evekeo odt Drug Patent Profile

Which patents cover Evekeo Odt, and what generic alternatives are available?

Evekeo Odt is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in EVEKEO ODT is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evekeo Odt

A generic version of evekeo odt was approved as amphetamine sulfate by AMNEAL PHARMS on September 26^th, 2018.

Summary for evekeo odt

US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	1,038
Drug Prices:	Drug price information for evekeo odt
What excipients (inactive ingredients) are in evekeo odt?	evekeo odt excipients list
DailyMed Link:	evekeo odt at DailyMed

See drug prices for evekeo odt

US Patents and Regulatory Information for evekeo odt

evekeo odt 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
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021		DISCN	Yes	No			Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019		DISCN	Yes	No			Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No			Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		DISCN	Yes	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019		DISCN	Yes	No			Y

Expired US Patents for evekeo odt

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019

Evekeo odt Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EVEKEO ODT

Introduction

EVEKEO ODT, an orally disintegrating tablet formulation of amphetamine sulfate, is a central nervous system stimulant approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 to 17 years, and more recently, for those aged 3 to 5 years.

Regulatory History and Approval

EVEKEO ODT was initially approved by the FDA on January 30, 2019, for the treatment of ADHD in pediatric patients aged 6 to 17 years. In April 2021, the FDA approved a supplemental new drug application (sNDA) that introduced a 2.5 mg strength for the treatment of ADHD in pediatric patients aged 3 to 5 years[1][4][5].

Market Positioning

EVEKEO ODT is part of a broader market for ADHD medications, which includes other stimulants like Adderall and non-stimulant options. Its unique formulation as an orally disintegrating tablet provides an advantage in terms of ease of administration, particularly for pediatric patients who may have difficulty swallowing traditional tablets[4].

Competitive Landscape

The ADHD medication market is highly competitive, with several established brands and generic options available. EVEKEO ODT competes directly with other amphetamine-based products, such as Adderall, and other stimulant medications. The market is also seeing growth in non-stimulant ADHD treatments, which can influence the overall market dynamics[4].

Patient Population and Indications

EVEKEO ODT is indicated for the treatment of ADHD in pediatric patients aged 3 to 17 years. The expansion to include patients aged 3 to 5 years has broadened its potential patient base. Additionally, it is used for the treatment of narcolepsy and, in some cases, for short-term obesity treatment in patients 12 years of age or older[4].

Dosage and Administration

The medication is available in various strengths, including 2.5 mg, 5 mg, 10 mg, 15 mg, and 20 mg tablets. The dosage is tailored based on the patient's age and response to treatment, with careful monitoring required to adjust the dose as necessary[4][5].

Safety and Adverse Reactions

EVEKEO ODT, like other CNS stimulants, carries several safety concerns, including the risk of sudden death in patients with structural cardiac abnormalities, long-term suppression of growth, psychiatric adverse reactions, and peripheral vasculopathy. These risks necessitate careful patient monitoring and selection[1][5].

Clinical Efficacy

Studies have shown that EVEKEO ODT is effective in controlling symptoms of ADHD, such as inattention, impulsivity, and hyperactivity. A small study published in the Journal of Child and Adolescent Psychopharmacology demonstrated its efficacy in children aged 6 to 12 years compared to a placebo[4].

Financial Performance

The financial trajectory of EVEKEO ODT is influenced by several factors, including prescription rates, competition, and pricing strategies. As a relatively new entrant in the ADHD market, EVEKEO ODT has been gaining traction, particularly with its expanded indication for younger pediatric patients.

• Prescription Trends: EVEKEO ODT has been included in various drug utilization reports, indicating its growing presence in the market. For instance, it is mentioned alongside other top prescription drugs in terms of claim counts and costs[2].
• Revenue Growth: While specific revenue figures for EVEKEO ODT are not publicly disclosed in the sources, the expansion of its indication and its unique formulation suggest potential for revenue growth.
• Pricing and Reimbursement: The pricing of EVEKEO ODT is competitive with other ADHD medications. Reimbursement policies by health insurance providers also play a crucial role in its financial performance.

Generic Availability

As of the latest updates, the original strengths of EVEKEO ODT (5 mg, 10 mg, 15 mg, and 20 mg) have been discontinued, and only the 2.5 mg strength, approved in 2021, remains available. This could impact the financial trajectory as generic versions may enter the market once patents expire[3].

Market Challenges

Despite its unique advantages, EVEKEO ODT faces several market challenges:

• Competition: The ADHD medication market is highly competitive, with well-established brands and a growing number of generic options.
• Safety Concerns: The need for careful monitoring and the potential for serious adverse reactions can affect prescribing rates.
• Regulatory Environment: Changes in regulatory policies or new safety data could impact its market position.

Future Outlook

The future outlook for EVEKEO ODT is promising, given its expanded indication and the growing demand for ADHD treatments. However, it will need to navigate the competitive landscape and address ongoing safety concerns to maintain and grow its market share.

Key Takeaways

• EVEKEO ODT is approved for ADHD treatment in pediatric patients aged 3 to 17 years.
• It offers a unique orally disintegrating tablet formulation.
• The medication has shown efficacy in clinical studies.
• Safety concerns include cardiac risks, growth suppression, and psychiatric adverse reactions.
• The financial trajectory is influenced by prescription trends, competition, and pricing strategies.
• Generic availability could impact future revenue.

Frequently Asked Questions (FAQs)

Q: What is EVEKEO ODT used for? A: EVEKEO ODT is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 3 to 17 years.

Q: How is EVEKEO ODT administered? A: EVEKEO ODT is an orally disintegrating tablet available in various strengths, including 2.5 mg, 5 mg, 10 mg, 15 mg, and 20 mg.

Q: What are the common adverse reactions associated with EVEKEO ODT? A: Common adverse reactions include decreased appetite, insomnia, and potential long-term suppression of growth.

Q: Can EVEKEO ODT be used in patients with heart problems? A: No, EVEKEO ODT should be avoided in patients with known structural cardiac abnormalities or serious heart problems due to the risk of sudden death and other cardiovascular events.

Q: Is EVEKEO ODT available in generic form? A: As of the latest updates, the original strengths of EVEKEO ODT have been discontinued, and only the 2.5 mg strength remains available. Generic versions may enter the market once patents expire.

Cited Sources:

1. FDA: Evekeo Pediatric Postmarketing Safety Review.
2. Colorado Department of Health Care Policy and Financing: DUR Board Minutes February 2024.
3. Drugs.com: Generic Evekeo ODT Availability.
4. ADDitude: Evekeo vs. Evekeo ODT: ADHD Medication Information.
5. FDA: EVEKEO ODT (amphetamine sulfate) Label.