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. Eighteen 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:	92
Clinical Trials:	35
Patent Applications:	385
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
Mid Atlantic Retina	Phase 2/Phase 3
Wills Eye	Phase 2/Phase 3
Mid Atlantic Retina	Phase 2

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
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
World Intellectual Property Organization (WIPO)	9218124
Cyprus	2146	Opthalmic compositions comprising combinations of a carbonic anhydrase inhibitor and a beta-adrenergic antagonist
Luxembourg	88633
Denmark	0509752

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	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
0296879	96C0003	Belgium		PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219
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

COSOPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COSOPT

Introduction

COSOPT, a combination medication of dorzolamide and timolol, is a pivotal treatment for glaucoma and other conditions involving high intraocular pressure. Understanding the market dynamics and financial trajectory of COSOPT is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global antiglaucoma drugs market, which includes COSOPT, has been experiencing significant growth. The market is projected to grow from $15.07 billion in 2023 to $16.27 billion in 2024, with a compound annual growth rate (CAGR) of 7.9%. By 2028, the market is expected to reach $21.9 billion, driven by factors such as emerging markets, reimbursement policies, and disease awareness campaigns[1].

Product Overview

COSOPT is a combination formulation that includes dorzolamide 2% and timolol 0.5%, dosed twice daily. This combination provides equivalent treatment to using each active ingredient separately, offering convenience without compromising therapeutic efficacy. It is as effective as other treatments like latanoprost in lowering intraocular pressure, although it may be less well-tolerated due to side effects such as ocular burning[4].

Historical Performance

COSOPT gained FDA approval in April 1998 and was initially supplied by Merck. In the years following its approval, COSOPT generated significant revenue; for example, it had annual sales of $342 million during the 12 months before June 2008. In 2013, Merck & Co. sold the U.S. rights to their ophthalmic product line, including COSOPT, to Akorn Inc. for $52.8 million[4].

Generic Competition

The original patent for COSOPT has expired, leading to the entry of generic competitors. Hi-Tech Pharma was the first to submit an abbreviated new drug application (ANDA) for generic COSOPT, which was approved in October 2008. Other companies like Apotex, Sandoz, Bausch & Laumb, and Teva have also received approvals for their generic versions. This competition has likely impacted the market share and pricing of the branded version of COSOPT[4].

Financial Performance of Key Players

Santen Pharmaceutical, a major player in the ophthalmic market, has shown strong financial performance in recent years. In FY2023, Santen achieved its highest revenue and core operating profit, with revenue reaching JPY 302.0 billion (+8.2% YoY) and core operating profit at JPY 62.8 billion (+41.9% YoY). The company has also made significant progress in R&D, including approvals for new products and advancements in areas like myopia and ptosis[2].

Market Segmentation

The antiglaucoma drugs market, including COSOPT, is segmented by type and product type. Hospital prescription drugs and over-the-counter (OTC) drugs are the primary segments by type. By product type, the market includes alpha agonists, beta blockers, prostaglandin analogs, combined medications, and other types. COSOPT falls under the combined medication category, which is a significant segment due to its convenience and efficacy[1].

Regional Performance

The market performance of COSOPT and similar drugs varies by region. Santen Pharmaceutical has seen strong growth in overseas markets, including EMEA (Europe, Middle East, and Africa) and Asia, which have contributed significantly to their revenue. For instance, in FY2023, overseas sales (including China, Asia, and EMEA) increased by 6% YoY, while Japan saw a decline of 6% YoY[2].

Impact of External Factors

The market for COSOPT and other antiglaucoma drugs is influenced by various external factors, including regulatory changes, economic conditions, and global events. For example, the COVID-19 pandemic and the Ukraine-Russia war have had impacts on the market, as have changes in healthcare expenditure and reimbursement policies[1].

Technological Advancements and Innovation

Technological advancements and innovation are key drivers in the antiglaucoma drugs market. Trends such as telemedicine, biologics, novel therapies, and sustained-release formulations are expected to shape the future of the market. Companies like Santen Pharmaceutical are investing heavily in R&D to develop new products and improve existing ones, which will likely influence the market trajectory of COSOPT and similar drugs[1].

Sustainability and Eco-Friendly Packaging

Sustainability and eco-friendly packaging are becoming increasingly important in the pharmaceutical industry. As consumers and regulatory bodies place more emphasis on environmental sustainability, companies are likely to adapt their packaging and production processes to meet these demands. This could impact the cost structure and market appeal of COSOPT and other antiglaucoma drugs[1].

Competitive Landscape

The competitive landscape for COSOPT includes both branded and generic versions. The entry of generic competitors has increased competition, potentially affecting the pricing and market share of the branded product. However, the convenience and efficacy of COSOPT continue to make it a preferred choice for many patients and healthcare providers[4].

Future Outlook

The future outlook for COSOPT and the broader antiglaucoma drugs market is positive, driven by growing demand, technological advancements, and increasing awareness of glaucoma. The market is expected to continue growing, with a CAGR of 7.7% from 2023 to 2028. Companies like Santen Pharmaceutical are well-positioned to capitalize on this growth through their strong R&D pipelines and strategic market presence[1].

Key Takeaways

• The global antiglaucoma drugs market, including COSOPT, is growing strongly.
• COSOPT is a combination formulation of dorzolamide and timolol, offering convenience and efficacy.
• Generic competition has impacted the market share and pricing of COSOPT.
• Regional performance varies, with strong growth in overseas markets.
• Technological advancements and innovation are key drivers in the market.
• Sustainability and eco-friendly packaging are becoming important factors.

FAQs

What is COSOPT used for?

COSOPT is used to treat high pressure inside the eye, including conditions such as glaucoma.

Who are the key players in the market for COSOPT?

Key players include Merck & Co., Akorn Inc., and Santen Pharmaceutical, along with several generic manufacturers.

How has the generic competition affected COSOPT?

Generic competition has led to increased market competition, potentially affecting the pricing and market share of the branded product.

What are the key drivers of the antiglaucoma drugs market?

Key drivers include growing demand, technological advancements, increasing awareness of glaucoma, and emerging markets.

What is the future outlook for the antiglaucoma drugs market?

The market is expected to continue growing, with a CAGR of 7.7% from 2023 to 2028, driven by growing demand and technological advancements.

Sources

1. The Business Research Company, "Global Antiglaucoma Drugs Market Report 2024"
2. Santen Pharmaceutical, "FY2023 Financial Results"
3. National Bureau of Economic Research, "The Economics of Drug Development: Pricing and Innovation in a Changing Market"
4. Wikipedia, "Dorzolamide/timolol"
5. Santen Pharmaceutical, "Q2 FY2022 Financial Results"