ROPINIROLE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for ropinirole hydrochloride and what is the scope of freedom to operate?

Ropinirole hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Alembic, Chartwell Rx, Dr Reddys Labs Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Watson Labs Inc, Accord Hlthcare, Alembic Ltd, Cosette, Epic Pharma Llc, Glenmark Pharms Ltd, Hikma, MLV, Norvium Bioscience, Orbion Pharms, and Zydus Lifesciences, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for ropinirole hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for ROPINIROLE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	22
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	74
Patent Applications:	2,696
What excipients (inactive ingredients) are in ROPINIROLE HYDROCHLORIDE?	ROPINIROLE HYDROCHLORIDE excipients list
DailyMed Link:	ROPINIROLE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ROPINIROLE HYDROCHLORIDE

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

Sponsor	Phase
Hoffmann-La Roche	Phase 1
Population Health Research Institute	Phase 3
University of Alberta	Phase 2

See all ROPINIROLE HYDROCHLORIDE clinical trials

Pharmacology for ROPINIROLE HYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ROPINIROLE HYDROCHLORIDE

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for ROPINIROLE HYDROCHLORIDE

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
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 ROPINIROLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090869-002	May 17, 2012	AB	RX	No	No
Glenmark Pharms Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	090135-006	Feb 25, 2010	AB	RX	No	No
Dr Reddys Labs Ltd	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201576-002	Jun 6, 2012	AB	RX	No	No
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-005	Sep 19, 1997		DISCN	Yes	No

Expired US Patents for ROPINIROLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-003	Sep 19, 1997
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-006	Apr 10, 2009
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-005	Oct 31, 2008
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-002	Sep 19, 1997

ROPINIROLE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ropinirole Hydrochloride

Overview of Ropinirole Hydrochloride

Ropinirole hydrochloride, marketed under the brand name Requip, is a dopamine agonist used primarily for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The Parkinson's disease market, which includes ropinirole hydrochloride, is expected to exhibit significant growth. According to DelveInsight, the Parkinson's disease market in the 7MM (the United States, EU-4, the United Kingdom, and Japan) was valued at USD 3.2 billion in 2023 and is projected to grow at a CAGR of 5.8% from 2020 to 2034[1].

Key Market Drivers

Advancements in Diagnostic Techniques and Treatment Options

Advancements in diagnostic techniques and the emergence of new treatment options are driving the growth of the Parkinson's disease market. Ropinirole hydrochloride, being a key player in this market, benefits from these advancements. New diagnostic methods and biomarker research enable earlier detection and intervention, potentially slowing disease progression and increasing the demand for effective treatments like ropinirole[1].

Increasing Prevalence of Parkinson's Disease

The rising prevalence of Parkinson's disease, particularly among an aging population, creates a larger target market for ropinirole hydrochloride. In 2023, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM, with the United States accounting for 45% of these cases[1].

Robust Pipeline of Emerging Therapies

The current pipeline for Parkinson's disease treatments is robust, with several late-stage drugs expected to enter the market during the forecast period. While ropinirole hydrochloride is an established treatment, the introduction of new therapies can influence market dynamics and potentially impact the market share of existing treatments[1].

Cost-Effectiveness and Pharmacoeconomic Profile

Economic Evaluation

Studies have shown that ropinirole prolonged release (PR) has a favorable pharmacoeconomic profile compared to the immediate release (IR) formulation. In the Netherlands, ropinirole PR was found to be cost-saving or cost-effective due to its ability to reduce disease progression and lower dyskinesia rates, leading to improved quality of life and medication adherence[2].

Clinical Outcomes and Quality of Life

Ropinirole hydrochloride has demonstrated significant improvements in clinical outcomes for patients with Parkinson's disease and RLS. For instance, in clinical trials, ropinirole PR showed a greater improvement in time spent 'off' compared to the IR formulation, enhancing the quality of life for patients[2].

Market Competition and Key Players

Prominent Companies

Several pharmaceutical companies are actively involved in the development and marketing of Parkinson's disease treatments, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, and AbbVie. These companies are working on innovative therapies that could impact the market share of established drugs like ropinirole hydrochloride[1].

Generic and Branded Competition

The market for ropinirole hydrochloride faces competition from both generic and branded alternatives. The expiration of patents for branded drugs can lead to the entry of generic versions, which can affect the pricing and market share of the original branded product.

Regulatory and Pharmacokinetic Considerations

Regulatory Approvals

Ropinirole hydrochloride is approved by regulatory bodies such as the US FDA for the treatment of Parkinson's disease and RLS. The drug's regulatory status is crucial for its market presence and sales[5].

Pharmacokinetics and Metabolism

Ropinirole hydrochloride is extensively metabolized by the liver and has a linear pharmacokinetic profile over its therapeutic dosing range. This metabolism can be affected in patients with hepatic impairment, requiring cautious dose titration in such cases[5].

Patient Populations and Dosing

Specific Patient Populations

The drug's dosing and administration vary based on the patient population. For RLS, the initial dose is typically 0.25 mg once daily, incrementing based on patient tolerability and therapeutic response. For patients with renal impairment, dose adjustments may be necessary, and for those with hepatic impairment, caution is advised due to the drug's metabolism in the liver[3].

Adverse Effects and Monitoring

Patients on ropinirole hydrochloride need to be monitored for adverse effects such as orthostatic hypotension, somnolence, and compulsive behaviors. The drug's side effect profile can influence patient compliance and overall market acceptance[3].

Financial Trajectory

Revenue and Market Share

In 2023, the majority of the Parkinson's disease market revenue came from combination therapies and other treatments, with a revenue of USD 2.2 billion. Ropinirole hydrochloride, as a part of this market, contributes significantly to these revenues, although the exact share can fluctuate based on the introduction of new therapies and generic competition[1].

Future Projections

Given the projected growth of the Parkinson's disease market, ropinirole hydrochloride is expected to continue generating substantial revenue. However, the financial trajectory will be influenced by the approval and market entry of new treatments, as well as changes in patient demographics and treatment preferences.

Key Takeaways

• Market Growth: The Parkinson's disease market, including ropinirole hydrochloride, is expected to grow at a CAGR of 5.8% from 2020 to 2034.
• Cost-Effectiveness: Ropinirole PR has a favorable pharmacoeconomic profile, offering cost savings and improved quality of life.
• Competition: The market faces competition from emerging therapies and generic alternatives.
• Regulatory and Pharmacokinetic Considerations: The drug's regulatory status and pharmacokinetic profile are crucial for its market presence and patient safety.
• Patient Populations and Dosing: Dosing varies based on patient populations, and monitoring for adverse effects is essential.

FAQs

What is the primary use of ropinirole hydrochloride?

Ropinirole hydrochloride is primarily used for the treatment of Parkinson's disease and restless legs syndrome.

How does the pharmacoeconomic profile of ropinirole PR compare to ropinirole IR?

Ropinirole PR has a more favorable pharmacoeconomic profile compared to ropinirole IR, offering cost savings and improved quality of life due to reduced disease progression and lower dyskinesia rates[2].

What are the key drivers of the Parkinson's disease market growth?

The growth is driven by advancements in diagnostic techniques, increased awareness, rising prevalence of Parkinson's disease, and the introduction of new treatment options[1].

How does ropinirole hydrochloride's market share compare to other treatments in the Parkinson's disease market?

In 2023, the majority of the Parkinson's disease market revenue came from combination therapies and other treatments, with ropinirole hydrochloride contributing significantly but facing competition from emerging therapies[1].

What are the potential side effects of ropinirole hydrochloride that require monitoring?

Patients on ropinirole hydrochloride need to be monitored for adverse effects such as orthostatic hypotension, somnolence, compulsive behaviors, and other dopaminergic side effects[3].

Sources

1. DelveInsight: Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034)[1].
2. PubMed: Economic evaluation of ropinirole prolonged release for treatment of Parkinson's disease[2].
3. NCBI Bookshelf: Ropinirole - StatPearls[3].
4. 360iResearch: Ropinirole Hydrochloride Tablets Market Size 2025-2030[4].
5. FDA: REQUIP® - Label[5].