ADZENYS XR-ODT Drug Patent Profile

When do Adzenys Xr-odt patents expire, and when can generic versions of Adzenys Xr-odt launch?

Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in ADZENYS XR-ODT is amphetamine. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Adzenys Xr-odt

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ADZENYS XR-ODT

International Patents:	2
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Patent Applications:	4,367
Drug Prices:	Drug price information for ADZENYS XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADZENYS XR-ODT
What excipients (inactive ingredients) are in ADZENYS XR-ODT?	ADZENYS XR-ODT excipients list
DailyMed Link:	ADZENYS XR-ODT at DailyMed

See drug prices for ADZENYS XR-ODT

Recent Clinical Trials for ADZENYS XR-ODT

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
Duke University	Phase 2

See all ADZENYS XR-ODT clinical trials

Pharmacology for ADZENYS XR-ODT

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for ADZENYS XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADZENYS XR-ODT	Extended-release Orally Disintegrating Tablets	amphetamine	3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg	204326	1	2016-05-10

US Patents and Regulatory Information for ADZENYS XR-ODT

ADZENYS XR-ODT is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016		RX	Yes	Yes	9,017,731		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016		RX	Yes	Yes	9,265,737		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016		RX	Yes	No	8,709,491		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016		RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-005	Jan 27, 2016		RX	Yes	No	9,839,619		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016		RX	Yes	No	8,840,924		Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016		RX	Yes	No	9,017,731		Y

International Patents for ADZENYS XR-ODT

See the table below for patents covering ADZENYS XR-ODT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003622
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)

ADZENYS XR-ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ADZENYS XR-ODT

Introduction

ADZENYS XR-ODT, a long-acting amphetamine formulation, is a significant player in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Developed with sophisticated microparticle delivery technology, this medication offers a unique approach to managing ADHD symptoms throughout the day. Here, we delve into the market dynamics and financial trajectory of ADZENYS XR-ODT.

Market Position and Competition

ADZENYS XR-ODT is part of a competitive ADHD treatment market, which includes various stimulant and non-stimulant medications. The drug's unique delivery system, combining immediate and extended-release microparticles, sets it apart from other treatments. This technology ensures a consistent release of the medication throughout the day, enhancing patient compliance and efficacy[1].

Prescription Trends and Market Growth

The prescription volume for ADZENYS XR-ODT has shown significant growth over the years. For instance, in the third quarter of 2018, Neos Therapeutics reported a 9% increase in prescription volume for their ADHD products, including ADZENYS XR-ODT, compared to the previous quarter[3].

In recent years, Aytu BioPharma, the current manufacturer, has reported continued growth in the ADHD portfolio, which includes ADZENYS XR-ODT and Cotempla XR-ODT. In fiscal 2024, the ADHD portfolio net revenue increased by 23% to $57.8 million compared to $46.9 million in fiscal 2023[2].

Financial Performance

Revenue Growth

The financial performance of ADZENYS XR-ODT is closely tied to the overall performance of Aytu BioPharma's Rx Segment. In fiscal 2024, the Rx Segment net revenue was $65.2 million, with the ADHD portfolio contributing substantially to this figure. The net revenue from the ADHD portfolio increased by 23% year-over-year, reflecting strong market demand and effective commercial strategies[2].

Quarterly Performance

In the first quarter of fiscal 2024, the ADHD products, including ADZENYS XR-ODT, saw a 31% increase in net revenue compared to the same period in the previous year. This growth was despite a slight decline in the overall Rx Segment revenue due to other factors such as changes in payor coverage and the wind-down of the Consumer Health Segment[5].

Gross Margin and Operating Expenses

The gross margin for the Rx Segment, which includes ADZENYS XR-ODT, improved to 76% in the fourth quarter of fiscal 2024, up from 75% in the same quarter of the previous year. This improvement is a result of enhanced operational efficiencies and reduced spending in the Consumer Health Segment[2].

Operating expenses have been managed effectively, with a decrease in the fourth quarter of fiscal 2024 compared to the prior year period. This reduction is largely due to the discontinuation of the Consumer Health Segment and improved operational efficiencies[2].

Impact of Market Factors

COVID-19 Pandemic

The COVID-19 pandemic had a significant impact on the prescription trends of stimulant medications, including ADZENYS XR-ODT. There was a temporary decline in stimulant prescriptions immediately after the pandemic restrictions were implemented, but by October 2020, prescription levels had rebounded to pre-pandemic levels. The use of telemedicine also increased during this period, with a notable rise in new therapy starts (NTS) prescribed through telemedicine visits[4].

Seasonality and Supply Chain

Seasonal factors, such as high deductible plans, can affect the net revenue per pack of ADZENYS XR-ODT. For example, in the third quarter of 2018, the net revenue per pack was $108, which was higher than the previous quarter due to seasonal factors[3].

Supply chain normalization in the ADHD market also impacted the revenue in the fourth quarter of fiscal 2024, leading to a 13% decrease in net revenue for the ADHD portfolio compared to the prior year period. However, the second half of fiscal 2024 saw an 8% increase in net revenue for the ADHD portfolio compared to the same period in fiscal 2023[2].

Future Outlook

Aytu BioPharma expects continued growth in the Rx Segment, including the ADHD portfolio, in fiscal 2025. The company has expressed confidence in its ability to drive revenue growth and improve profitability, supported by its solid financial position and operational efficiencies[2].

Key Takeaways

• Market Growth: ADZENYS XR-ODT has seen significant growth in prescription volume and revenue.
• Financial Performance: The drug contributes substantially to Aytu BioPharma's Rx Segment revenue, with a 23% year-over-year increase in fiscal 2024.
• Operational Efficiencies: Improved gross margins and reduced operating expenses have enhanced the financial trajectory.
• Market Factors: The COVID-19 pandemic and supply chain normalization have had temporary impacts, but the overall trend remains positive.
• Future Outlook: Aytu BioPharma anticipates continued growth in the ADHD portfolio in fiscal 2025.

FAQs

What is ADZENYS XR-ODT used for?

ADZENYS XR-ODT is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

How does ADZENYS XR-ODT work?

ADZENYS XR-ODT uses a sophisticated microparticle delivery technology, combining immediate and extended-release microparticles to release the medication throughout the day.

What was the revenue growth for ADZENYS XR-ODT in fiscal 2024?

The ADHD portfolio, which includes ADZENYS XR-ODT, saw a 23% increase in net revenue to $57.8 million in fiscal 2024 compared to fiscal 2023.

How did the COVID-19 pandemic affect ADZENYS XR-ODT prescriptions?

The pandemic led to a temporary decline in stimulant prescriptions but rebounded to pre-pandemic levels by October 2020, with an increase in telemedicine prescriptions.

What is the future outlook for ADZENYS XR-ODT?

Aytu BioPharma expects continued growth in the Rx Segment, including the ADHD portfolio, in fiscal 2025, driven by solid financial performance and operational efficiencies.

Sources

1. ADZENYS XR-ODT - Adzenys XR-ODT Official Website
2. Aytu BioPharma Reports Fiscal 2024 Full Year and Fourth Quarter Operational and Financial Results - BioSpace
3. Neos Therapeutics Reports Third Quarter 2018 Financial Results - GlobeNewswire
4. IQVIA Report on Stimulant Trends from 2012 - 2022 - US Department of Justice
5. Aytu BioPharma Reports Fiscal 2024 First Quarter Financial Results - AccessWire