KAPVAY Drug Patent Profile

When do Kapvay patents expire, and what generic alternatives are available?

Kapvay is a drug marketed by Concordia Pharms Inc and is included in one NDA.

The generic ingredient in KAPVAY is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kapvay

A generic version of KAPVAY was approved as clonidine hydrochloride by ACTAVIS ELIZABETH on December 16^th, 1986.

Summary for KAPVAY

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	6
Patent Applications:	1,871
Drug Prices:	Drug price information for KAPVAY
What excipients (inactive ingredients) are in KAPVAY?	KAPVAY excipients list
DailyMed Link:	KAPVAY at DailyMed

See drug prices for KAPVAY

See drug sales revenues for KAPVAY

Recent Clinical Trials for KAPVAY

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

Sponsor	Phase
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	Phase 4
Mihaela Visoiu	N/A

See all KAPVAY clinical trials

Paragraph IV (Patent) Challenges for KAPVAY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KAPVAY	Extended-release Tablets	clonidine hydrochloride	0.1 mg and 0.2 mg	022331	1	2011-03-04

US Patents and Regulatory Information for KAPVAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010		DISCN	Yes	No
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010		DISCN	Yes	No

Expired US Patents for KAPVAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-003	Sep 28, 2010	5,869,100
Concordia Pharms Inc	KAPVAY	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022331-004	Sep 28, 2010	5,869,100

International Patents for KAPVAY

See the table below for patents covering KAPVAY around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69534283
Australia	5259396
European Patent Office	0805677	PREPARATION DE CLONIDINE A LIBERATION PROLONGEE (EXTENDED RELEASE CLONIDINE FORMULATION)

KAPVAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KAPVAY

Introduction to KAPVAY

KAPVAY, an extended-release formulation of clonidine hydrochloride, is a significant player in the Attention Deficit Hyperactivity Disorder (ADHD) treatment market. It is the first and only FDA-approved ADHD treatment indicated for use as both monotherapy and as add-on therapy to stimulant medications[1].

Market Need and Demand

ADHD affects a substantial portion of the U.S. population, with over 4.5 million children and at least 7% of school-aged children suffering from the condition. The need for effective treatments is high, especially since up to 30% of ADHD patients do not achieve optimal symptom relief from stimulant monotherapy alone[1].

Competitive Landscape

The ADHD treatment market is competitive, with various medications available, including stimulants and non-stimulants. KAPVAY stands out due to its unique indication as an add-on therapy to stimulants, offering an alternative for patients who do not respond adequately to stimulants alone. Other companies, such as Supernus Pharmaceuticals with Qelbree, also compete in this space, but KAPVAY's extended-release formulation and specific indications set it apart[1][5].

Regulatory Approval and Clinical Trials

KAPVAY's FDA approval was based on two Phase III studies that demonstrated significant efficacy in children and adolescents with ADHD. These studies evaluated symptoms using the ADHD Rating Scale-IV-Parent Version (ADHDRS-IV) and showed that KAPVAY was effective in reducing hyperactive/impulsivity and inattentive subscales[1].

Safety and Adverse Events

While KAPVAY has shown efficacy, it also comes with potential adverse events such as somnolence, fatigue, and hypotension. Post-marketing surveillance has not identified new safety signals, but the drug's label includes warnings for hypotension, bradycardia, and syncope, particularly in patients with cardiovascular or renal conditions[3].

Commercial Availability and Pricing

KAPVAY was commercially available in the U.S. starting in January 2011. The market for clonidine hydrochloride extended-release tablets has seen competition from generic versions, such as the one launched by Upsher-Smith in 2020, which is AB1-rated to the branded KAPVAY product. The generic competition can impact pricing and market share[1][4].

Financial Performance and Market Size

The clonidine hydrochloride extended-release tablet market had U.S. sales of approximately $30 million for the 12 months ending November 2019. While specific financial data for KAPVAY alone is not readily available, the presence of generic competitors and the overall ADHD treatment market dynamics suggest that the financial trajectory for KAPVAY would be influenced by competition and market demand[4].

Generic Competition and Impact

The introduction of generic versions, such as Upsher-Smith's clonidine hydrochloride extended-release tablets, can significantly impact the financial performance of the branded product. Generic competition often leads to reduced prices and market share for the original brand, which could affect KAPVAY's revenue[4].

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of ADHD treatments. KAPVAY's unique indication as an add-on therapy and its extended-release formulation may maintain its appeal to prescribers looking for alternative treatment options. However, the availability of generics and other treatment options can influence these preferences[1].

Future Outlook and Market Trends

The ADHD treatment market is expected to continue growing, driven by increasing prescription rates and the need for effective treatments. Companies like Supernus Pharmaceuticals are focusing on expanding their ADHD product portfolios, which could influence the market share of existing treatments like KAPVAY. The introduction of new technologies, such as Cingulate's Precision Timed Release (PTR) technology, may also shape the future of ADHD treatment and potentially impact KAPVAY's market position[2][5].

Key Takeaways

• Unique Indication: KAPVAY is the first FDA-approved ADHD treatment for use as both monotherapy and add-on therapy to stimulants.
• Market Demand: High demand due to the prevalence of ADHD and the need for alternative treatments.
• Regulatory Approval: Approved based on Phase III studies demonstrating efficacy.
• Safety Considerations: Potential adverse events include somnolence, fatigue, and hypotension.
• Commercial and Financial Impact: Affected by generic competition and overall market dynamics.
• Future Outlook: Continued growth in the ADHD treatment market, with potential impact from new technologies and treatments.

Frequently Asked Questions

Q: What is KAPVAY used for?

A: KAPVAY is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents, both as monotherapy and as add-on therapy to stimulant medications.

Q: How was KAPVAY approved?

A: KAPVAY was approved by the FDA based on two Phase III studies that demonstrated its efficacy in reducing ADHD symptoms.

Q: What are the common side effects of KAPVAY?

A: Common side effects include somnolence, fatigue, and hypotension. The drug also carries warnings for bradycardia, syncope, and cardiovascular risks.

Q: Is KAPVAY available in generic form?

A: Yes, generic versions of clonidine hydrochloride extended-release tablets are available, such as the one launched by Upsher-Smith.

Q: How does KAPVAY fit into the broader ADHD treatment market?

A: KAPVAY is a unique player due to its indication as an add-on therapy to stimulants, but it faces competition from other ADHD treatments and generic versions.

Cited Sources:

1. Shionogi Inc. - KAPVAY™ (clonidine hydrochloride) Extended-Release Tablets for the Treatment of ADHD.
2. Zacks Small-Cap Research - Cingulate’s Candidates and Financial Statements.
3. FDA - Kapvay® (clonidine extended-release) tablets.
4. Upsher-Smith - Clonidine Hydrochloride Extended-Release Tablets.
5. Supernus Pharmaceuticals - 2023 Performance and Future Outlook.