REQUIP XL Drug Patent Profile

When do Requip Xl patents expire, and when can generic versions of Requip Xl launch?

Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Requip Xl

A generic version of REQUIP XL was approved as ropinirole hydrochloride by PRINSTON INC on May 5^th, 2008.

Summary for REQUIP XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	36
Patent Applications:	1,703
Drug Prices:	Drug price information for REQUIP XL
DailyMed Link:	REQUIP XL at DailyMed

See drug prices for REQUIP XL

Recent Clinical Trials for REQUIP XL

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

Sponsor	Phase
Titan Pharmaceuticals	Phase 1/Phase 2
Vanderbilt University Medical Center	Phase 4
Seoul National University Hospital	Phase 4

See all REQUIP XL clinical trials

Paragraph IV (Patent) Challenges for REQUIP XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	6 mg	022008	1	2009-07-14
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	12 mg	022008	1	2009-02-05
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	3 mg	022008	1	2009-01-08
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	8 mg	022008	1	2008-11-03
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	4 mg	022008	1	2008-10-31
REQUIP XL	Extended-release Tablets	ropinirole hydrochloride	2 mg	022008	1	2008-10-14

US Patents and Regulatory Information for REQUIP XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008		DISCN	Yes	No

Expired US Patents for REQUIP XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009	5,422,123
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008	7,927,624
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008	7,927,624
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-002	Jun 13, 2008	7,927,624
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-003	Jun 13, 2008	8,303,986
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-001	Jun 13, 2008	5,422,123

International Patents for REQUIP XL

See the table below for patents covering REQUIP XL around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	030557	UNA TABLETA EN MULTICAPA DE LIBERACION CONTROLADA Y METODO DE TRATAMIENTO
Poland	365837
Mexico	PA02010151	FORMULACION DE DOSIFICACION DE MATRIZ POLIMERICA HIDROFILICA/LIPOFILICA. (HYDROPHILIC LIPOPHILIC POLYMERIC MATRIX DOSAGE FORMULATION.)
New Zealand	521902	Hydrophilic/lipophilic polymeric matrix dosage formulation
Japan	H06172162	TABLET PROVIDED WITH RELEASE OF ACTIVE SUBSTANCE WITH CONTROLLED SPEED
Germany	69026215

Supplementary Protection Certificates for REQUIP XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299602	SPC/GB96/040	United Kingdom		PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0299602	97C0036	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702

REQUIP XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REQUIP XL

Introduction

REQUIP XL, a non-ergoline dopamine agonist, is a crucial medication in the treatment of Parkinson’s disease and, until its discontinuation, restless legs syndrome (RLS). This article delves into the market dynamics and financial trajectory of REQUIP XL, highlighting key factors that influenced its performance.

Indications and Usage

REQUIP XL is primarily indicated for the treatment of Parkinson’s disease. It is designed as an extended-release formulation, allowing for once-daily dosing, which enhances patient compliance and convenience[4].

Market Position

REQUIP XL, developed by GlaxoSmithKline (GSK), was a significant player in the Parkinson’s disease treatment market. It was one of the preferred dopamine agonists, recommended by clinical guidelines for its efficacy in managing symptoms of Parkinson’s disease[1].

Sales Performance

Early Success

In its early years, REQUIP XL saw substantial sales growth. The drug was approved in 1997, and by the mid-2000s, it had become a key contributor to GSK’s pharmaceutical portfolio. For instance, in 2007, GSK reported strong sales across its pharmaceutical products, including REQUIP, although specific figures for REQUIP XL were not isolated[3].

Impact of Generic Competition

However, the sales of REQUIP XL began to decline significantly with the advent of generic competition. By 2012, GSK reported a 22% decline in REQUIP sales due to generic versions entering the market[2].

Financial Trajectory

Revenue Contributions

REQUIP XL was a notable revenue generator for GSK. However, its financial performance was heavily impacted by generic competition and other market factors. In 2012, despite overall flat sales for GSK, the decline in REQUIP sales was a significant factor in the pharmaceutical division's performance[2].

Cost Management and Efficiency

GSK implemented various cost management strategies to mitigate the impact of declining sales. These included operational efficiencies, reduced R&D expenditure, and one-off benefits such as pension savings. Despite these efforts, the decline in REQUIP sales continued to affect the company's financial performance[2].

Discontinuation of Certain Dosages

In 2019, GSK announced the discontinuation of all dosage strengths of ropinirole (Requip) tablets and the 2-mg extended-release (Requip XL) tablets. This decision was attributed to a "business decision" rather than any safety or efficacy concerns. The discontinuation did not affect the 4-mg, 6-mg, 8-mg, and 12-mg tablets of Requip XL[1].

Market Impact of Discontinuation

The discontinuation of certain dosages of REQUIP XL had several implications:

• Patient Transition: Patients on the discontinued dosages had to be transitioned to other available dosages or alternative treatments, which could have been challenging for some patients.
• Market Share: The discontinuation likely affected GSK's market share in the Parkinson’s disease treatment segment, although the impact was mitigated by the continued availability of higher dosages of Requip XL[1].

Competitive Landscape

The Parkinson’s disease treatment market is highly competitive, with several dopamine agonists and other classes of drugs available. REQUIP XL faced competition from other branded and generic dopamine agonists, such as pramipexole, which is also recommended for treating Parkinson’s disease and RLS[1].

Regulatory and Safety Considerations

REQUIP XL has been subject to various regulatory updates and safety warnings. For example, in 2020, the FDA updated the warnings and precautions section to include hallucinations, psychotic-like behavior, and impulse control/compulsive behaviors. These updates are crucial for patient safety but can also impact prescribing habits and market dynamics[4].

Financial Outlook

The financial outlook for REQUIP XL, post-discontinuation of certain dosages, is complex. While GSK continues to generate revenue from the remaining dosages, the overall sales trajectory is likely to be influenced by the competitive landscape and the availability of generic alternatives.

Key Takeaways

• Market Position: REQUIP XL was a significant player in the Parkinson’s disease treatment market but faced declining sales due to generic competition.
• Financial Performance: The drug contributed substantially to GSK’s revenue but saw a decline in sales over the years.
• Discontinuation: The discontinuation of certain dosages was a business decision and did not affect all available dosages.
• Regulatory Updates: Safety warnings and regulatory updates continue to shape the drug’s market dynamics.
• Competitive Landscape: The Parkinson’s disease treatment market remains highly competitive, with multiple treatment options available.

FAQs

What is REQUIP XL used for?

REQUIP XL is a non-ergoline dopamine agonist used primarily for the treatment of Parkinson’s disease.

Why was REQUIP XL discontinued in certain dosages?

The discontinuation of certain dosages of REQUIP XL was due to a business decision made by GlaxoSmithKline.

How does REQUIP XL compare to other dopamine agonists?

REQUIP XL is one of the recommended dopamine agonists for Parkinson’s disease, similar to pramipexole, but its market position has been affected by generic competition.

What are the common side effects of REQUIP XL?

Common side effects include somnolence, hallucinations, and impulse control/compulsive behaviors. Patients should be monitored for these adverse reactions.

How has generic competition impacted REQUIP XL sales?

Generic competition has significantly impacted REQUIP XL sales, leading to a decline in revenue for GSK.

Sources

1. American Academy of Sleep Medicine: GSK to discontinue RLS treatment ropinirole, maintain extended release formulations.
2. GlaxoSmithKline: Q4 2012 Results Announcement.
3. GlaxoSmithKline: 20 F 2007.
4. Drugs.com: REQUIP XL Package Insert / Prescribing Information.