GIMOTI Drug Patent Profile

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

Gimoti is a drug marketed by Evoke Pharma Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in seven countries.

The generic ingredient in GIMOTI is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gimoti

A generic version of GIMOTI was approved as metoclopramide hydrochloride by TEVA on July 29^th, 1985.

Summary for GIMOTI

International Patents:	10
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	1,437
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIMOTI
What excipients (inactive ingredients) are in GIMOTI?	GIMOTI excipients list
DailyMed Link:	GIMOTI at DailyMed

Pharmacology for GIMOTI

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Paragraph IV (Patent) Challenges for GIMOTI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIMOTI	Metered Nasal Spray	metoclopramide hydrochloride	15 mg/spray	209388	1	2021-12-30

US Patents and Regulatory Information for GIMOTI

GIMOTI is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020		RX	Yes	Yes	11,020,361
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020		RX	Yes	Yes	11,813,231		Y
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020		RX	Yes	Yes	8,334,281		Y
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020		RX	Yes	Yes	11,628,150		Y

Expired US Patents for GIMOTI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evoke Pharma Inc	GIMOTI	metoclopramide hydrochloride	SPRAY, METERED;NASAL	209388-001	Jun 19, 2020	6,770,262

International Patents for GIMOTI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010075444
Portugal	2376075
Poland	2376075
Spain	2346290
Austria	466569
Portugal	1274414

GIMOTI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GIMOTI

Introduction

GIMOTI, a nasal spray formulation of metoclopramide developed by Evoke Pharma, Inc., has been making significant strides in the market for the treatment of acute and chronic gastrointestinal (GI) disorders, particularly gastroparesis. Here, we will delve into the market dynamics and financial trajectory of GIMOTI, highlighting key performance indicators, challenges, and future projections.

Market Need and Target Audience

GIMOTI addresses a critical need in the treatment of gastroparesis, a condition characterized by delayed gastric emptying. Traditional oral metoclopramide has limitations, such as variable absorption and side effects, making GIMOTI a promising alternative. The target audience includes patients suffering from gastroparesis, particularly those who have not responded well to oral treatments or prefer a more convenient and effective delivery method[3].

Regulatory Approval and Commercialization

After a series of clinical trials and regulatory submissions, GIMOTI received FDA approval in 2020. This milestone marked the beginning of its commercial journey. Evoke Pharma has since focused on expanding its market share through strategic partnerships and robust marketing efforts[3].

Financial Performance: Recent Quarters

Third Quarter 2024

In the third quarter of 2024, GIMOTI achieved its highest quarterly revenue to date, with net product sales of $2.7 million. This represents a 70% increase year-over-year, driven by strong cumulative prescriber growth and a 52% year-over-year increase in prescription fills. The company also reported a 39% increase in prescription fills since the first quarter of 2024[1].

First Quarter 2024

Despite facing transient challenges such as a cyberattack on the largest U.S. medical claims processor and increased co-pay expenses, the first quarter of 2024 saw net product sales of approximately $1.7 million. This was a 114% year-over-year increase, with a 70% growth in prescriber numbers and a 10% increase in medication fills compared to the fourth quarter of 2023[2][5].

Year-over-Year Growth

The fiscal year 2023 saw a significant 107% increase in net product sales from prescriptions, totaling approximately $5.2 million compared to 2022. This robust growth is a testament to the company's operational excellence and the increasing adoption of GIMOTI by healthcare providers and patients[4].

Operational Expenses and Cash Position

Evoke Pharma has been managing its operational expenses carefully. For the first quarter of 2024, selling, general, and administrative expenses were approximately $3.1 million, slightly higher than the previous year due to increased professional fees and reimbursement activities. As of March 31, 2024, the company had approximately $9.7 million in cash and cash equivalents, which is expected to be sufficient to fund operations into the first quarter of 2025[2][5].

Real-World Data and Clinical Outcomes

Real-world data presented at the ACG 2024 conference demonstrated that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, reducing hospitalizations and ER visits compared to oral metoclopramide. This data reinforces GIMOTI's position as a promising supportive care option[1].

Strategic Partnerships

Evoke Pharma has strengthened its partnership with ASPN Pharmacies, which is expected to enhance service delivery and patient reach. This partnership, along with other marketing efforts, has been instrumental in driving the growth of GIMOTI prescriptions and fills[2][4].

Challenges and Adaptive Strategies

The company faced challenges in the first quarter of 2024, including a cyberattack and increased co-pay expenses. However, Evoke Pharma's adaptive strategies and resilience have helped mitigate these issues, and the company remains confident in its ability to resolve these challenges as the year progresses[2].

Future Projections

For 2024, Evoke Pharma projects net revenue of $14 million, reflecting continued growth and market penetration. The company's focus on operational excellence, strategic partnerships, and robust marketing efforts is expected to drive this growth[4].

Key Takeaways

• Revenue Growth: GIMOTI has seen significant year-over-year revenue growth, with the third quarter of 2024 being the highest to date.
• Prescriber and Prescription Growth: Strong increases in prescriber numbers and prescription fills indicate growing acceptance and adoption of GIMOTI.
• Operational Expenses: Careful management of operational expenses is crucial for sustaining growth.
• Cash Position: The company has a sufficient cash position to fund operations into the first quarter of 2025.
• Clinical Outcomes: Real-world data supports the efficacy of GIMOTI in improving patient outcomes.

FAQs

What is GIMOTI and how does it differ from traditional metoclopramide?

GIMOTI is a nasal spray formulation of metoclopramide, designed to treat gastroparesis. It differs from traditional oral metoclopramide by offering a more convenient and effective delivery method with potentially fewer side effects.

What were the key financial highlights for GIMOTI in the third quarter of 2024?

In the third quarter of 2024, GIMOTI achieved net product sales of $2.7 million, a 70% increase year-over-year, with significant gains in prescriber and prescription fill rates.

How has Evoke Pharma managed operational expenses?

Evoke Pharma has managed its operational expenses by balancing increased professional fees and reimbursement activities with careful financial planning, ensuring sufficient cash reserves to fund operations.

What impact did real-world data have on GIMOTI's market position?

Real-world data presented at ACG 2024 demonstrated that GIMOTI significantly enhanced patient outcomes, reducing hospitalizations and ER visits compared to oral metoclopramide, reinforcing its market position as a promising supportive care option.

What are Evoke Pharma's future revenue projections for GIMOTI?

For 2024, Evoke Pharma projects net revenue of $14 million, driven by continued growth and market penetration of GIMOTI.

Sources

1. Evoke Pharma, Inc. Reports Third Quarter 2024 Financial Results - Investor Relations, Evoke Pharma.
2. Evoke Pharma Reports First Quarter 2024 Financial Results - BioSpace.
3. Evoke Pharma, Inc. - Annual Reports - AnnualReports.com.
4. Evoke Pharma Reports Fourth Quarter and Full Year 2023 Financial Results - Investor Relations, Evoke Pharma.
5. Evoke Pharma Reports First Quarter 2024 Financial Results - GlobeNewswire.