ADZENYS ER Drug Patent Profile

Which patents cover Adzenys Er, and what generic alternatives are available?

Adzenys Er is a drug marketed by Neos Theraps Inc and is included in one NDA. There are three patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in ADZENYS ER 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 Er

There has been one patent litigation case 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 ER

International Patents:	2
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Patent Applications:	6,954
Drug Prices:	Drug price information for ADZENYS ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADZENYS ER
What excipients (inactive ingredients) are in ADZENYS ER?	ADZENYS ER excipients list
DailyMed Link:	ADZENYS ER at DailyMed

See drug prices for ADZENYS ER

Recent Clinical Trials for ADZENYS ER

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 ER clinical trials

US Patents and Regulatory Information for ADZENYS ER

ADZENYS ER 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
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No	8,709,491		Y
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No	9,017,731		Y
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No	9,265,737		Y

International Patents for ADZENYS ER

When does loss-of-exclusivity occur for ADZENYS ER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ADZENYS ER around the world.

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2013003622

ADZENYS ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adzenys ER

Introduction to Adzenys ER

Adzenys ER, an extended-release oral suspension of amphetamine, is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Developed by Neos Therapeutics, this drug utilizes proprietary modified-release drug delivery technology, making it a significant player in the ADHD treatment market.

Market Context: ADHD Drugs Market

The ADHD drugs market is experiencing robust growth, driven by increasing diagnosis rates and the need for effective treatments. According to Technavio, the ADHD drugs market is expected to grow by USD 9.61 billion from 2021 to 2025, accelerating at a CAGR of 9.06% during this period[1].

Competitive Landscape

The ADHD drugs market is fragmented, with several key players including Aurobindo Pharma Ltd., Aytu BioPharma Inc., Eli Lilly and Co., and others. Neos Therapeutics, now part of Aytu BioPharma, holds a unique position with its extended-release products, including Adzenys ER and Adzenys XR-ODT[1].

Product Approval and Launch

Adzenys ER was approved by the FDA in January 2016, following the approval of Adzenys XR-ODT in 2016. This approval marked Neos Therapeutics as the only company offering both branded amphetamine and methylphenidate products in extended-release dosage forms[4].

Growth and Prescription Volume

Since its launch, Adzenys XR-ODT, a closely related product, has shown significant growth. For instance, monthly prescriptions for Cotempla XR-ODT, another Neos product, grew by 29.6% per month since its launch in September 2017. This growth trend is indicative of the potential for Adzenys ER, given its similar technology and market positioning[3].

Financial Performance

The financial performance of Adzenys ER is closely tied to the overall performance of Aytu BioPharma's ADHD portfolio. In fiscal 2024, Aytu BioPharma reported a 23% increase in net revenue for its ADHD portfolio, which includes Adzenys XR-ODT and Cotempla XR-ODT, to $57.8 million compared to $46.9 million in fiscal 2023[2].

Revenue and Market Share

The acquisition of Neos Therapeutics by Aytu BioPharma in 2021 significantly boosted the company's ADHD product revenue. In fiscal 2022, ADHD brands Adzenys XR-ODT and Cotempla XR-ODT experienced a 294% growth in net product revenue to $42.8 million, reflecting the acquisition and integration of the ADHD franchise[5].

Regional Market Analysis

The ADHD drugs market is predominantly driven by North America, which accounts for approximately 40% of the market share. Other key regions include Europe, Asia, and the Rest of the World (ROW)[1].

Consumer and Prescriber Engagement

Neos Therapeutics, and now Aytu BioPharma, have seen a significant increase in the number of prescribers for their ADHD products. As of September 30, 2018, 15,036 healthcare providers had written prescriptions for Adzenys XR-ODT, and 7,485 for Cotempla XR-ODT, indicating strong prescriber acceptance and patient demand[3].

Technological Advantage

Adzenys ER utilizes Neos Therapeutics' proprietary modified-release drug delivery technology, which allows for once-daily dosing and does not require refrigeration or reconstitution at the pharmacy level. This technology provides healthcare providers with the flexibility to transition patients between liquid and ODT formulations, enhancing patient compliance and treatment outcomes[4].

Future Outlook and Growth Prospects

Given the strong growth trajectory of Aytu BioPharma's ADHD portfolio, Adzenys ER is poised for continued success. The company expects net revenue growth across the Rx Segment in fiscal 2025, driven by the performance of its ADHD products. The discontinuation of the Consumer Health Segment is also expected to improve operating cash flows and drive long-term stockholder value[2].

Challenges and Opportunities

While the ADHD drugs market presents significant opportunities, it also faces challenges such as competition from generic and branded products, regulatory hurdles, and seasonal fluctuations due to high deductible plans. However, the unique dosage form and technological advantages of Adzenys ER position it well to navigate these challenges and capitalize on market opportunities[3].

Key Takeaways

• Market Growth: The ADHD drugs market is expected to grow significantly, driven by increasing diagnosis rates and the need for effective treatments.
• Product Performance: Adzenys ER and related products have shown strong growth in prescription volume and revenue.
• Technological Advantage: Proprietary modified-release drug delivery technology enhances patient compliance and treatment outcomes.
• Financial Trajectory: Aytu BioPharma's ADHD portfolio, including Adzenys ER, is expected to continue growing in the coming years.
• Regional Dominance: North America is a key market, but other regions also present significant opportunities.

FAQs

Q: What is Adzenys ER used for? A: Adzenys ER is an extended-release oral suspension of amphetamine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Q: Who developed Adzenys ER? A: Adzenys ER was developed by Neos Therapeutics, which is now part of Aytu BioPharma.

Q: What is the unique feature of Adzenys ER? A: Adzenys ER uses proprietary modified-release drug delivery technology, allowing for once-daily dosing without the need for refrigeration or reconstitution.

Q: How has the ADHD portfolio of Aytu BioPharma performed financially? A: The ADHD portfolio, including Adzenys XR-ODT and Cotempla XR-ODT, saw a 23% increase in net revenue in fiscal 2024 and a 294% growth in fiscal 2022 following the acquisition of Neos Therapeutics.

Q: What are the growth prospects for Adzenys ER? A: Given the strong performance of Aytu BioPharma's ADHD portfolio and the expected growth in the Rx Segment, Adzenys ER is poised for continued success and growth in the coming years.

Cited Sources

1. Technavio: Attention Deficit Hyperactivity Disorder Drugs Market to Record 6.44 ...
2. Biospace: Aytu BioPharma Reports Fiscal 2024 Full Year and Fourth Quarter Operational and Financial Results
3. Globenewswire: Neos Therapeutics Reports Third Quarter 2018 Financial Results
4. Biospace: Neos Therapeutics Receives U.S. FDA Approval Of Adzenys ER ...
5. Biospace: Aytu BioPharma Reports Record Fourth Quarter and Fiscal Year 2022 Revenue