin analogs on economics and adherence?

Topical generics

• Lower acquisition cost per dose
• High patient adherence variability
• Low friction for prescribers because they align with standard prescribing patterns

DURYSTA

• Higher cost per episode
• Better adherence for persistence and longitudinal IOP control if durable
• Shifts care from chronic prescription refills to periodic clinic procedures

Net market effect DURYSTA tends to grow fastest where clinicians can identify patients with adherence failures or intolerance and where payer coverage is predictable.

How much of the glaucoma market is realistically “switchable”?

Switchability depends on:

• Proportion of patients inadequately controlled on topical therapy
• Rate of intolerance
• Patient willingness to undergo a procedure
• Access to ophthalmic centers that can administer the implant

The most addressable segment is patients who already cycle through multiple topical regimens or demonstrate poor target pressure control despite adherence support.

How do payer decisions and coverage policies shape DURYSTA financial trajectory?

Key payer levers

• Prior authorization requirements
• Coverage exclusions for mild disease stages
• Step therapy mandates to topical generics first
• Site-of-care reimbursement rules
• Net pricing through rebates and contracted discounts

Commercial consequence If DURYSTA is treated as a “specialty” ophthalmic product requiring prior authorization, uptake may lag clinical readiness. If coverage is broad and predictable, volume can rise quickly as physicians gain confidence in workflow and outcomes.

What does the DURYSTA revenue model look like across regions and channels?

DURYSTA’s financial trajectory is sensitive to:

• US vs ex-US adoption pace
• Commercial vs Medicare vs Medicaid mix
• Distribution channel and reimbursement framework (medical vs pharmacy billing)
• Clinic penetration and provider density for implant administration

US center of gravity For a novel ophthalmic product, US typically drives scale due to payer density and higher reimbursed volumes, while ex-US uptake depends on local reimbursement structures and regulatory approvals.

What safety and tolerability issues can impact sales and reimbursement?

Ophthalmic implant therapies are judged on:

• Ocular adverse events
• Need for additional interventions post-implant
• Dropout/discontinuation rates
• Impact on quality-of-life measures and clinical outcomes

Financial pathway

• Safety events can slow adoption through physician caution and payer edits.
• Retreatment or escalation to additional therapies can affect net per-patient lifetime value.

What financial milestones and growth markers matter for DURYSTA?

Investors and partners typically track:

• Prescription counts and implant procedures performed
• Patient persistence and retreatment intervals
• Net sales and gross-to-net evolution
• Contract wins with major payers or specialty pharmacy/medical administrators
• Expansion in approved indications or label-driven use cases (if applicable)
• Provider adoption metrics: number of active prescribers, clinics, and implant sites

Market dynamic For procedure-adjacent drugs, “active site growth” often leads “patient volume” by several quarters due to onboarding, training, and payer contracting cycles.

How do licensing, partnerships, and distribution contracts affect DURYSTA profitability?

For a prescription ophthalmic implant, profitability is influenced by:

• Manufacturing cost of the implant and delivery system
• Distribution agreements
• Commercial infrastructure costs (specialty contracting, prior auth support)
• Royalty structures tied to sales milestones

Deal mechanics that change trajectory

• Higher royalty rates or profit-sharing reduce realized margin even if top-line sales grow.
• Strong reimbursement support and contracted payer penetration can accelerate volume and reduce acquisition cost of sales (customer onboarding expense).

Key Takeaways

• DURYSTA’s sales growth depends on clinical durability translating into real-world retreatment cadence and on payer coverage enabling predictable net pricing.
• Adoption is constrained less by clinical efficacy and more by procedure logistics, prior authorization, and switching economics versus low-cost generic topical therapy.
• The main long-term revenue risk is exclusivity loss combined with technical/regulatory barriers to implant replication that can shape timing and degree of price pressure.
• Near-term financial trajectory hinges on procedure volume growth, active-site penetration, net pricing stability (gross-to-net), and safety-driven adoption restraint.

FAQs

1. How do prior authorization and step-therapy requirements typically affect adoption for implantable glaucoma therapies like DURYSTA?
2. What real-world retreatment intervals are most important for sustaining DURYSTA revenue per patient?
3. How should DURYSTA’s economics be compared with generic prostaglandin drops under payer and provider reimbursement models?
4. What factors determine whether DURYSTA faces delayed or faster competitive entry after exclusivity expiration for ophthalmic implants?
5. Which glaucoma subpopulations are most “switchable” from topical therapy to procedural implant therapy?

References

1. APA Style reference list is not available because no source documents or filings were provided in the prompt.