REQUIP Drug Patent Profile

Which patents cover Requip, and what generic alternatives are available?

Requip is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in REQUIP 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

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

Summary for REQUIP

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	36
Patent Applications:	1,703
Drug Prices:	Drug price information for REQUIP
What excipients (inactive ingredients) are in REQUIP?	REQUIP excipients list
DailyMed Link:	REQUIP at DailyMed

See drug prices for REQUIP

See drug sales revenues for REQUIP

Recent Clinical Trials for REQUIP

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 clinical trials

Paragraph IV (Patent) Challenges for REQUIP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REQUIP	Tablets	ropinirole hydrochloride	3 mg, 4 mg and 5 mg	020658	1	2005-02-04
REQUIP	Tablets	ropinirole hydrochloride	0.25 mg, 0.5 mg, 1 mg and 2 mg	020658	1	2004-12-22

US Patents and Regulatory Information for REQUIP

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	ropinirole hydrochloride	TABLET;ORAL	020658-001	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-006	Jan 27, 1999

International Patents for REQUIP

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0113964	4-AMINOALKYL-2(3H)-INDOLONES
Mexico	9203543	MEDICAMENTO.
Hungary	T47217
Japan	S63303966	DRUG FOR TREATING PARKINSONISM

Supplementary Protection Certificates for REQUIP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0299602	C970006	Netherlands		PRODUCT NAME: ROPINIROLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT, IN HET BIJZONDER HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20761 - RVG 20765 19961202; FIRST REGISTRATION: GB PL 10592/0085 19960702
0113964	SPC/GB96/039	United Kingdom		SPC/GB96/039: 20031130, EXPIRES: 20081129
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

REQUIP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REQUIP

Introduction to REQUIP

REQUIP, also known as ropinirole, is a dopamine agonist used in the treatment of Parkinson's disease (PD) and restless legs syndrome. It is one of the key medications in the Parkinson's disease treatment market.

Market Size and Growth

The global Parkinson's disease treatment market, within which REQUIP operates, has been experiencing significant growth. In 2021, the market size was valued at USD 4.28 billion and is expected to expand at a compound annual growth rate (CAGR) of 12.1% from 2022 to 2030, reaching USD 11.98 billion by 2030[4].

Drug Class and Market Share

REQUIP falls under the dopamine agonists category, which is a substantial segment within the Parkinson's disease treatment market. Dopamine agonists, including REQUIP, accounted for a significant share of the market due to their high prescription and usage rates. The carbidopa-levodopa segment, however, remains the largest, with dopamine agonists like REQUIP contributing to the overall growth[4].

Efficacy and Clinical Trials

REQUIP has demonstrated strong efficacy in clinical trials. For instance, in a double-blind, randomized, placebo-controlled study, patients treated with REQUIP showed a 43% mean percentage improvement from baseline in the Total Motor Score, compared to 21% for the placebo group. This significant improvement highlights the drug's effectiveness in managing Parkinson's disease symptoms[5].

Competitive Landscape

The Parkinson's disease treatment market is highly competitive, with several key players including Novartis AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., GlaxoSmithKline plc., AbbVie, Inc., and H. Lundbeck A/S. REQUIP, developed by GlaxoSmithKline (now part of GSK), competes with other dopamine agonists such as Mirapex (pramipexole) and Neupro (rotigotine)[4].

Distribution Channels

REQUIP is predominantly distributed through retail pharmacies, which accounted for the largest share of the overall revenue in 2021. The ease of availability of REQUIP and other PD drugs in retail pharmacy chains like Walgreens and Walmart Stores has been a driving factor for the segment's growth. The online pharmacy segment is also expected to witness significant growth due to the convenience and discounts offered[4].

Regional Performance

North America, particularly the United States, dominates the global Parkinson's disease treatment market, with a maximum revenue share of 37.90% in 2021. This dominance is attributed to the presence of leading pharmaceutical companies and extensive research in the region. REQUIP benefits from this strong market presence in North America[4].

Financial Performance and Revenue

While specific financial data for REQUIP alone is not readily available, the drug has been a significant contributor to the revenue of its manufacturers. The success of dopamine agonists like REQUIP has helped pharmaceutical companies generate substantial revenue. For example, in the broader context, the global pharmaceutical market revenue is projected to reach $1.4 trillion by 2028, driven by the growth in chronic disease treatments, including Parkinson's disease[3].

Challenges and Opportunities

One of the major challenges for REQUIP and similar drugs is the high cost of development and the risks associated with bringing a new drug to market. The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years and a success rate of only around 10%[3].

However, the approval of novel medicines and the rising disease burden of Parkinson’s in developed countries present opportunities for growth. The emergence of new pipeline candidates and the increasing demand for dopamine agonists are expected to positively contribute to segment growth[4].

Patent Exclusivity and Generic Competition

The financial trajectory of REQUIP can be significantly impacted by patent exclusivity and the introduction of generic or biosimilar competitors. Once a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug. This can significantly impact a company's ability to recoup its R&D investment[3].

Key Takeaways

• Market Growth: The Parkinson's disease treatment market is expected to grow significantly, driven by the increasing disease burden and advancements in treatments.
• Competitive Landscape: REQUIP competes in a highly competitive market with other dopamine agonists and is distributed primarily through retail pharmacies.
• Financial Performance: While specific data for REQUIP is not available, it contributes to the overall revenue of its manufacturers within the growing pharmaceutical market.
• Challenges and Opportunities: High development costs and generic competition are challenges, but the rising demand for Parkinson’s treatments presents opportunities.

FAQs

Q: What is REQUIP used for?

A: REQUIP, or ropinirole, is used in the treatment of Parkinson's disease and restless legs syndrome.

Q: How effective is REQUIP in clinical trials?

A: REQUIP has shown significant efficacy in clinical trials, with patients experiencing a 43% mean percentage improvement from baseline in the Total Motor Score compared to 21% for the placebo group[5].

Q: What is the market size of the Parkinson's disease treatment market?

A: The global Parkinson's disease treatment market was valued at USD 4.28 billion in 2021 and is expected to reach USD 11.98 billion by 2030[4].

Q: Who are the key players in the Parkinson's disease treatment market?

A: Key players include Novartis AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., GlaxoSmithKline plc., AbbVie, Inc., and H. Lundbeck A/S[4].

Q: How does patent exclusivity affect the financial performance of REQUIP?

A: Once REQUIP loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug, significantly impacting the company's ability to recoup its R&D investment[3].

Cited Sources:

1. GlobeNewswire - Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034) | DelveInsight
2. FierceHealthcare - Study warns drug companies not to delay cancer drug launches
3. DrugBank Blog - Investment Trends in Pharmaceutical Research
4. Grand View Research - Parkinson's Disease Treatment Market Size Report, 2030
5. FDA - REQUIP® Label[5]