COSOPT Drug Patent Profile

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

Cosopt is a drug marketed by Thea Pharma and is included in two NDAs.

The generic ingredient in COSOPT is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cosopt

A generic version of COSOPT was approved as dorzolamide hydrochloride; timolol maleate by SANDOZ on November 6^th, 2008.

Summary for COSOPT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	36
Patent Applications:	494
Drug Prices:	Drug price information for COSOPT
What excipients (inactive ingredients) are in COSOPT?	COSOPT excipients list
DailyMed Link:	COSOPT at DailyMed

See drug prices for COSOPT

See drug sales revenues for COSOPT

Recent Clinical Trials for COSOPT

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

Sponsor	Phase
Sengi	PHASE4
Prairie Eye Center	PHASE4
Wills Eye	Phase 2/Phase 3

See all COSOPT clinical trials

Pharmacology for COSOPT

Drug Class	Carbonic Anhydrase Inhibitor beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Paragraph IV (Patent) Challenges for COSOPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COSOPT	Ophthalmic Solution	dorzolamide hydrochloride; timolol maleate	2%/0.5%	020869	1	2005-10-11

US Patents and Regulatory Information for COSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	AT1	RX	Yes	Yes
Thea Pharma	COSOPT PF	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202667-001	Feb 1, 2012	AT2	RX	Yes	Yes

Expired US Patents for COSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998

International Patents for COSOPT

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	3368	OPHTALMIC COMBINATIONS OF CARBONIC ANHYDRASE INHIBITORS AND B-BLOCKERS
Denmark	167874
World Intellectual Property Organization (WIPO)	8200096
Netherlands	990041
Germany	3879292
Canada	1192560	2-TRIFLUORO-(OU TRICHLORO-)-ACETYLIMINO-3-METHYL- D.SUP.2-1,3,4-THIADIAZOLINE-5-SULFONAMIDES UTILISES POUR REDUIRE LA PRESSION INTRAOCULAIRE (2-TRIFLUORO-(OR TRICHLORO-)-ACETYLIMINO-3-METHYL- D.SUP.2-1,3,4-THIADIAZOLINE-5-SULFONAMIDES USED FOR REDUCING INTRAOCULAR PRESSURE)

Supplementary Protection Certificates for COSOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	C990041	Netherlands		PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752	CA 2000 00002	Denmark
0509752	SPC/GB99/043	United Kingdom		PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0296879	96C0003	Belgium		PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219
0509752	2000C/001	Belgium		PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
0509752	49/1999	Austria		PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306

COSOPT (dorzolamide hydrochloride/timolol maleate): Market dynamics and financial trajectory

Last updated: April 26, 2026

What is COSOPT and how does its product profile shape demand?

COSOPT is a combination ophthalmic product: dorzolamide hydrochloride plus timolol maleate, dosed for reduction of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Its category placement matters for demand because it sits in the crowded, long-duration glaucoma-treatment market where patients typically remain on therapy for years and where switching is constrained by dosing schedules, tolerability, and insurance formularies.

Key product fact pattern

• Drug class: Ophthalmic antiglaucoma therapy (carbonic anhydrase inhibitor + beta blocker)
• Indication set: Open-angle glaucoma and ocular hypertension
• Commercial model: Chronic use, high formulary impact, frequent payer-driven substitution within classes

How does the competitive landscape influence COSOPT’s market dynamics?

COSOPT competes within glaucoma care across three levers: (1) dosing convenience, (2) tolerability and ocular surface effects, and (3) payer preference for branded vs. generic vs. fixed-dose combinations.

Main competitive forces

1. Fixed-dose combination substitution
   • COSOPT is itself a fixed-dose combination. In the U.S. market, ophthalmology frequently shifts among branded combinations and generic combinations depending on net price and formulary placement.
2. Therapy-class switching
   • Patients and prescribers can switch across mechanisms (beta blockers, prostaglandin analogs, alpha agonists, rho kinase inhibitors, carbonic anhydrase inhibitors). COSOPT typically competes for second-line and adjunct positions where IOP control is not met.
3. Generic pressure
   • Once the individual components and/or the combination formulation are available generically in the relevant markets, price erosion follows quickly. The market’s economics for ophthalmics magnify this because treatment is chronic and claim volume is steady.

Practical implications for market share

• COSOPT’s share is sensitive to formulary tiering and net price (rebates/contracting).
• Competitive headwinds persist where payers steer toward lower-cost equivalent formulations.
• Uptake is moderated by prescriber inertia and a need for demonstrated IOP control and tolerability at the patient level, but financial outcomes hinge on whether COSOPT remains a preferred option in payer contracts.

Where does COSOPT fit in the financial trajectory of its owning brands?

COSOPT’s financial trajectory is tied to two sequential phases: patent/brand exclusivity and post-exclusivity pricing compression. For business forecasting and investment screens, the key indicator is whether COSOPT remains protected from direct substitution in the target geography, and whether it retains a durable share position despite generic entry.

Revenue dynamics by phase

• Exclusivity phase: Brand value is protected. Pricing power exists but can still be competed away by alternative branded glaucoma combinations and prostaglandin-heavy formularies.
• Post-exclusivity phase: Generic or lower-priced equivalents drive net sales down as:
  • Payers shift to lower acquisition cost options.
  • Physicians reduce prescribing of higher-priced products when therapeutic effect is similar.
  • Patient out-of-pocket burden encourages step therapy.

What do we know about COSOPT’s market authorization footprint?

COSOPT is marketed for chronic IOP reduction in glaucoma settings. Authorization footprint impacts financial trajectory through:

• regulatory stability (long-term supply),
• ability to maintain product availability,
• and continuity for chronic patients (reducing abrupt demand shocks).

(Authorization and product details exist across major ophthalmic markets, but no specific region-by-region revenue disclosures are provided in the available dataset here.)

How do dosing, adherence, and tolerability drive unit demand?

For ophthalmic chronic therapy, the demand engine is adherence. COSOPT’s dosing format and patient experience affect adherence through:

• comfort upon instillation,
• ocular surface tolerance,
• consistency with other drops,
• and dosing schedule integration with prostaglandin or other agents.

Financial linkage

• Higher adherence tends to sustain persistence, lowering churn-driven revenue volatility.
• Poor tolerability drives discontinuation and substitution, accelerating demand loss after generic entry.

What are the likely price and margin outcomes from competition?

In glaucoma fixed-dose combinations, the post-generic environment typically compresses price and gross margin unless the product retains a niche position via contracting, channel support, or differentiation in patient subgroups.

Margin drivers

• list price vs net price compression from rebates and competitive contracting,
• manufacturing and supply scale,
• competition intensity in the same therapeutic class (especially prostaglandin-first treatment pathways).

Revenue drivers

• persistence (time on therapy),
• incidence of diagnosed glaucoma and ocular hypertension requiring long-term IOP control,
• and prescribing preference within the formulary.

What is the likely financial trajectory profile for COSOPT?

COSOPT’s trajectory is best modeled as a chronic base with step-down behavior around exclusivity transitions and competitive entry.

Trajectory pattern typically observed in ophthalmics

• Before direct substitution: relatively stable demand with modest share shifts from branded alternatives.
• At generic or equivalent entry: revenue step-down due to formulary substitution and rebate renegotiations.
• After stabilization: a lower plateau persists if the product remains on formularies or has a residual committed prescriber base.

Because fixed-dose combination products can retain residual value through contracting even post-exclusivity, COSOPT can settle at a reduced but non-zero sales level rather than disappearing.

How do payer strategies shape COSOPT net sales?

Payers typically manage glaucoma therapy with:

• step therapy (trial of preferred mechanisms first),
• formulary tiering,
• and automatic substitution toward lower-cost equivalents where clinically appropriate.

Net sales impact channels

• PBM formularies and pharmacy benefit management terms determine whether COSOPT stays in preferred tiers.
• Competitive bidding and rebate pressure reduce net price even if volume holds.
• Where COSOPT’s acquisition cost falls faster than competitors, it can regain some placement. Otherwise, share continues to drift.

What is COSOPT’s demand sensitivity versus pipeline and innovation cycles?

COSOPT is not a one-off acute therapy. Demand depends on the underlying treated population and treatment persistence. Pipeline innovation shifts demand at the margin by:

• pulling first-line therapy toward prostaglandin-dominant strategies,
• and offering newer adjuncts that may reduce reliance on beta-blocker-based combos.

However, the chronic nature of glaucoma care means that even new options often expand the therapeutic menu rather than fully replace all existing fixed-dose combinations immediately.

What can be inferred about near- to mid-term business outlook?

Given the structural realities of fixed-dose combination ophthalmics:

• near-term volume tends to be steadier than in acute categories,
• near- to mid-term revenue is more likely to be determined by price compression and payer placement,
• and profit trajectory depends on whether the manufacturer can maintain contracting power or operate at sufficient scale despite lower net prices.

A key underwriting point for investors and R&D strategists is that COSOPT’s economics likely resemble a mature franchise pattern: steady base volume with downward pricing pressure.

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Key Takeaways

• COSOPT’s demand is anchored in chronic glaucoma and ocular hypertension treatment, making volume more persistent than in short-duration therapeutics.
• Market dynamics are dominated by formulary management, fixed-dose combination competition, class-switching among glaucoma mechanisms, and generic substitution.
• COSOPT’s financial trajectory likely follows an exclusivity-to-post-exclusivity pattern, with a step-down in net revenue at substitution events and a stabilized lower plateau if payer placement persists.
• Payer contracting and net price compression are the primary levers determining profitability more than unit volatility.
• Near- to mid-term outlook is shaped by whether COSOPT retains preferred formulary status in a market increasingly oriented around preferred mechanisms and lower-cost equivalents.

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FAQs

1) Is COSOPT primarily affected by patient incidence growth or by prescribing and payer decisions?
Both matter, but net revenue is more sensitive to payer tiering, rebate structures, and substitution behavior in a chronic formulary-managed market.

2) Does fixed-dose combination status protect COSOPT from substitution?
It helps but does not eliminate risk. Competitors include other fixed combinations and lower-cost equivalents, and payer formularies can still steer prescribing away based on net price.

3) What drives discontinuation risk for COSOPT?
Tolerability and ocular comfort, dosing convenience relative to other regimens, and therapeutic effectiveness versus alternative mechanisms.

4) How does generic entry typically change the financial trajectory of ophthalmic combo products?
It generally causes a sharp net sales decline and gross margin compression, followed by a lower stable plateau if the product remains on formularies.

5) What is the best business metric to watch for COSOPT’s financial health?
Net sales (not list price) and formulary placement, because they capture rebate pressure and competitive substitution effects.

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References

[1] FDA. “COSOPT (dorzolamide hydrochloride and timolol maleate ophthalmic solution) prescribing information.” U.S. Food and Drug Administration.