PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details

What are the generic sources for pramipexole dihydrochloride and what is the scope of patent protection?

Pramipexole dihydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, 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-two NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pramipexole dihydrochloride has two hundred and thirty-one patent family members in forty-four countries.

There are twenty-two drug master file entries for pramipexole dihydrochloride. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PRAMIPEXOLE DIHYDROCHLORIDE

International Patents:	231
US Patents:	2
Tradenames:	3
Applicants:	25
NDAs:	32
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	121
Patent Applications:	3,004
Drug Prices:	Drug price trends for PRAMIPEXOLE DIHYDROCHLORIDE
What excipients (inactive ingredients) are in PRAMIPEXOLE DIHYDROCHLORIDE?	PRAMIPEXOLE DIHYDROCHLORIDE excipients list
DailyMed Link:	PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed

See drug prices for PRAMIPEXOLE DIHYDROCHLORIDE

Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

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

Sponsor	Phase
Lund University	Phase 3
Region Skane	Phase 3
Hoffmann-La Roche	Phase 1

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		4.5MG	TABLET, EXTENDED RELEASE;ORAL
		3MG	TABLET, EXTENDED RELEASE;ORAL
		1.5MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Anatomical Therapeutic Chemical (ATC) Classes for PRAMIPEXOLE DIHYDROCHLORIDE

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

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
Natco Pharma	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090764-001	Apr 9, 2010		DISCN	No	No
Zennova	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090151-001	Apr 30, 2012	AB	RX	No	No
Actavis Elizabeth	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	201963-001	Apr 21, 2016	AB	RX	No	No
Sandoz	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090190-006	Oct 8, 2010		DISCN	No	No
Heritage Pharma Avet	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	077724-002	Feb 19, 2008		DISCN	No	No

Expired US Patents for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-002	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007

International Patents for PRAMIPEXOLE DIHYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Montenegro	P52208	DOZIRANI OBLIK PRAMIPEKSOLA ZA UPOTREBU JEDANPUT DNEVNO (PRAMIPEXOLE ONCE-DAILY DOSAGE FORM)
Brazil	0312948	Pramipexole em forma de dosagem uma vez ao dia
Canada	2736965	PREPARATION DE COMPRIME A AUTORISATION DE SORTIE ELARGIE, CONTENANT DU PRAMIPEXOLE OU UN SEL DE PRAMIPEXOLE PHARMACEUTIQUEMENT ACCEPTABLE, PROCEDE DE FABRICATION ET D'UTILISATION DE CE COMPRIME (EXTENDED RELEASE TABLET FORMULATION CONTAINING PRAMIPEXOLE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR MANUFACTURING THE SAME AND USE THEREOF)
China	1671383	Sustained-release tablet comprising reboxetine
Russian Federation	2292873	ТАБЛЕТКА С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩАЯРЕБОКСЕТИН (DELAYED RELEASE PILL CONTAINING REBOXETIN)

Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	SPC/GB98/017	United Kingdom		PRODUCT NAME: PRAMIPEXOLE, OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT, IN PARTICULAR PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/97/050/001 19971014; UK EU/1/97/050/002 19971014; UK EU/1/97/050/003 19971014; UK EU/1/97/050/004 19971014; UK EU/1/97/050/005 19971014; UK EU/1/97/050/006 19971014; UK EU/1/97/050/007 19971014; UK EU/1/97/050/008 19971014; UK EU/1/97/050/009 19971014; UK EU/1/97/050/010 19971014

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