APTENSIO XR Drug Patent Profile

Which patents cover Aptensio Xr, and when can generic versions of Aptensio Xr launch?

Aptensio Xr is a drug marketed by Rhodes Pharms and is included in one NDA.

The generic ingredient in APTENSIO 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 Aptensio Xr

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

Summary for APTENSIO XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	4
Patent Applications:	3,710
Drug Prices:	Drug price information for APTENSIO XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APTENSIO XR
What excipients (inactive ingredients) are in APTENSIO XR?	APTENSIO XR excipients list
DailyMed Link:	APTENSIO XR at DailyMed

See drug prices for APTENSIO XR

Recent Clinical Trials for APTENSIO XR

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

Sponsor	Phase
Matthew J O'Brien, PhD, BCBA-D	Phase 4
Matthew O'Brien	Phase 4
Rhodes Pharmaceuticals, L.P.	Phase 4

See all APTENSIO XR clinical trials

Pharmacology for APTENSIO XR

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

Paragraph IV (Patent) Challenges for APTENSIO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	30 mg	205831	1	2016-03-28
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	15 mg, 20 mg, 40 mg and 50 mg	205831	1	2015-12-28
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	10 mg	205831	1	2015-12-24
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	60 mg	205831	1	2015-12-23

US Patents and Regulatory Information for APTENSIO XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-001	Apr 17, 2015	AB3	RX	Yes	No
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-007	Apr 17, 2015	AB3	RX	Yes	Yes
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-004	Apr 17, 2015	AB3	RX	Yes	No
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-002	Apr 17, 2015	AB3	RX	Yes	No

Expired US Patents for APTENSIO XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-005	Apr 17, 2015	10,463,624
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-001	Apr 17, 2015	10,463,624
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-007	Apr 17, 2015	10,463,624
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-006	Apr 17, 2015	10,463,624

International Patents for APTENSIO XR

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0035426
Japan	5186100
Spain	2586611
Japan	2012184235	CONTROL/PREPARATION RELEASE TYPE METHYLPHENIDATE ORAL PREPARATION

APTENSIO XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aptensio XR

Introduction to Aptensio XR

Aptensio XR is a long-acting, extended-release formulation of methylphenidate, a stimulant medication used to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older, as well as in adults. Here, we will delve into the market dynamics and financial trajectory of Aptensio XR.

Market Position and Competition

Aptensio XR operates within the competitive ADHD medication market, which includes both stimulant and non-stimulant treatments. The market is dominated by well-established brands such as Ritalin and newer entrants like Qelbree, a non-stimulant option launched by Supernus Pharmaceuticals[2].

Product Differentiation

Aptensio XR differentiates itself through its extended-release formulation, designed to maintain a steady level of medication in the body throughout the day. This formulation allows for once-daily dosing, which can improve adherence and reduce the need for multiple doses throughout the day[1][4].

Dosage and Administration

The medication is available in seven different dosage strengths, ranging from 10 mg to 60 mg capsules. The typical initial dose is 10 mg once daily, which can be adjusted in 10 mg increments to a maximum dose of 60 mg/day based on the patient's response and side effects[1][4].

Side Effects and Safety Profile

Common side effects of Aptensio XR include stomach pain, decreased appetite, headache, and trouble sleeping. More serious side effects can include increased blood pressure, heart rate, and circulation problems. The risk of abuse and overdose is also a significant concern due to the habit-forming nature of the drug[1][4].

Market Performance and Sales

Aptensio XR, like other ADHD medications, benefits from the growing demand for treatments in this space. The ADHD market is substantial, with the adult segment representing about 50% to 60% of the total market[2].

While specific sales figures for Aptensio XR are not readily available, the broader context of the ADHD market suggests a robust financial performance. For instance, Supernus Pharmaceuticals, which also operates in the ADHD space with Qelbree, reported record revenues of approximately $580 million in 2021, up 11% from 2020[2].

Pricing and Cost Considerations

The cost of Aptensio XR can be significant, with a 90-capsule supply of 10 mg capsules costing approximately $628 if paid in cash. However, the generic version, methylphenidate hydrochloride, can be less expensive, offering a more affordable alternative for patients[1].

Financial Trajectory

The financial trajectory of Aptensio XR is influenced by several factors, including market demand, competition, and regulatory approvals.

• Market Growth: The ADHD market is expected to continue growing, driven by increasing awareness and diagnosis rates. This growth bodes well for Aptensio XR and other ADHD medications.
• Competitive Landscape: The entry of new treatments, such as Qelbree, introduces competition but also expands the overall market size by offering more treatment options[2].
• Regulatory Environment: Regulatory approvals and any changes in FDA guidelines can impact the sales and market position of Aptensio XR. For example, the approval of Qelbree for adult use in 2022 expanded the market opportunities for non-stimulant ADHD treatments[2].

Strategic Initiatives and Future Outlook

Pharmaceutical companies like Supernus, which operate in the ADHD space, are continually looking for strategic initiatives to enhance their market position.

• Product Diversification: Companies are diversifying their portfolios by acquiring new assets and developing novel treatments. For instance, Supernus acquired Adamas Pharmaceuticals to strengthen its CNS and movement disorder portfolio[2].
• Research and Development: Ongoing R&D efforts are crucial for maintaining a competitive edge. Supernus has several product candidates in various stages of development, including SPN-820 for treatment-resistant depression and SPN-443 and SPN-446 for CNS indications[2].

Key Takeaways

• Market Position: Aptensio XR is a significant player in the ADHD medication market, offering a long-acting, extended-release formulation.
• Financial Performance: The drug benefits from a growing ADHD market, although specific sales figures are not publicly disclosed.
• Pricing and Cost: The medication is relatively expensive, but generic alternatives can offer cost savings.
• Future Outlook: The financial trajectory is influenced by market growth, competition, and regulatory approvals.

FAQs

1. What is Aptensio XR used for? Aptensio XR is used to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older, as well as in adults[1][4].

2. How does Aptensio XR work? Aptensio XR is designed to release 40% of the active ingredient within an hour after taking, and the remaining 60% is released throughout the day, maintaining a steady level of medication[1].

3. What are the common side effects of Aptensio XR? Common side effects include stomach pain, decreased appetite, headache, and trouble sleeping. More serious side effects can include increased blood pressure and circulation problems[1][4].

4. How much does Aptensio XR cost? A 90-capsule supply of 10 mg Aptensio XR capsules costs approximately $628 if paid in cash. Generic versions can be less expensive[1].

5. Is Aptensio XR habit-forming? Yes, Aptensio XR is habit-forming and carries a risk of abuse and overdose due to its stimulant properties[1][4].

Sources

1. HealthCentral - What You Need to Know About Aptensio (methylphenidate)
2. Supernus Pharmaceuticals - Dear Supernus Stockholder, 2021 was another outstanding year for ...
3. Supernus Pharmaceuticals - 25MAR201519494405 - Supernus Pharmaceuticals
4. ADDitude - Aptensio XR: ADHD Stimulant Medication Overview