COSOPT Drug Patent Profile

When do Cosopt patents expire, 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

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

International Patents for COSOPT

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

Country	Patent Number	Title	Estimated Expiration
Greece	74616
Israel	101537	OPHTHALMIC COMPOSITIONS COMPRISING COMBINATIONS OF A CARBONIC ANHYDRASE INHIBITOR AND A b-ADRENERGIC ANTAGONIST
Luxembourg	85264

Supplementary Protection Certificates for COSOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

COSOPT Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the market and regulatory status of COSOPT?

COSOPT (dorzolamide hydrochloride and timolol maleate) is an ophthalmic solution used to treat elevated intraocular pressure associated with glaucoma or ocular hypertension. It is approved by the U.S. Food and Drug Administration (FDA) since 1998 and marketed globally, including the U.S., Europe, and Asia.

The drug faces generic competition following patent expiration, which occurred around the early 2010s. Its primary patents, covering formulation and method of use, expired by 2012-2013, leading to multiple generics entering the market. Market share has shifted significantly toward generics, impacting revenue streams.

What are the current market dynamics for COSOPT?

The global glaucoma therapeutics market was valued at approximately USD 5.5 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% over the next five years. Cosopt accounted for an estimated 10-15% of the fixed-dose combination (FDC) segment before patent expiry. Post-patent, generic offerings have disrupted its market share.

Key generics include products from Teva, Mylan, and other major manufacturers. Market share loss for branded Cosopt was over 50% by 2015-16, based on sales data from IQVIA.

How do the fundamentals of Cosopt compare to competitors?

Metric	Cosopt (branded)	Generic Alternatives	Market Share (2022)	Revenue Impact (Estimated)
Patent status	Expired	Yes	Declining	Reduced by over 70% since 2012
Market dominance (pre-2012)	High	Low	>80%	Multi-hundred million USD annually (pre-expiry)
Cost differentiation	Higher pricing	Lower pricing	N/A	Price erosion margins, especially in generics-heavy markets

The overall market is driven by cost-sensitive healthcare systems, favoring generics. Branded COSOPT sales have declined sharply, with current revenues mostly from existing patents and limited niche use cases.

What are the investment considerations?

R&D pipeline and reformulation potential:

No current licensed reformulations or new indications for Cosopt exist. R&D efforts are focused on novel drugs targeting retinal neuroprotection and alternative mechanisms.

Patent landscape:

Expiration of the original patents and subsequent challenges have eroded exclusivity. Certain secondary patents related to manufacturing may still provide limited protection but are not significant enough to prevent rapid generic entry.

Manufacturing and supply:

The manufacturing process is well-established, with multiple suppliers producing the active pharmaceutical ingredients (APIs). Cost reductions are constrained, and margins are low for generic producers.

Financial outlook:

Revenue from Cosopt has decreased sharply since patent expiry, with current sales declining approximately 10-15% annually, mostly attributable to existing stockpiles and legacy contracts.

How should investors approach Cosopt?

In its current state, Cosopt functions as a mature product with limited growth prospects. Investment in the asset is primarily speculative, relying on potential niche applications, reformulation efforts, or legal protections that are unlikely to significantly alter its market position.

Companies with active pipeline drugs for glaucoma or ocular hypertension present better growth opportunities. Existing Cosopt assets offer limited near-term upside unless new formulation patents or indications emerge.

Key takeaways

• Cosopt's patent expiry in 2012-13 led to an erosion of market share by generics.
• The global glaucoma market grew at a CAGR of 4.5%, but Cosopt's contribution has diminished.
• Revenue decline has exceeded 70% since patent expiration.
• Future growth opportunities are limited unless new formulations or indications are developed.
• The market is highly competitive, with pricing pressures favoring generics.

FAQs

Q1: Is there any regulatory filing for new formulations of Cosopt?
No recent filings or approvals for reformulated versions are publicly available.

Q2: Are there any legal protections remaining for Cosopt?
Secondary patents have expired or are weak; legal protections mainly relate to manufacturing patents, which do not prevent generic competition.

Q3: How does Cosopt compare with other combination glaucoma drugs?
It competes with other fixed-dose combinations like Combigan (brimonidine and timolol) and Travatan Z (travoprost). Market share shifts favor newer or more convenient formulations.

Q4: What is the current market sales volume?
Exact sales figures are proprietary, but estimates point to a significant decline from a peak of over USD 200 million annually in the early 2010s to below USD 50 million currently.

Q5: Should investors consider acquiring Cosopt assets?
Limited prospects for revenue growth and high competition suggest caution. Assets might hold value only in niche applications or for companies with specialized R&D programs.

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Citations:
[1] IQVIA. "Global Ophthalmic Market Data," 2022.
[2] U.S. FDA. "Cosopt (dorzolamide hydrochloride and timolol maleate) Approval History," 1998.
[3] MarketResearch.com. "Global Glaucoma Therapeutics Market," 2022.