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-four 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:	279
Clinical Trials:	32
Patent Applications:	29
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
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010		DISCN	Yes	No	8,679,533		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010		DISCN	Yes	No	8,679,533		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010		DISCN	Yes	No	8,679,533		Y

Expired US Patents for MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	4,886,812
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998	4,886,812
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997	4,886,812
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	4,843,086
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	6,001,861
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007	6,001,861
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-002	Jul 1, 1997	4,843,086

International Patents for MIRAPEX

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0001913
European Patent Office	0186087	TETRAHYDRO-BENZOTHIAZOLES, THEIR PRODUCTION AND THEIR USE AS INTERMEDIATES OR DRUGS
Poland	190898
Slovenia	0989850
China	1243439
Bulgaria	62023
New Zealand	510007	Use of pramipexole in the treatment of restless legs syndrome

Supplementary Protection Certificates for MIRAPEX

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

MIRAPEX Market Analysis and Financial Projection Experimental

Parkinson's Disease Treatment Market: Focus on Mirapex (Pramipexole)

Market Overview of Parkinson's Disease Treatment

The global Parkinson's disease treatment market has been experiencing significant growth, driven by several key factors. As of 2021, the market was valued at USD 4.28 billion and is projected to reach USD 11.98 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.1% from 2022 to 2030[1][3][5].

Drug Class Segment: Dopamine Agonists

Mirapex (Pramipexole) in the Market

Mirapex, also known as pramipexole, is a dopamine agonist that plays a crucial role in the treatment of Parkinson's disease. It is one of the four FDA-approved dopamine agonists, along with Requip (ropinirole), Apokyn (apomorphine), and Neupro (rotigotine)[1].

Market Share and Growth

The dopamine agonists segment, which includes Mirapex, is a significant part of the Parkinson's disease treatment market. These drugs are widely prescribed due to their effectiveness in managing motor symptoms associated with Parkinson's disease. The ease of availability of these medications, including both long-acting and regular formulations of pramipexole, further boosts their market share[1].

Financial Trajectory

The financial trajectory of Mirapex is closely tied to the overall growth of the dopamine agonists segment. With the global Parkinson's disease treatment market expected to expand significantly, the demand for dopamine agonists like Mirapex is anticipated to increase. The segment's growth is driven by the rising disease burden, increasing awareness, and advancements in research and development[1][3].

Distribution Channels

Retail and Online Pharmacies

Mirapex is widely available through various distribution channels, including retail pharmacies such as Walgreens and Walmart Stores. The trend of online shopping for medications is also on the rise, offering convenience, flexibility, and discounts, which is expected to drive the growth of the online pharmacy segment. This ease of access contributes to the financial success of Mirapex and other Parkinson's disease treatments[1].

Regional Outlook

North America Dominance

North America, particularly the U.S., dominates the global Parkinson's disease treatment market, accounting for a significant revenue share. This dominance is attributed to the presence of leading pharmaceutical companies, advanced healthcare infrastructure, and extensive research activities in the region. Mirapex, being a widely prescribed medication, benefits from this regional dominance[1][3].

Key Drivers of Market Growth

Strong Product Pipeline

The approval of novel medicines and the presence of a strong product pipeline are key drivers of the market growth. For instance, pipeline candidates like LY03003 and the recent approvals of new treatments contribute to the segment's expansion[1].

Rising Disease Burden

The increasing prevalence of Parkinson's disease, especially in developed countries, drives the demand for effective treatments like Mirapex. This rising disease burden is a significant factor in the market's financial trajectory[1][3].

Government Initiatives and Healthcare Policies

Government initiatives and healthcare policies aimed at improving access to treatments and promoting research also contribute to the market's growth. These initiatives support the development and approval of new therapies, including dopamine agonists like Mirapex[3].

Competitive Landscape

Key Players

The Parkinson's disease treatment market is competitive, with several key players including Novartis AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., GlaxoSmithKline plc., AbbVie, Inc., and H. Lundbeck A/S. Boehringer Ingelheim, the manufacturer of Mirapex, is a significant player in this market, benefiting from the drug's popularity and the overall market growth[1].

Future Outlook

Growing Demand for Online Pharmacies

The trend of online shopping for medications is expected to continue, with the online pharmacy segment predicted to grow at a significant CAGR during the forecast period. This shift towards online pharmacies will likely increase the accessibility and sales of Mirapex and other Parkinson's disease treatments[1][3].

Advancements in Research and Development

Advancements in research and development, including the introduction of novel formulations and delivery methods, will continue to drive the market growth. For example, the development of new dopamine agonists and combination therapies will further enhance the treatment options available for Parkinson's disease patients[1][3].

Key Takeaways

• Market Growth: The global Parkinson's disease treatment market is expected to grow from USD 4.61 billion in 2022 to USD 11.98 billion by 2030, with a CAGR of 12.1%.
• Dopamine Agonists: Mirapex (pramipexole) is a key player in the dopamine agonists segment, which is a significant part of the market.
• Distribution Channels: The drug is available through retail and online pharmacies, with the online segment expected to grow significantly.
• Regional Dominance: North America, particularly the U.S., dominates the market due to advanced healthcare infrastructure and extensive research activities.
• Key Drivers: Strong product pipeline, rising disease burden, and government initiatives are key drivers of market growth.

FAQs

What is the current market size of the Parkinson's disease treatment market?

The global Parkinson's disease treatment market was valued at USD 4.28 billion in 2021 and is expected to reach USD 11.98 billion by 2030[1][3][5].

Which segment dominates the Parkinson's disease treatment market by drug class?

The carbidopa-levodopa segment accounted for the highest revenue share in 2021, but the dopamine agonists segment, including Mirapex, is also significant and growing[1][3].

What are the key distribution channels for Parkinson's disease treatments like Mirapex?

The key distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, with the online segment expected to grow rapidly[1][3].

Which region dominates the global Parkinson's disease treatment market?

North America, particularly the U.S., dominates the global market due to its advanced healthcare infrastructure and extensive research activities[1][3].

What are the major factors driving the growth of the Parkinson's disease treatment market?

The major factors include a strong product pipeline, rising disease burden, government initiatives, and advancements in research and development[1][3].

Sources

1. Grand View Research: Parkinson's Disease Treatment Market Size Report, 2030.
2. Fierce Biotech: Through 2020, Growth in the Parkinson's Disease Drug Market Will Be Constrained by Generic.
3. GlobeNewswire: $11.66 Billion Parkinson's Disease Market Forecast, 2034.
4. CoherentMI: Restless Legs Syndrome Treatment Market Size.
5. SkyQuest: Parkinson's Disease Drug Market Size, Share, Trends & Forecast.