OVIDE Drug Patent Profile

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

Ovide is a drug marketed by Taro and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in six countries.

The generic ingredient in OVIDE is malathion. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the malathion profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ovide

A generic version of OVIDE was approved as malathion by SUVEN PHARMS on May 23^rd, 2012.

Summary for OVIDE

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	76
Patent Applications:	3,167
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OVIDE
DailyMed Link:	OVIDE at DailyMed

Paragraph IV (Patent) Challenges for OVIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OVIDE	Topical Lotion	malathion	0.50%	018613	1	2011-03-16

US Patents and Regulatory Information for OVIDE

OVIDE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No	7,560,445		Y	Y
Taro	OVIDE	malathion	LOTION;TOPICAL	018613-001	Aug 2, 1982		DISCN	Yes	No	7,977,324		Y

International Patents for OVIDE

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

Country	Patent Number	Title	Estimated Expiration
China	103087095	Process for preparing malathion for pharmaceutical use, and combination thereof
Brazil	PI0612686	processo para preparar malation para uso farmacêutico
Japan	2013032405	PROCESS FOR PREPARING MALATHION FOR PHARMACEUTICAL USE
China	101287374	Process for preparing malathion for pharmaceutical use

OVIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ovid Therapeutics

Introduction

Ovid Therapeutics, a biopharmaceutical company focused on rare epilepsies and brain conditions, is navigating a complex and dynamic market. Here, we will delve into the market dynamics and financial trajectory of Ovid Therapeutics, highlighting key developments, challenges, and future prospects.

Market Context

The pharmaceutical industry, particularly the segment focusing on rare and neurological disorders, is experiencing significant growth and transformation. New drug modalities, such as monoclonal antibodies, antibody-drug conjugates (ADCs), and mRNA drugs, are driving this growth, with a projected pipeline value of $168 billion in 2024[3].

Ovid Therapeutics' Focus Areas

Ovid Therapeutics is primarily involved in the development of treatments for rare epilepsies and other brain conditions. Key areas include:

Epilepsy Market

The epilepsy market is anticipated to observe substantial growth, driven by improvements in diagnosis methodologies, rising awareness, and incremental healthcare spending. The market size for epilepsy reached $8.5 billion in 2022 and is expected to grow significantly by 2032[4].

Key Products and Pipeline

Soticlestat

Soticlestat, co-developed with Takeda, is a significant product in Ovid's pipeline. Although Takeda's Phase 3 results did not show clinical benefit for patients with Lennox-Gastaut Syndrome (LGS), Ovid retains a financial interest in the drug. If approved and commercialized, Ovid is eligible for regulatory and commercial milestone payments, as well as tiered royalties up to 20% on global net sales from Takeda[5].

OV888 (GV101) and OV329

Ovid is advancing its clinical pipeline with the addition of the OV888/GV101 Phase 1 Multiple Ascending Dose (MAD) program and expanded OV329 clinical development activities. These programs are crucial for the company's future growth and are supported by increased research and development expenses[5].

Financial Performance

Revenue and Expenses

In the first quarter of 2024, Ovid reported revenue of $148,000, primarily from royalty and licensing agreements, which is an increase from $66,000 in the same period in 2023. Research and development expenses rose to $10.4 million, reflecting the advancement of Ovid's clinical pipeline[2].

For the second quarter of 2024, revenue from royalty agreements was $169,000, up from $75,000 in the same period in 2023. Research and development expenses increased to $12.6 million, partly due to organizational restructuring and the expansion of clinical development activities[5].

Cash Position and Financial Runway

As of June 30, 2024, Ovid's cash, cash equivalents, and marketable securities totaled $77.0 million. The company anticipates its cash runway will support operations and clinical development programs into the first half of 2026[2][5].

Market Dynamics and Growth Drivers

Impact of COVID-19

While not directly related to Ovid's primary focus, the COVID-19 pandemic has highlighted the importance of robust healthcare systems and the need for innovative treatments. This has generally boosted investment in pharmaceutical research and development[1].

New Drug Modalities

The growth in new drug modalities, such as ADCs and mRNA drugs, is driving innovation in the pharmaceutical industry. Ovid's focus on rare epilepsies positions it to benefit from these advancements[3].

Regulatory and Commercial Milestones

The potential approval and commercialization of soticlestat, despite recent setbacks, remain significant drivers for Ovid's financial trajectory. The company's eligibility for milestone payments and royalties from Takeda is a critical factor in its future revenue projections[5].

Challenges and Risks

Clinical Trial Outcomes

The failure of soticlestat to show clinical benefit in Phase 3 trials for LGS patients is a significant setback. However, Ovid is focusing on other pipeline programs to mitigate this risk[5].

Organizational Restructuring

Ovid has undergone organizational restructuring to preserve capital and focus resources on high-priority programs. This includes one-time costs associated with restructuring, which have impacted the company's financial results[5].

Future Prospects

Pipeline Advancement

The advancement of OV888/GV101 and OV329 through clinical trials is crucial for Ovid's future growth. Successful outcomes in these programs could significantly enhance the company's market position and financial performance[5].

Strategic Appointments and Advisory Board

The appointment of Dr. Amanda Banks as Chief Development Officer and the expansion of the Scientific Advisory Board are strategic moves to enhance Ovid's therapeutic opportunities and prioritize efforts where they can most benefit patients[5].

Key Takeaways

• Diverse Pipeline: Ovid Therapeutics has a diverse pipeline with significant potential, including soticlestat, OV888/GV101, and OV329.
• Financial Position: The company has a cash runway that supports operations into the first half of 2026, with revenue primarily from royalty and licensing agreements.
• Market Growth: The epilepsy market is expected to grow significantly, driven by improvements in diagnosis and treatment.
• Regulatory Milestones: Ovid is eligible for milestone payments and royalties from Takeda if soticlestat is approved and commercialized.
• Challenges: Clinical trial outcomes and organizational restructuring are key challenges that Ovid is addressing.

FAQs

1. What is the current focus of Ovid Therapeutics? Ovid Therapeutics is primarily focused on developing treatments for rare epilepsies and other brain conditions.

2. What is the status of soticlestat? Soticlestat did not show clinical benefit in Phase 3 trials for Lennox-Gastaut Syndrome (LGS) patients, but Ovid retains a financial interest in the drug and is eligible for milestone payments and royalties if it is approved and commercialized.

3. How is Ovid Therapeutics advancing its clinical pipeline? Ovid is advancing its clinical pipeline with the addition of the OV888/GV101 Phase 1 MAD program and expanded OV329 clinical development activities.

4. What is Ovid Therapeutics' current cash position? As of June 30, 2024, Ovid's cash, cash equivalents, and marketable securities totaled $77.0 million.

5. What are the key drivers for Ovid Therapeutics' future growth? The key drivers include the advancement of its pipeline programs, potential approval and commercialization of soticlestat, and the growth in the epilepsy market.

Sources

1. Mordor Intelligence - Lice Treatment Market - Analysis, Size & Trends
2. Biospace - Ovid Therapeutics Reports Business Updates and First Quarter 2024 Financial Results
3. BCG - The 2024 New Drug Modalities Report
4. GlobeNewswire - Epilepsy Market to Observe Stunning Growth by 2032, Predicts DelveInsight
5. GlobeNewswire - Ovid Therapeutics Reports Business Updates and Second Quarter 2024 Financial Results