COTEMPLA XR-ODT Drug Patent Profile

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

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

This drug has eight patent family members in five countries.

The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cotempla Xr-odt

A generic version of COTEMPLA XR-ODT was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

Summary for COTEMPLA XR-ODT

International Patents:	8
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	4,460
Drug Prices:	Drug price information for COTEMPLA XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COTEMPLA XR-ODT
What excipients (inactive ingredients) are in COTEMPLA XR-ODT?	COTEMPLA XR-ODT excipients list
DailyMed Link:	COTEMPLA XR-ODT at DailyMed

See drug prices for COTEMPLA XR-ODT

Pharmacology for COTEMPLA XR-ODT

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

Paragraph IV (Patent) Challenges for COTEMPLA XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COTEMPLA XR-ODT	Extended-release Orally Disintegrating Tablets	methylphenidate	8.6 mg, 17.3 mg and 25.9 mg	205489	1	2017-09-01

US Patents and Regulatory Information for COTEMPLA XR-ODT

COTEMPLA XR-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
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	11,166,947
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017		RX	Yes	No	8,840,924		Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	8,840,924		Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-003	Jun 19, 2017		RX	Yes	Yes	8,840,924		Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017		RX	Yes	No	9,072,680		Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	9,089,496		Y

International Patents for COTEMPLA XR-ODT

When does loss-of-exclusivity occur for COTEMPLA XR-ODT?

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 COTEMPLA XR-ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2020504763	メチルフェニデートを用いてＡＤＨＤを処置するための小児の有効な投薬
Australia	2017353921	Effective dosing of a child for the treatment of ADHD with methylphenidate
South Korea	20240033130	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 (ADHD EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)
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
European Patent Office	3585439	DOSAGE EFFICACE D'UN ENFANT POUR LE TRAITEMENT DU TDAH AVEC DU MÉTHYLPHÉNIDATE (EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)

COTEMPLA XR-ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cotempla XR-ODT

Introduction to Cotempla XR-ODT

Cotempla XR-ODT is an extended-release orally disintegrating tablet formulation of methylphenidate, designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 to 17 years. It is one of the key products in Aytu BioPharma's ADHD portfolio, alongside Adzenys XR-ODT.

Market Need and Competitive Landscape

The ADHD market, particularly in North America, has seen significant growth and demand for innovative treatment options. Cotempla XR-ODT fills a critical need by offering a convenient, once-daily orally disintegrating tablet, which is especially beneficial for patients who have difficulty swallowing traditional tablets[1].

In the Canadian market, Cotempla XR-ODT and Adzenys XR-ODT are poised to be the only orally disintegrating, extended-release tablets for ADHD treatment once approved by Health Canada. This exclusivity is expected to enhance their market position and patient adoption[1].

Prescription Trends and Growth

Since its launch, Cotempla XR-ODT has demonstrated strong prescription growth. Monthly prescriptions for Cotempla XR-ODT have grown significantly, with a 29.6% monthly increase since its launch in September 2017[3].

In the fiscal year 2024, the ADHD portfolio, which includes Cotempla XR-ODT and Adzenys XR-ODT, saw a 23% increase in net revenue to $57.8 million compared to the previous year. This growth underscores the increasing acceptance and demand for these products[5].

Financial Performance

Revenue Growth

The financial performance of Cotempla XR-ODT has been robust. In the first quarter of fiscal 2024, net revenue from Aytu's ADHD products, including Cotempla XR-ODT, increased by 31% to $15.1 million compared to the same period in the previous year[2].

For the full year of fiscal 2024, the ADHD portfolio's net revenue grew by 23% to $57.8 million, highlighting the sustained demand and market acceptance of Cotempla XR-ODT[5].

Gross Margin and Operational Efficiencies

The Rx Segment, which includes Cotempla XR-ODT, saw an improvement in gross margin to 75% in fiscal 2024 compared to 71% in fiscal 2023. This improvement is attributed to better operational efficiencies and reduced costs in other segments[5].

Regulatory and Market Expansion

Aytu BioPharma has entered into an exclusive agreement with Lupin Pharma Canada Ltd to commercialize Cotempla XR-ODT and Adzenys XR-ODT in Canada. This partnership is expected to expand Aytu's reach into one of the world's largest ADHD markets outside the United States. Regulatory approvals in Canada are anticipated within the next 18 to 24 months[1].

Challenges and Risks

Adverse Reactions and Safety Concerns

Cotempla XR-ODT, like other methylphenidate products, carries risks such as abuse, misuse, and addiction. It also has potential adverse reactions including long-term suppression of growth in pediatric patients, increased intraocular pressure, and the worsening of tics or Tourette’s syndrome[4].

Market Normalization

In the fourth quarter of fiscal 2024, the ADHD market supply chain normalization led to a 13% decrease in net revenue for the ADHD portfolio. However, the second half of fiscal 2024 still saw an 8% increase in net revenue compared to the same period in the previous year, indicating resilience in demand[5].

Expert Insights and Market Impact

Dr. Sofia Muntaz, President of Lupin, emphasized the innovative formulation of Cotempla XR-ODT as a convenient option for patients, especially amid shortages of ADHD medications. This partnership is expected to enhance treatment choices and improve ADHD management and outcomes[1].

Josh Disbrow, CEO of Aytu, highlighted the underserved nature of ADHD patients globally and the potential for Aytu and Lupin to improve patient outcomes and prescription compliance while reducing therapeutic misuse[1].

Statistics and Market Data

• The Canadian ADHD stimulant market recorded 4.5 million units and $1.1 billion CAD in gross sales in 2023[1].
• Monthly prescriptions for Cotempla XR-ODT have grown by 29.6% since its launch in September 2017[3].
• Net revenue from Aytu's ADHD products increased by 31% to $15.1 million in the first quarter of fiscal 2024[2].

Future Outlook

The future outlook for Cotempla XR-ODT appears promising, driven by its unique formulation, growing prescription trends, and expanding market reach. Aytu BioPharma's strategic partnerships and focus on operational efficiencies are expected to continue driving revenue growth and improving profitability.

Key Takeaways

• Market Growth: Cotempla XR-ODT has shown significant prescription growth and revenue increases.
• Unique Formulation: It offers a convenient, once-daily orally disintegrating tablet, addressing a critical need in ADHD treatment.
• Regulatory Expansion: The product is set to enter the Canadian market, expanding Aytu's global reach.
• Financial Performance: Strong revenue growth and improving gross margins highlight the product's financial trajectory.
• Challenges: The product faces risks related to adverse reactions and market normalization.

FAQs

Q: What is Cotempla XR-ODT used for? A: Cotempla XR-ODT is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 to 17 years.

Q: What makes Cotempla XR-ODT unique? A: It is an extended-release orally disintegrating tablet, providing a convenient once-daily treatment option.

Q: How has the revenue from Cotempla XR-ODT performed? A: The revenue from Cotempla XR-ODT and other ADHD products has seen significant growth, with a 23% increase in net revenue to $57.8 million in fiscal 2024.

Q: What are the potential risks associated with Cotempla XR-ODT? A: Risks include abuse, misuse, addiction, long-term suppression of growth in pediatric patients, and worsening of tics or Tourette’s syndrome.

Q: Is Cotempla XR-ODT available in Canada? A: Not yet, but it is expected to be commercialized in Canada following regulatory approvals, anticipated within the next 18 to 24 months.

Cited Sources

1. Aytu BioPharma Announces Exclusive Agreement with Lupin Pharma Canada Ltd to Commercialize Adzenys XR-ODT and Cotempla XR-ODT in Canada. Biospace.
2. Aytu BioPharma Reports Fiscal 2024 First Quarter Financial Results. Accesswire.
3. Neos Therapeutics Reports Third Quarter 2018 Financial Results. Globenewswire.
4. Cotempla XR-ODT - accessdata.fda.gov. FDA.
5. Aytu BioPharma Reports Fiscal 2024 Full Year and Fourth Quarter Operational and Financial Results. Biospace.