QUILLICHEW ER Drug Patent Profile

When do Quillichew Er patents expire, and when can generic versions of Quillichew Er launch?

Quillichew Er is a drug marketed by Nextwave Pharms and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in fourteen countries.

The generic ingredient in QUILLICHEW ER 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 Quillichew Er

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

Summary for QUILLICHEW ER

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	1
Patent Applications:	3,710
Drug Prices:	Drug price information for QUILLICHEW ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUILLICHEW ER
What excipients (inactive ingredients) are in QUILLICHEW ER?	QUILLICHEW ER excipients list
DailyMed Link:	QUILLICHEW ER at DailyMed

See drug prices for QUILLICHEW ER

Recent Clinical Trials for QUILLICHEW ER

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

Sponsor	Phase
Pfizer	Phase 4

See all QUILLICHEW ER clinical trials

Pharmacology for QUILLICHEW ER

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

Paragraph IV (Patent) Challenges for QUILLICHEW ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUILLICHEW ER	Extended-release Chewable Tablets	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	207960	1	2016-04-25

US Patents and Regulatory Information for QUILLICHEW ER

QUILLICHEW ER is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	8,999,386		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	8,287,903		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	9,295,642		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No	11,103,494		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	11,103,495		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	11,103,494		Y

International Patents for QUILLICHEW ER

See the table below for patents covering QUILLICHEW ER around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2435569	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
South Korea	20080108520	MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Austria	E536867

QUILLICHEW ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QuilliChew ER

Introduction to QuilliChew ER

QuilliChew ER, developed by Tris Pharma and marketed by Pfizer, is an extended-release, chewable tablet formulation of methylphenidate hydrochloride. It is specifically designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and above. This innovative formulation marks a significant advancement in ADHD treatment, offering a unique chewable option that can be taken with or without food[1].

Regulatory Approvals and Global Expansion

QuilliChew ER has received several regulatory approvals that have expanded its global availability. Initially approved by the U.S. FDA in 2015, it has since gained approvals in various countries including Canada, China, Israel, and most recently, Saudi Arabia. These approvals underscore the growing global recognition of the need for long-acting ADHD therapies that can be tailored to individual patient needs[2][4].

Market Need and Demand

The global ADHD market is experiencing significant growth, driven by increased awareness and improved diagnostic practices. It is estimated that approximately 129 million children and adolescents aged 5-19, and more than 366 million adults worldwide, have ADHD. This rising prevalence creates a substantial demand for effective and versatile treatment options like QuilliChew ER[4].

Unique Selling Points

QuilliChew ER offers several unique advantages that contribute to its market appeal:

• Extended-Release Formulation: QuilliChew ER provides a long-lasting effect, with efficacy demonstrated from 45 minutes through an 8-hour duration post-dosing. This consistent delivery profile helps in managing ADHD symptoms throughout the day[1][4].
• Chewable Tablets: The chewable format makes it easier for pediatric patients to take, especially those who have difficulty swallowing traditional tablets. The scored tablets also allow for flexible dosing options[1][4].
• Personalized Dosing: The availability of multiple dosage strengths (20 mg scored, 30 mg scored, and 40 mg unscored) enables healthcare professionals to individualize the dose according to the patient's specific needs[1].

Clinical Efficacy

The efficacy of QuilliChew ER was evaluated in a double-blind, randomized, placebo-controlled study involving 90 children aged 6 to 12 years with ADHD. The study demonstrated significant improvements in attention and behavior compared to placebo, with effects measurable at various time points post-dosing[1].

Safety and Adverse Reactions

While QuilliChew ER has shown significant clinical efficacy, it also comes with potential risks and side effects. Common adverse reactions include decreased appetite, aggression, emotional poverty, nausea, headache, and weight decrease. Additionally, CNS stimulants like QuilliChew ER have a high potential for abuse and dependence, and they can also cause cardiovascular effects, peripheral vasculopathy, and other serious side effects[1][2][3].

Financial Trajectory

The financial trajectory of QuilliChew ER is influenced by several factors:

• Market Penetration: With expanding global approvals, QuilliChew ER is poised to capture a larger share of the ADHD treatment market. The drug's unique features and the growing demand for ADHD therapies are likely to drive sales[2][4].
• Competitive Landscape: The ADHD market is competitive, but QuilliChew ER's chewable and extended-release formulation sets it apart from other treatments. This differentiation can help in attracting a significant patient base and generating substantial revenue[4].
• Partnerships and Distribution: Tris Pharma is actively seeking partnerships to facilitate the distribution of QuilliChew ER in new markets. Such partnerships can enhance the drug's availability and contribute to its financial success[4].

Future Outlook

The future outlook for QuilliChew ER appears promising due to several factors:

• Increasing ADHD Prevalence: The rising global prevalence of ADHD ensures a growing market for effective treatments.
• Expanding Global Reach: Additional regulatory approvals in various countries will continue to expand the drug's market reach.
• Innovative Formulation: The unique chewable and extended-release formulation of QuilliChew ER positions it as a preferred option for many patients and healthcare providers.

Key Takeaways

• QuilliChew ER is an extended-release, chewable methylphenidate hydrochloride tablet approved for ADHD treatment in patients aged 6 and above.
• The drug has received multiple global regulatory approvals, expanding its market reach.
• It offers a unique formulation with flexible dosing options and a long-lasting effect.
• Despite potential side effects and risks, QuilliChew ER has demonstrated significant clinical efficacy.
• The financial trajectory is positive, driven by market demand, unique selling points, and expanding global availability.

FAQs

Q: What is QuilliChew ER used for? A: QuilliChew ER is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and above.

Q: What makes QuilliChew ER unique? A: QuilliChew ER is the first and only long-acting, chewable methylphenidate treatment for ADHD, offering flexible dosing options and a long-lasting effect.

Q: What are the common side effects of QuilliChew ER? A: Common side effects include decreased appetite, aggression, emotional poverty, nausea, headache, and weight decrease.

Q: Is QuilliChew ER available globally? A: Yes, QuilliChew ER has received regulatory approvals in several countries including the U.S., Canada, China, Israel, and Saudi Arabia.

Q: What are the potential risks associated with QuilliChew ER? A: QuilliChew ER has a high potential for abuse and dependence, and it can cause serious cardiovascular effects, peripheral vasculopathy, and other side effects.

Sources

1. Pfizer: Pfizer Receives U.S. FDA Approval of New QuilliChew ER™ (methylphenidate hydrochloride) extended-release chewable tablets CII.
2. Tris Pharma: Tris Pharma Secures Additional ex-US Approvals to Expand Global Availability of Quillivant XR and QuilliChew ER for the Treatment of Attention Deficit Hyperactivity Disorder.
3. FDA: QuilliChew ER - accessdata.fda.gov.
4. Business Wire: Tris Pharma Secures Additional ex-US Approvals to Expand Global Availability of Quillivant XR and QuilliChew ER for the Treatment of Attention Deficit Hyperactivity Disorder.