MIRAPEX Drug Patent Profile

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

Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mirapex

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

Summary for MIRAPEX

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	32
Patent Applications:	4,448
Drug Prices:	Drug price information for MIRAPEX
What excipients (inactive ingredients) are in MIRAPEX?	MIRAPEX excipients list
DailyMed Link:	MIRAPEX at DailyMed

See drug prices for MIRAPEX

See drug sales revenues for MIRAPEX

Recent Clinical Trials for MIRAPEX

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

Sponsor	Phase
Massachusetts General Hospital	Phase 2/Phase 3
University of New Mexico	Early Phase 1
University of New Mexico Clinical and Translational Science Center	Early Phase 1

See all MIRAPEX clinical trials

Paragraph IV (Patent) Challenges for MIRAPEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-001	Jul 1, 1997		DISCN	Yes	No
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011		DISCN	Yes	No	8,679,533		Y
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997		DISCN	Yes	No
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007		DISCN	Yes	No

Expired US Patents for MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997	6,194,445
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997	4,886,812
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-002	Jul 1, 1997	6,001,861
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-004	Jul 1, 1997	4,886,812

International Patents for MIRAPEX

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

Country	Patent Number	Title	Estimated Expiration
Poland	334498
South Africa	9800420
New Zealand	510007	Use of pramipexole in the treatment of restless legs syndrome
Canada	1263653	TETRAHYDRO-BENZOTHIAZOLES, LEUR PREPARATION, ET LEUR EMPLOI A TITRE D'INTERMEDIAIRES OU DE PRODUITS PHARMACEUTIQUES (TETRAHYDRO-BENZTHIAZOLES, THE PREPARATION THEREOF AND THEIR USE AS INTERMEDIATE PRODUCTS OR AS PHARMACEUTICALS)

Supplementary Protection Certificates for MIRAPEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	C980002	Netherlands		PRODUCT NAME: PRAMIPEXOL, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER PRAMIPEXOL-DIHYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/97/050/001 - EU/1/97/050/010 19971014
0186087	98C0013	Belgium		PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
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

Market Dynamics and Financial Trajectory for MIRAPEX (Pramipexole)

Last updated: October 2, 2025

Introduction

MIRAPEX (pramipexole), a dopamine agonist primarily indicated for Parkinson’s disease and Restless Legs Syndrome (RLS), has established itself within the neurology pharmaceutical landscape. Since its approval by the FDA in 1997, MIRAPEX has experienced significant shifts influenced by market factors, competitive landscapes, regulatory changes, and evolving clinical guidelines. This report explores the intricate market dynamics shaping MIRAPEX's trajectory and forecasts its financial outlook amid current industry trends.

Market Landscape and Epidemiological Drivers

The global prevalence of Parkinson’s disease (PD) and RLS underpins MIRAPEX’s demand. According to the Parkinson’s Foundation, approximately 1 million Americans live with PD, with global estimates surpassing 6 million [1]. The aging population is a primary catalyst, as prevalence escalates with age. Projection models indicate a compound annual growth rate (CAGR) of 4-6% in PD cases over the next decade, directly impacting MIRAPEX’s market size.

Similarly, RLS affects an estimated 7-10% of the adult population worldwide, with significant health and quality-of-life implications [2]. The expansion of awareness and diagnostic rates further bolsters market size. The increasing adoption of MIRAPEX for both indications sustains steady demand, though saturation and patent expiration events influence revenue streams.

Competitive Dynamics and Product Lifecycle

Patent Status and Generics

MIRAPEX’s patent protection expired in the early 2010s, precipitating the entry of generic formulations into the market. Generic availability has exerted downward pressure on the drug’s pricing and reimbursement levels. The primary patent expiry in the U.S. occurred circa 2014, leading to a substantial erosion in branded sales.

Alternative Therapeutics

The competitive landscape has expanded with the approval and increased utilization of other dopamine agonists such as ropinirole and rotigotine, as well as classes like MAO-B inhibitors and levodopa.

Notably, newer agents often offer improved side-effect profiles or novel administration routes (patches, extended-release formulations). For RLS, gabapentinoids like gabapentin and pregabalin serve as alternatives, further fragmenting the market share.

Clinical Practice Trends

Evolving guidelines favor early use of levodopa in PD, with dopamine agonists like MIRAPEX reserved for early or maintenance therapy. The advent of deep brain stimulation and gene therapy options are also reshaping treatment paradigms but currently play a limited role in MIRAPEX’s sales.

Regulatory and Reimbursement Factors

Regulatory Changes

Ongoing post-marketing surveillance highlighted potential concerns regarding impulse control disorders and sleep attacks, associated with dopamine agonists. These adverse effects prompted updates to prescribing information and influence clinician preferences.

Reimbursement Policies

Health insurance coverage and formulary placements significantly affect MIRAPEX’s market penetration. Generic versions have generally achieved broad coverage, easing access but intensifying price competition.

Market Challenges and Opportunities

Adherence and Side Effect Profile

MIRAPEX’s side-effect profile, including nausea, hallucinations, and impulse control issues, impacts adherence, especially among elderly populations. Improving management of these adverse effects could expand its viable patient base.

Emerging Therapies and Precision Medicine

Advances in personalized medicine, including biomarkers for treatment response, may refine indications for MIRAPEX use, either expanding or contracting its applicability.

Patent and Market Exclusivity

The expiration timeline of exclusivity rights dictates future revenue streams. Strategies such as formulation enhancements or combination therapies could mitigate revenue declines.

Market Expansion in Emerging Economies

Growing healthcare infrastructure and disease awareness in Asia, Latin America, and Africa present opportunities for increased MIRAPEX utilization. However, price sensitivity and regulatory hurdles pose intrinsic challenges.

Financial Trajectory Analysis

Historical Revenue Trends

Since patent expiry, MIRAPEX’s global sales have declined sharply. The U.S. market, once accounting for a substantial share of revenue, saw branded sales diminish from approximately $1.2 billion in 2012 to under $300 million in 2021, primarily due to generics competition [3]. International markets mirror similar trends, although the pace varies according to regional patent laws and healthcare practices.

Current Market Performance

The current revenue forecast for MIRAPEX indicates a plateauing or slight decline as generics dominate, with some residual sales stemming from branded prescriptions for specific patient subsets. The total global market for dopamine agonists is projected to decline marginally, with a CAGR of -1% to -2% over the next five years, largely driven by commoditization and competition.

Future Outlook and Strategic Positioning

Pharmaceutical companies increasingly pivot toward lifecycle management, pursuing label expansions and new formulations to sustain revenue. For MIRAPEX, potential avenues include:

• Extended-release formulations to improve adherence.

• Combination therapies for polypharmacy reductance.

• New indications or refined dosing regimens validated through clinical trials.

However, the major revenue driver remains the existing use for PD and RLS in established markets.

External Market Influences

Regulatory Environment

Stringent regulatory oversight, particularly concerning adverse effects, influences prescribing patterns. Recent classification of impulse control disorders as serious side effects has limited the utilization in certain patient populations.

Market Entry Barriers and Patent Strategies

Biotech industries exploring biosimilars and next-generation dopamine agonists face substantial barriers including regulatory approval timelines, patent strategies, and market inertia.

Healthcare Policy and Reimbursement

Reimbursement trends favor cost-effective therapies, emphasizing generics, which directly impacts MIRAPEX’s profitability. Hence, price pressure is anticipated to intensify.

Conclusion: Key Takeaways

• Market Size & Demand Drivers: The sizable PD and RLS populations guarantee ongoing demand but are tempered by competition and clinical practice shifts.

• Patent Expiry & Competition: The expiration of MIRAPEX’s patent has precipitated a branded-to-generic transition, significantly impacting revenue.

• Therapeutic Alternatives & Clinical Guidelines: Alternatives and evolving treatment paradigms influence the drug's positioning, potentially limiting its growth.

• Regulatory & Safety Concerns: Adverse effect profiles and safety communications impact prescribing behaviors, affecting revenue stability.

• Financial Outlook: Anticipated revenue decline driven by generics, with strategic adjustments such as formulation innovations necessary for sustaining profitability.

• Emerging Opportunities: Market expansion in developing regions and pipeline innovations offer future growth potential, contingent on R&D investments and regulatory navigation.

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FAQs

1. What are the primary indications for MIRAPEX, and how do they influence its market size?
MIRAPEX is approved for Parkinson’s disease and Restless Legs Syndrome. The high prevalence of these neurological conditions, especially among aging populations, sustains steady demand. However, market size growth is restrained by alternatives and evolving treatment practices.

2. How has patent expiration affected MIRAPEX’s market revenue?
Patent expiration in the early 2010s led to widespread generic entry, causing significant revenue erosion of branded sales from over $1 billion annually to a fraction thereof, renowned for intensifying price competition.

3. What are the current challenges limiting MIRAPEX’s growth?
Key challenges include availability of cheaper generics, side-effect concerns such as impulse control disorders, competition from newer dopamine agonists and alternative therapies, and regulatory considerations impacting prescribing patterns.

4. What strategic moves can pharmaceutical companies undertake to sustain MIRAPEX’s profitability?
Potential strategies include developing new formulations (e.g., extended-release), exploring new indications, engaging in lifecycle management, and expanding into emerging markets with tailored pricing strategies.

5. What is the forecast for MIRAPEX’s financial performance over the next five years?
Given patent expiration and intense generic competition, revenues are expected to decline modestly. Companies focusing on innovation and market expansion could mitigate losses, but overall, the trend indicates a gradual decrease unless new opportunities are realized.

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References

[1] Parkinson’s Foundation. “Parkinson’s Disease Facts & Figures.” 2022.
[2] Allen RP, et al. “Restless legs syndrome epidemiology, clinical features, and diagnosis.” Sleep Medicine Reviews, 2014.
[3] IQVIA. “Pharmaceutical Market Data and Insights,” 2022.