QLOSI Drug Patent Profile

When do Qlosi patents expire, and what generic alternatives are available?

Qlosi is a drug marketed by Orasis Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-four patent family members in fourteen countries.

The generic ingredient in QLOSI is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qlosi

A generic version of QLOSI was approved as pilocarpine hydrochloride by PADAGIS US on November 16^th, 2004.

Summary for QLOSI

International Patents:	24
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in QLOSI?	QLOSI excipients list
DailyMed Link:	QLOSI at DailyMed

Pharmacology for QLOSI

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists Cholinergic Muscarinic Agonists

US Patents and Regulatory Information for QLOSI

QLOSI is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	11,129,812
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	9,867,810		Y
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	10,639,297		Y
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes	11,974,986
Orasis Pharms	QLOSI	pilocarpine hydrochloride	SOLUTION;OPHTHALMIC	217836-001	Oct 17, 2023		RX	Yes	Yes

International Patents for QLOSI

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112019002967
South Korea	102588499
Israel	264664
European Patent Office	4190328	COMPOSITIONS PHARMACEUTIQUES OPHTALMIQUES ET UTILISATIONS ASSOCIÉES (OPHTHALMIC PHARMACEUTICAL COMPOSITIONS AND USES RELATING THERETO)
Poland	3500255
Russian Federation	2019107585	ОФТАЛЬМОЛОГИЧЕСКИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И ИХ ПРИМЕНЕНИЕ

QLOSI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Qlosi

Introduction

Qlosi, a novel corrective eye drop developed by Orasis Pharmaceuticals, is poised to revolutionize the treatment of presbyopia in adults. This article delves into the market dynamics and financial trajectory of Qlosi, highlighting key agreements, financing, and the potential impact on the ophthalmic pharmaceutical market.

What is Qlosi?

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% is a groundbreaking eye drop designed for the treatment of presbyopia. It features the lowest effective concentration of pilocarpine approved, combined with a multi-faceted vehicle, and does not contain an anti-microbial preservative. This formulation aims to balance efficacy, safety, and comfort[4].

Licensing Agreement with Optus Pharmaceuticals

A significant milestone in the market dynamics of Qlosi is the exclusive licensing agreement between Orasis Pharmaceuticals and Optus Pharmaceuticals. This agreement grants Optus the rights to commercialize, import, and sell Qlosi in Korea. The terms include an upfront payment, milestone payments totaling $18 million, and double-digit royalties on sales in the Korean market. This partnership is crucial for Orasis' global expansion strategy, aiming to launch Qlosi in Korea by 2026 after receiving the necessary regulatory approvals[1][4].

Financial Trajectory: Recent Financing

Orasis Pharmaceuticals has secured substantial financing to support the commercial launch of Qlosi. A Series D financing round, co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc., raised $78 million. This financing includes a $68 million equity component and $15 million in structured capital from Catalio Capital Management. This funding is pivotal for the successful launch of Qlosi in the U.S. market, enabling Orasis to provide the eye care community with a near-vision solution that balances efficacy and tolerability[5].

Market Impact: Presbyopia Treatment

Presbyopia, a common age-related condition affecting near vision, presents a significant market opportunity. Qlosi's innovative formulation and approval by regulatory bodies position it as a leading treatment option. The licensing agreement with Optus Pharmaceuticals and the planned launch in Korea will expand Qlosi's reach, potentially capturing a substantial share of the global presbyopia treatment market.

Competitive Landscape

The ophthalmic pharmaceutical market is highly competitive, with several players vying for market share. However, Qlosi's unique formulation and the backing of significant financing and strategic partnerships set it apart. The generic drug industry dynamics, as studied by the Federal Trade Commission, indicate that market competition can drive prices down and increase innovation. However, Qlosi's status as a novel, branded product protects it from immediate generic competition, allowing it to maintain a premium position in the market[3].

Regulatory Approvals and Launch Timeline

Qlosi has already received FDA approval in the U.S., a critical step in its commercialization. The planned launch in Korea by 2026, following domestic regulatory approval, further expands its global footprint. Regulatory approvals are a crucial factor in the financial trajectory of pharmaceutical products, and Orasis' progress in this area is a positive indicator of its market potential[1][4].

Revenue Projections and Royalties

The licensing agreement with Optus Pharmaceuticals includes double-digit royalties on sales in the Korean market, in addition to the $18 million in milestone payments. This revenue stream will contribute significantly to Orasis' financial performance. The company's ability to secure such favorable terms reflects the market's confidence in Qlosi's potential[1][4].

Global Expansion Strategy

Orasis Pharmaceuticals' strategy to bring Qlosi to more patients globally is evident through its licensing agreements and financing efforts. By partnering with regional experts like Optus Pharmaceuticals, Orasis can leverage local market knowledge and distribution networks to accelerate Qlosi's adoption. This approach aligns with the company's mission to reshape vision possibilities worldwide[1][4].

Industry Expert Insights

Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals, emphasized the importance of the licensing agreement and the recent financing: "Building on the momentum of our recent Series D financing to support our first market launch in the U.S., this partnership represents our commitment to bring Qlosi to more patients globally and define what's next in vision care."[1][4]

Market Size and Growth Potential

The global presbyopia treatment market is substantial and growing, driven by an aging population and increasing demand for effective treatments. Qlosi's entry into this market, supported by robust financing and strategic partnerships, positions it for significant growth. The success of Qlosi can also drive further innovation in ophthalmic pharmaceuticals, contributing to the overall growth of the sector.

Challenges and Opportunities

While Qlosi faces competition from existing treatments, its innovative formulation and regulatory approvals present a compelling value proposition. The main challenge will be in executing the commercial launch effectively, both in the U.S. and internationally. However, with the backing of significant financing and strategic partnerships, Orasis is well-equipped to overcome these challenges and capitalize on the market opportunities.

Key Takeaways

• Innovative Product: Qlosi is a novel corrective eye drop for presbyopia with a unique formulation.
• Licensing Agreement: Exclusive agreement with Optus Pharmaceuticals for commercialization in Korea.
• Financing: $78 million Series D financing to support U.S. commercial launch.
• Regulatory Approvals: FDA approval in the U.S. and planned launch in Korea by 2026.
• Revenue Projections: Double-digit royalties and milestone payments from the licensing agreement.
• Global Expansion: Strategic partnerships to expand Qlosi's global reach.

FAQs

What is Qlosi used for?

Qlosi is used for the treatment of presbyopia in adults. It is a corrective eye drop containing pilocarpine hydrochloride ophthalmic solution 0.4%.

Who developed Qlosi?

Qlosi was developed by Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company.

What is the significance of the licensing agreement with Optus Pharmaceuticals?

The licensing agreement allows Optus Pharmaceuticals to commercialize, import, and sell Qlosi in Korea, marking a significant step in Orasis' global expansion strategy.

How much financing did Orasis secure for the commercial launch of Qlosi?

Orasis secured $78 million in financing through a Series D financing round to support the U.S. commercial launch of Qlosi.

When is Qlosi expected to be launched in Korea?

Qlosi is expected to be launched in Korea by 2026, following domestic regulatory approval and sales approval.

Sources

1. Orasis Pharmaceuticals Announces Licensing Agreement with Optus Pharmaceuticals for Commercialization of Qlosi in Korea. Biospace.
2. Servier confirms its 2025 trajectory to achieve its 2030 ambition. Servier.
3. Generic Drug Industry Dynamics. Federal Trade Commission.
4. Orasis Pharmaceuticals Announces Licensing Agreement with Optus Pharmaceuticals for Commercialization of Qlosi in Korea. PR Newswire.
5. Orasis secures financing to support US commercial launch of Qlosi. Glance. Eyes on Eyecare.