ADHANSIA XR Drug Patent Profile

Which patents cover Adhansia Xr, and what generic alternatives are available?

Adhansia Xr is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twelve patents protecting this drug.

This drug has thirty-three patent family members in seventeen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adhansia Xr

A generic version of ADHANSIA XR was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for ADHANSIA XR

International Patents:	33
US Patents:	12
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	2
Patent Applications:	3,740
Drug Prices:	Drug price information for ADHANSIA XR
What excipients (inactive ingredients) are in ADHANSIA XR?	ADHANSIA XR excipients list
DailyMed Link:	ADHANSIA XR at DailyMed

See drug prices for ADHANSIA XR

Recent Clinical Trials for ADHANSIA XR

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

Sponsor	Phase
Purdue Pharma LP	Phase 4

See all ADHANSIA XR clinical trials

US Patents and Regulatory Information for ADHANSIA XR

ADHANSIA XR is protected by twelve US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	10,292,939		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,512,613
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,568,841		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	10,512,612		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,722,473

International Patents for ADHANSIA XR

See the table below for patents covering ADHANSIA XR around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201702716	METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER
Canada	2936740
Canada	2902911	METHODES ET COMPOSITIONS DESTINEES AU TRAITEMENT DU TROUBLE DE DEFICIT D'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
Singapore	10201912626W	METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER
China	107205954
European Patent Office	3212172	MÉTHODES ET COMPOSITIONS DESTINÉES EN PARTICULIER AU TRAITEMENT DU TROUBLE DÉFICITAIRE DE L'ATTENTION (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)

ADHANSIA XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ADHANSIA XR

Introduction

ADHANSIA XR, a methylphenidate hydrochloride extended-release capsule, was approved by the FDA in February 2019 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth

The North American ADHD therapeutics market, which includes ADHANSIA XR, is projected to grow significantly. By 2032, the market is expected to reach $7.29 billion, up from $4.18 billion in 2024, with a Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period[1].

Geographical Dominance

The North American region, particularly the U.S., dominates the global ADHD therapeutics market. In 2023, this region held around 36% of the global market share, driven by a well-developed economy, early adoption of sophisticated technology, and high per capita healthcare costs[1].

Product Approval and Availability

ADHANSIA XR was approved by the FDA in February 2019 and was initially available throughout the U.S. The medication is designed with multilayered beads, including an immediate release layer and 20% of the methylphenidate dose, to provide extended-release benefits[2][4].

Clinical Efficacy

Clinical studies have shown that ADHANSIA XR is effective in treating ADHD. A double-blind, randomized, placebo-controlled crossover study in an adult workplace environment demonstrated statistically significant improvements in performance scores compared to placebo. The medication showed efficacy at various time points post-dose, highlighting its duration of action[2].

Safety and Adverse Reactions

While ADHANSIA XR has been effective, it also comes with potential adverse reactions. Common adverse reactions in adults include insomnia, dry mouth, nausea, and decreased appetite. In pediatric patients, decreased appetite, insomnia, and weight loss are notable. The medication was also associated with serious unlabeled adverse events, leading to its withdrawal from the market effective January 9, 2023[3].

Financial Performance

Despite its clinical efficacy, the financial performance of ADHANSIA XR was impacted by its recent market withdrawal. The withdrawal was due to safety concerns and the applicant's request to the FDA. Prior to its withdrawal, ADHANSIA XR was part of a growing ADHD treatment market, which is expected to continue expanding with other treatments[3][4].

Market Drivers

Several factors drive the ADHD therapeutics market, including ADHANSIA XR before its withdrawal:

• Rising Awareness: Increased awareness among physicians and patients about ADHD has driven market growth.
• Lifestyle Factors: Unstable lifestyles and dietary factors, such as preservatives in children's meals, contribute to the rising incidence of ADHD.
• Medical Developments: Advances in neuroscience research and public awareness about mental health issues also boost market growth[1].

Competitive Landscape

The ADHD treatment market is competitive, with several other medications available. For instance, Supernus Pharmaceuticals launched Qelbree, a novel non-stimulant treatment for ADHD, which has been gaining traction. Other treatments like Oxtellar XR and Trokendi XR from Supernus also compete in the broader CNS market[5].

Future Outlook

Although ADHANSIA XR is no longer available, the ADHD treatment market continues to grow. New treatments and ongoing research are expected to drive this growth. The global ADHD treatment market is projected to reach $35,068.1 million by 2030, with a CAGR of 7.1% from 2022 to 2030[4].

Key Takeaways

• Market Growth: The North American ADHD therapeutics market is expected to grow significantly, driven by increasing awareness and medical developments.
• Product Efficacy: ADHANSIA XR showed clinical efficacy in treating ADHD but was withdrawn due to safety concerns.
• Competitive Market: The ADHD treatment market is highly competitive with various treatments available.
• Future Prospects: The market is expected to continue growing with new treatments and ongoing research.

FAQs

Q: What is ADHANSIA XR, and what was it used for? A: ADHANSIA XR is a methylphenidate hydrochloride extended-release capsule used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older.

Q: Why was ADHANSIA XR withdrawn from the market? A: ADHANSIA XR was withdrawn from the market effective January 9, 2023, due to safety concerns and the applicant's request to the FDA.

Q: What are the common adverse reactions associated with ADHANSIA XR? A: Common adverse reactions include insomnia, dry mouth, nausea, and decreased appetite in adults, and decreased appetite, insomnia, and weight loss in pediatric patients.

Q: How does ADHANSIA XR compare to other ADHD treatments in terms of efficacy? A: ADHANSIA XR demonstrated statistically significant improvements in performance scores compared to placebo in clinical studies, but its efficacy is now moot due to its market withdrawal.

Q: What is the projected growth of the ADHD treatment market? A: The global ADHD treatment market is expected to reach $35,068.1 million by 2030, with a CAGR of 7.1% from 2022 to 2030.

Sources

1. Marketdataforecast.com: North America ADHD Therapeutics Market Report | 2024 to 2032
2. Businesswire.com: Adhansia XR™ (methylphenidate HCl) Extended Release Capsules ...
3. FDA.gov: ADHANSIA XR PAC REVIEW 2023 - FDA
4. Coherentmarketinsights.com: Attention Deficit Hyperactivity Disorder Treatment Market
5. Supernus.com: Dear Supernus Stockholder, 2021 was another outstanding year for ...