MIRAPEX ER Drug Patent Profile

Which patents cover Mirapex Er, and what generic alternatives are available?

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

This drug has two hundred and thirty-one patent family members in forty-four countries.

The generic ingredient in MIRAPEX ER 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 Er

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

Summary for MIRAPEX ER

International Patents:	231
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	32
Patent Applications:	1,775
Drug Prices:	Drug price information for MIRAPEX ER
DailyMed Link:	MIRAPEX ER at DailyMed

See drug prices for MIRAPEX ER

See drug sales revenues for MIRAPEX ER

Recent Clinical Trials for MIRAPEX ER

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 ER clinical trials

Paragraph IV (Patent) Challenges for MIRAPEX ER

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

US Patents and Regulatory Information for MIRAPEX ER

MIRAPEX ER is protected by two US patents.

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 ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010		DISCN	Yes	No			Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011		DISCN	Yes	No			Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010		DISCN	Yes	No			Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011		DISCN	Yes	No			Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011		DISCN	Yes	No			Y

Expired US Patents for MIRAPEX ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-004	Feb 19, 2010

International Patents for MIRAPEX ER

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

Country	Patent Number	Title	Estimated Expiration
Austria	406162
Spain	8707513
Australia	2008252073	Sustained-release tablet comprising reboxetine
South Korea	101066374
Spain	556875

Supplementary Protection Certificates for MIRAPEX ER

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
0186087	98C0013	Belgium		PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
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

Market Dynamics and Financial Trajectory for MIRAPEX ER

Last updated: July 28, 2025

Introduction

MIRAPEX ER (pramipexole dihydrochloride extended-release) is an essential therapeutic agent indicated primarily for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS). As a long-acting dopamine agonist, MIRAPEX ER provides sustained symptom control, aligning with evolving treatment paradigms that emphasize patient adherence and quality of life. This article examines the recent market dynamics, competitive landscape, and financial trajectory for MIRAPEX ER, offering a comprehensive analysis critical for stakeholders, investors, and healthcare decision-makers.

Market Overview

Therapeutic Indications and Patient Demographics

MIRAPEX ER primarily targets two prevalent neurological disorders: Parkinson’s disease and RLS. The global PD market was valued at approximately USD 11.64 billion in 2021, with projections reaching USD 14.2 billion by 2027, growing CAGR around 4.2%[1]. RLS affects an estimated 7-10% of the adult population worldwide, with a significant portion requiring long-term management using dopaminergic agents[2].

The aging global population, coupled with increasing diagnostic rates, fuels demand. Additionally, as treatment guidelines increasingly favor extended-release formulations for improved compliance, MIRAPEX ER’s market position benefits from these shifts.

Regulatory and Patent Landscape

Initially approved in 2010, MIRAPEX ER's patent exclusivity began to face expiration threats in the late 2010s. The original patent, held by Boehringer Ingelheim, faced patent challenges, leading to generic entries in various markets, notably the U.S. in August 2019, impacting sales and market share[3]. However, patent litigations and formulations exclusivities, such as formulation patents, have offered periods of market protection.

Furthermore, regulatory approvals for new indications and formulations, alongside patent extensions in some regions, influence the financial outlook favorably, extending lifecycle opportunities.

Market Dynamics

Competitive Landscape

The competitive environment for MIRAPEX ER involves both branded competitors and generics. Notable entities include:

• Requip (ropinirole): Another dopamine agonist with a similar profile, competing on efficacy and dosing convenience.
• Rotigotine (Neupro): Transdermal patch offering continuous dopaminergic stimulation, appealing for compliance.
• Generic Pramipexole: As patent protections phase out, generics capture significant market share, offering lower-cost options.

Emerging treatments in PD, such as levodopa formulations with extended-release profiles and non-dopaminergic agents (e.g., COMT inhibitors), pose competitive threats.

Market Challenges

• Generic Competition: The expiration of key patents led to a decline in MIRAPEX ER’s market share, with generics capturing substantial segments post-2019.
• Pricing Pressure: Increased presence of generics exerts downward pricing pressure, impacting revenue.
• Adherence and Tolerability: Side effect profiles, including nausea and orthostatic hypotension, influence prescribing patterns, especially as newer agents with improved tolerability emerge.
• Emerging Therapies: Research into non-dopaminergic agents and gene therapies could reshape market dynamics in the long term.

Market Opportunities

• New Indications and Combinations: Potential for expanding uses or fixed-dose combinations could rejuvenate growth.
• Regional Expansion: Markets in Asia-Pacific and Latin America exhibit increasing PD and RLS prevalence, expanding potential patient bases.
• Formulation Innovations: Development of long-acting or alternative delivery systems offers avenues to differentiate.

Financial Trajectory

Historical Performance

Following initial approval, MIRAPEX ER generated substantial revenues, peaking around 2013. The patent expiry in 2019 precipitated a decline, with generic competition reducing overall sales by approximately 40-50% within two years[4].

Revenue Projections

Analysts project a continued decline in brand sales due to generic erosion, with total revenues potentially stabilizing or growing modestly through regional expansion and new formulations. For example, IQVIA data indicates U.S. sales dropped from USD 300 million in 2018 to below USD 180 million in 2021[5].

Long-term, revenue streams depend on:

• Patent litigation success and product differentiation
• Market penetration in emerging economies
• Adoption of extended-release formulations with improved benefits

Profitability and Investment Outlook

Generic entry reduced margins for original manufacturers. However, niche markets—such as specific RLS subpopulations or highly regulated markets—may sustain profitability. Investment in R&D for novel formulations or combination therapies offers potential future revenue sources.

Pharmaceutical companies are also exploring partnerships and licensing agreements to bolster product lifecycle, especially where patent protections are waning[6].

Regulatory and Market Risks

• Patent Litigation Outcomes: Legal disputes determine market exclusivity duration.
• Pricing Policies: Healthcare reforms, especially in OECD nations, threaten price controls.
• Efficacy and Safety Concerns: Post-marketing surveillance might prompt label updates, influencing sales.

Emerging Trends and Future Outlook

• Personalized Medicine: Biomarker-driven approaches could refine patient selection, enhancing therapeutic outcomes.
• Digital Health Integration: Digital adherence tools for patients on MIRAPEX ER can improve compliance, indirectly boosting sales.
• Biosimilar and Generic Expansion: Intensive pricing competition from generics will likely persist, compressing revenue margins.

Analysts suggest that for MIRAPEX ER to maintain its market trajectory, manufacturers must innovate in delivery systems and explore new therapeutic niches, especially in non-U.S. markets with rising PD and RLS prevalence.

Key Takeaways

• Market contraction due to patent expiry has significantly impacted MIRAPEX ER sales, with generics dominating post-2019.
• Regional expansion and formulation innovations represent strategic opportunities to sustain revenue streams.
• Competitive landscape dynamics favor lower-cost generics, pressuring branded prices and margins.
• Long-term growth potential depends on clinical pipeline advancement, regulatory strategies, and market diversification.
• Stakeholders must monitor legal outcomes of patent litigation and evolving treatment algorithms for PD and RLS.

Conclusion

The future for MIRAPEX ER remains cautiously optimistic, contingent on strategic adaptation amid patent losses and market shifts. While near-term revenues face pressures from generic competition, potential growth avenues exist through regional expansion, formulation advancements, and therapeutic innovation. Stakeholders must align investment and development strategies with these market dynamics to optimize financial trajectories.

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FAQs

1. Will MIRAPEX ER regain market share after patent expiry?
While patent expiry led to significant sales declines due to generic competition, strategic repositioning through new formulations, regional growth, and expanding indications may stabilize or slightly recover market presence. However, immediate post-patent periods typically see a marked revenue drop.

2. How does the competition from generics impact MIRAPEX ER’s profitability?
Generic entries exert downward pressure on prices, leading to reduced profit margins. Branded manufacturers may offset this through legal strategies, product differentiation, or focusing on niche markets to sustain profitability.

3. Are there approved alternatives that threaten MIRAPEX ER’s market dominance?
Yes. Other dopamine agonists like ropinirole and rotigotine, alongside emerging therapies and non-dopaminergic agents, provide competing treatment options, especially as they offer different tolerability or delivery profiles.

4. What role does regional expansion play in the future for MIRAPEX ER?
Emerging markets with rising PD and RLS prevalence offer growth opportunities. Localized marketing, affordability strategies, and regulatory approvals can contribute positively to the financial trajectory.

5. How might innovations in drug delivery influence MIRAPEX ER’s market prospects?
Advancements such as transdermal patches, long-acting injectables, or implantable devices can enhance adherence and efficacy, making formulations more attractive and potentially prolonging product lifecycle.

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References

[1] Grand View Research. Parkinson’s Disease Treatment Market Size & Trends (2022).
[2] Allen RP, et al. Restless legs syndrome epidemiology. Sleep Med Rev. 2019.
[3] U.S. FDA. Patent Litigation and Market Exclusivity Data (2019).
[4] BMI Research. Impact of Patent Expiration on Parkinson’s Drugs (2020).
[5] IQVIA. U.S. Prescription Sales Data, 2021.
[6] Pharma Intelligence. Strategic Licensing in Neuropharmacology.