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Last Updated: December 22, 2024

PRAMIPEXOLE DIHYDROCHLORIDE Drug Patent Profile


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

Pramipexole Dihydrochloride is a drug marketed by Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc. and is included in thirty NDAs.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pramipexole Dihydrochloride

A generic version of PRAMIPEXOLE DIHYDROCHLORIDE was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.

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Drug patent expirations by year for PRAMIPEXOLE DIHYDROCHLORIDE
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Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

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

SponsorPhase
Lund UniversityPhase 3
Region SkanePhase 3
Hoffmann-La RochePhase 1

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Anatomical Therapeutic Chemical (ATC) Classes for PRAMIPEXOLE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 2.25 mg and 3.75 mg 022421 1 2011-07-26
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg 022421 1 2010-06-01
MIRAPEX Tablets pramipexole dihydrochloride 0.75 mg 020667 1 2008-07-31
MIRAPEX Tablets pramipexole dihydrochloride 0.125 mg, 0.5 mg, 1 mg and 1.5 mg 020667 1 2005-06-24
MIRAPEX Tablets pramipexole dihydrochloride 0.25 mg 020667 1 2005-05-27

US Patents and Regulatory Information for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090781-001 Oct 8, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 077854-003 Oct 8, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202353-001 Dec 4, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156-007 Jan 23, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078920-002 Jul 6, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage Pharma Avet PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091254-003 Nov 30, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 211088-005 Oct 3, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PRAMIPEXOLE DIHYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pramipexole Dihydrochloride

Introduction

Pramipexole dihydrochloride, a non-ergot dopamine agonist, is widely used for the treatment of idiopathic Parkinson's disease and Restless Legs Syndrome (RLS). This article delves into the market dynamics and financial trajectory of this medication, providing insights into its current market status, future projections, and cost-effectiveness.

Market Size and Growth

The global market for pramipexole dihydrochloride tablets has been experiencing significant growth. As of 2018, the market size was substantial, and it is projected to expand at a notable Compound Annual Growth Rate (CAGR) from 2019 to 2025[4].

Current Market Trends

The market is driven by increasing prevalence of Parkinson's disease and RLS, along with the efficacy and safety profile of pramipexole dihydrochloride. The drug's versatility in being used both as early therapy and as an adjunct to levodopa further enhances its market appeal[5].

Future Projections

Projections indicate a continued and significant expansion of the market from 2023 to 2031. This upward trend in market dynamics signals the potential for sustained growth, driven by demographic factors, such as an aging population, and advancements in healthcare infrastructure[1].

Cost Effectiveness

Economic Analysis

Studies have shown that while pramipexole dihydrochloride may have higher costs compared to baseline treatments, it is more effective in managing the symptoms of Parkinson's disease. A cost-effectiveness analysis in the US revealed that the incremental cost-effectiveness ratio for pramipexole was $8,837 per quality-adjusted life year (QALY) for early PD and $12,294 per QALY for advanced PD, which is competitive with many widely used medical treatments[3].

Healthcare Resource Utilization

The cost-effectiveness of pramipexole dihydrochloride is also influenced by its impact on healthcare resource utilization. By improving the quality of life and reducing the severity of symptoms, it can lead to lower long-term healthcare costs associated with disease management and complications[3].

Pricing and Affordability

Market Pricing

The pricing of pramipexole dihydrochloride varies based on the dosage and the manufacturer. For instance, the cost of Mirapex ER tablets ranges from approximately $9.83 to $3.42 per tablet, depending on the dosage and brand. Generic versions, such as Apo-Pramipexole and Novo-Pramipexole, are available at lower prices, starting from around $0.62 per tablet[2].

Affordability and Access

The availability of generic versions and various brand options enhances the affordability and access to this medication. This diversity in pricing helps in making the drug more accessible to a broader patient population, contributing to its market growth.

Competitive Landscape

Market Players

The market for pramipexole dihydrochloride is characterized by the presence of several key players, including pharmaceutical companies like Boehringer Ingelheim (the original manufacturer of Mirapex) and various generic manufacturers such as Sandoz, Apotex, and Novopharm. The competition among these players helps in maintaining competitive pricing and ensuring a steady supply of the medication[5].

Product Differentiation

While the active ingredient remains the same, different manufacturers may offer variations in formulation, such as extended-release tablets, which can influence patient preference and prescribing patterns. This differentiation can impact market share and financial performance of individual companies.

Regulatory Environment

Approval and Indications

Pramipexole dihydrochloride is approved for the treatment of idiopathic Parkinson's disease and moderate to severe RLS. Regulatory approvals and indications play a crucial role in shaping the market dynamics, as they influence the drug's usage and prescribing guidelines[5].

Safety and Efficacy Monitoring

Regulatory bodies closely monitor the safety and efficacy of pramipexole dihydrochloride. Any changes in regulatory requirements or safety alerts can impact the drug's market performance and financial trajectory.

Patient and Physician Preferences

Patient Compliance

Patient compliance is a significant factor in the market dynamics of pramipexole dihydrochloride. The drug's side effect profile, ease of administration, and effectiveness in symptom management influence patient adherence to the treatment regimen[5].

Physician Prescribing Patterns

Physician preferences and prescribing patterns also play a crucial role. The drug's efficacy, safety profile, and cost-effectiveness are key considerations for healthcare providers when deciding on treatment options for their patients.

Adverse Effects and Safety Profile

Common Adverse Effects

Pramipexole dihydrochloride is associated with several adverse effects, including hallucinations, orthostatic hypotension, and augmentation in RLS patients. These side effects can impact patient compliance and overall market performance[5].

Rare but Serious Adverse Effects

Rare but serious adverse effects such as connective tissue fibrotic complications, although not reported with pramipexole, are associated with ergot-derived dopaminergic agents. Monitoring these risks is essential for maintaining patient safety and market confidence.

Geriatric Considerations

Age-Related Renal Function

Given that the majority of pramipexole is cleared via renal secretion, age-related reductions in renal function can affect drug clearance in geriatric patients. This necessitates careful dosing and monitoring in older adults[5].

Increased Risk of Hallucinations

Geriatric patients are at a higher risk of hallucinations when treated with pramipexole dihydrochloride. This increased risk requires careful patient monitoring and adjustment of treatment plans as necessary.

Key Takeaways

  • Market Growth: The global market for pramipexole dihydrochloride is projected to grow significantly from 2023 to 2031.
  • Cost Effectiveness: Despite higher costs, pramipexole dihydrochloride is more effective and cost-effective compared to baseline treatments.
  • Pricing and Affordability: The availability of generic versions enhances affordability and access to the medication.
  • Regulatory Environment: Regulatory approvals and safety monitoring are crucial for market dynamics.
  • Patient and Physician Preferences: Patient compliance and physician prescribing patterns significantly influence market performance.

FAQs

What is pramipexole dihydrochloride used for?

Pramipexole dihydrochloride is used for the treatment of the signs and symptoms of idiopathic Parkinson's disease and moderate to severe Restless Legs Syndrome (RLS)[2].

How is pramipexole dihydrochloride metabolized and eliminated?

Pramipexole dihydrochloride is primarily eliminated through renal secretion, with about 90% of the dose found in the urine almost entirely as unchanged drug[2].

What are the common adverse effects of pramipexole dihydrochloride?

Common adverse effects include hallucinations, orthostatic hypotension, and augmentation in RLS patients. Geriatric patients are at a higher risk of hallucinations[5].

Is pramipexole dihydrochloride cost-effective?

Yes, despite higher costs, pramipexole dihydrochloride is more effective and cost-effective compared to baseline treatments, with incremental cost-effectiveness ratios that are competitive with many widely used medical treatments[3].

How does the regulatory environment impact the market for pramipexole dihydrochloride?

Regulatory approvals and safety monitoring are crucial for shaping the market dynamics, influencing the drug's usage and prescribing guidelines[5].

Sources

  1. Global Pramipexole Dihydrochloride Tablets Market Size, Trends ... - Market Research Intellect
  2. Pramipexole: Uses, Interactions, Mechanism of Action - DrugBank
  3. Cost effectiveness of pramipexole in Parkinson's disease in the US - PubMed
  4. Pramipexole Dihydrochloride Market Size, Share, Trend and ... - Prof Research
  5. Pramipexole Dihydrochloride Tablets - Health Canada Drug Product Database

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