OMIDRIA Drug Patent Profile

Which patents cover Omidria, and when can generic versions of Omidria launch?

Omidria is a drug marketed by Rayner Surgical and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in thirty-seven countries.

The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omidria

A generic version of OMIDRIA was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1^st, 2019.

Summary for OMIDRIA

International Patents:	55
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	5
Drug Prices:	Drug price information for OMIDRIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMIDRIA
What excipients (inactive ingredients) are in OMIDRIA?	OMIDRIA excipients list
DailyMed Link:	OMIDRIA at DailyMed

See drug prices for OMIDRIA

Recent Clinical Trials for OMIDRIA

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

Sponsor	Phase
Luigi Rondas	Phase 3
European Society of Cataract and Refractive Surgeons	Phase 3
University of Florida	Phase 4

See all OMIDRIA clinical trials

Pharmacology for OMIDRIA

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for OMIDRIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMIDRIA	Injection	ketorolac tromethamine; phenylephrine hydrochloride	1%/0.3%	205388	1	2015-05-29

US Patents and Regulatory Information for OMIDRIA

OMIDRIA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,855,246		Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,066,856*PED				Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes	9,486,406*PED				Y

Expired US Patents for OMIDRIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,278,101*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,173,707*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	8,586,633*PED
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	9,399,040*PED

International Patents for OMIDRIA

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

Country	Patent Number	Title	Estimated Expiration
China	104822265	Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Cyprus	1124481
European Patent Office	1534313	SOLUTIONS ET PROCEDE D'IRRIGATION OPHTALMOLOGIQUE (OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD)
Portugal	2911511
South Korea	20210018954	주사용의 안정한 보존제-비함유 산동 및 항-염증 용액 (- - STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)

Supplementary Protection Certificates for OMIDRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	1590074-9	Sweden		PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	264 5031-2015	Slovakia		PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	C20150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015

Market Dynamics and Financial Trajectory for OMIDRIA

Introduction

OMIDRIA, a pharmaceutical product developed by Omeros Corporation, is a phenylephrine and ketorolac intraocular solution used in ophthalmic surgery. This article delves into the market dynamics and financial trajectory of OMIDRIA, highlighting key developments, financial performance, and strategic maneuvers that have shaped its market presence.

Market Context and Reimbursement

OMIDRIA operates within a favorable reimbursement environment. The drug qualifies for separate payment under the Hospital Outpatient Prospective Payment System and the Consolidated Appropriations Act of 2023, which enhances its market penetration in ambulatory surgery centers (ASCs) and hospital outpatient departments[3][4].

Sales Performance

In recent years, OMIDRIA has shown steady growth in sales. For the third quarter of 2021, OMIDRIA revenues were $30.0 million, a 4.1% increase over the second quarter, primarily driven by growth in ASCs[1]. In the first quarter of 2022, Omeros earned royalties of $13.8 million based on Rayner’s net sales of $27.7 million in the U.S., indicating a significant increase from the prior year quarter[2].

Royalty Monetization

A pivotal development in OMIDRIA's financial trajectory is the expanded royalty deal with DRI Healthcare Acquisitions LP. This deal resulted in a $115 million upfront payment to Omeros and the potential for an additional $55 million in sales-based milestones. This transaction not only boosts Omeros's immediate liquidity but also extinguishes the $174 million in annual caps payable by Omeros, thereby improving its balance sheet[3][4][5].

Financial Impact

The royalty monetization deal has several financial implications for Omeros:

• Immediate Liquidity: The $115 million upfront payment provides significant immediate capital, which can be used to fund ongoing operations or invest in new product development without diluting shareholder equity[3][5].
• Reduced Liabilities: The elimination of the annual caps reduces Omeros's liabilities, which is viewed positively by investors and credit rating agencies[3].
• Performance-Based Milestones: The deal includes milestone payments contingent on reaching certain sales thresholds, aligning DRI's returns with Omeros's commercial success[3][4].

Reimbursement and Market Penetration

The favorable reimbursement landscape for OMIDRIA has been a key factor in its market success. The drug's eligibility for separate payment under CMS policies enhances its adoption in ASCs and hospital outpatient departments. This environment is crucial for investors as it directly impacts the product's adoption rate and, consequently, the royalty revenue stream[3][4].

Patent Duration and Market Exclusivity

OMIDRIA's patent life, which extends into 2035 in the United States, is a critical factor in maintaining its market exclusivity. The longevity of the patent allows Omeros to maintain higher pricing and market share before facing generic competition[3].

Global Market Strategy

Omeros has retained the ex-U.S. royalties and will revert to global royalties after 2031. This strategy suggests a long-term view, balancing immediate financial needs with the anticipation of future growth in international markets. Analyzing global market trends for ophthalmic products and competitive positioning is essential for projecting the long-term value of Omeros's retained royalty rights[3].

Financial Results and Operating Expenses

In the first quarter of 2024, Omeros reported a net loss of $37.2 million, or $0.63 per share, with net loss from continuing operations being $43.9 million. The company earned OMIDRIA royalties of $9.4 million on Rayner’s U.S. net sales of $31.2 million. Operating expenses increased due to higher research and development costs and patent and legal costs[5].

Interest and Other Income

Interest expense during the first quarter of 2024 was $8.2 million, slightly higher than the prior year quarter due to the amended royalty purchase agreement with DRI. Omeros also earned $3.4 million in interest and other income, slightly lower than the prior year due to the availability of cash and investments[5].

Net Income from Discontinued Operations

Net income from discontinued operations was $6.7 million, or $0.12 per share, in the first quarter of 2024, compared to $6.0 million, or $0.09 per share, in the first quarter of 2023. This reflects the ongoing impact of the sale of OMIDRIA as an asset and the reclassification of related revenues and expenses[5].

DRI Healthcare's Perspective

From DRI Healthcare's standpoint, the expanded deal generates immediate accretive value and provides exposure to an important non-opioid pain drug. The transaction aligns with DRI's strategy of investing in life sciences innovation and is expected to have a significant impact on both near- and long-term cash flow profiles. DRI Healthcare has increased its deployment target and CAGR guidance following this transaction[4].

Key Takeaways

• Favorable Reimbursement Environment: OMIDRIA's eligibility for separate payment enhances its market penetration.
• Royalty Monetization: The deal with DRI Healthcare provides immediate liquidity and reduces liabilities.
• Patent Duration: The patent life extending into 2035 maintains market exclusivity.
• Global Strategy: Omeros retains ex-U.S. royalties and plans for future global market growth.
• Financial Performance: Omeros continues to report net losses but sees growth in OMIDRIA royalties.

FAQs

What is OMIDRIA used for?

OMIDRIA is a phenylephrine and ketorolac intraocular solution used in ophthalmic surgery to reduce pain and inflammation.

How has the royalty deal with DRI Healthcare impacted Omeros?

The deal provided Omeros with a $115 million upfront payment, reduced liabilities by extinguishing annual caps, and introduced performance-based milestone payments.

What is the significance of OMIDRIA's patent duration?

The patent life extending into 2035 allows Omeros to maintain higher pricing and market share before facing generic competition.

How does the reimbursement environment affect OMIDRIA's market performance?

The favorable reimbursement environment under CMS policies enhances OMIDRIA's adoption in ASCs and hospital outpatient departments, directly impacting the royalty revenue stream.

What are the long-term implications of Omeros retaining ex-U.S. royalties?

Retaining ex-U.S. royalties allows Omeros to balance immediate financial needs with the anticipation of future growth in international markets, suggesting a long-term strategic view.

Sources

1. Omeros Corporation Reports Third Quarter 2021 Financial Results. Investor.Omeros.com.
2. Omeros Corporation Reports First Quarter 2022 Financial Results. Investor.Omeros.com.
3. Omeros Corporation Announces Additional Royalty Monetization. Stocktitan.net.
4. DRI Healthcare Trust Announces the Expansion of its Royalty Entitlement on the US Net Sales of Omidria. DRIHealthcare.com.
5. Omeros Corporation Reports First Quarter 2024 Financial Results. Businesswire.com.