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-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 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:	98
Clinical Trials:	32
Patent Applications:	2,000
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 Clinical and Translational Science Center	Early Phase 1
University of New Mexico	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	8,679,533		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011		DISCN	Yes	No	8,679,533		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010		DISCN	Yes	No	7,695,734		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011		DISCN	Yes	No	7,695,734		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011		DISCN	Yes	No	7,695,734		Y
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010		DISCN	Yes	No	7,695,734		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	022421-003	Feb 19, 2010	4,886,812
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010	4,886,812
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010	4,886,812
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-004	Feb 19, 2010	4,886,812
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010	4,886,812

International Patents for MIRAPEX ER

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

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP055569	FORMA DE DOSIFICACIÓN DE PRAMIPEXOL EN UNA DOSIS ÚNICA DIARIA
Mexico	2007001706	FORMULACION DE COMPRIMIDOS DE LIBERACION EXTENDIDA QUE CONTIENE PRAMIPEXOL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, METODO PARA SU FABRICACION Y SU USO. (EXTENDED RELEASE TABLET FORMULATION CONTAINING PRAMIPEXOLE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR MANUFACTURING THE SAME AND USE THEREOF.)
Serbia	52764	DOZIRANI OBLIK PRAMIPEKSOLA ZA UPOTREBU JEDANPUT DNEVNO (PRAMIPEXOLE ONCE-DAILY DOSAGE FORM)
Australia	2003261265	SUSTAINED-RELEASE TABLET COMPOSITION COMPRISING A DOPAMINE RECEPTOR AGONIST
World Intellectual Property Organization (WIPO)	2004010998
Slovenia	1536792

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

MIRAPEX ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MIRAPEX ER

Introduction to MIRAPEX ER

MIRAPEX ER, developed by Boehringer Ingelheim, is a once-daily, extended-release formulation of pramipexole dihydrochloride, approved for the treatment of both early and advanced Parkinson's disease. This medication has been a significant player in the Parkinson's disease market, and its impact can be understood through several key aspects.

Regulatory Approval and Clinical Trials

MIRAPEX ER received FDA approval in 2010 for both early and advanced Parkinson's disease, following a comprehensive clinical trial program. The approval was based on efficacy data from a randomized, double-blind, placebo-controlled study involving 517 patients with advanced Parkinson's disease. The trial demonstrated the superiority of MIRAPEX ER over placebo in reducing symptoms and daily off-time, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS)[5].

Market Impact

Competitive Landscape

MIRAPEX ER entered a market dominated by other Parkinson's disease treatments, but its once-daily dosing and extended-release formulation provided a unique selling point. The drug competes with other therapies such as immediate-release pramipexole, levodopa/carbidopa combinations, and newer treatments like SPN-830 and tavapadon. Despite this competition, MIRAPEX ER has maintained a significant market share due to its efficacy and patient compliance benefits[5].

Revenue and Market Size

The Parkinson's disease market, which includes MIRAPEX ER, was valued at USD 3.2 billion in 2023. The market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by advancements in diagnostic techniques, increased awareness, and a robust emerging pipeline of treatments[1].

Financial Performance

Sales and Revenue

While specific sales figures for MIRAPEX ER are not provided in the latest reports, the overall performance of Parkinson's disease treatments indicates a strong financial trajectory. For instance, the market share of combination therapies and other treatments, which include MIRAPEX ER, was significant, with a revenue of USD 2.2 billion in 2023[1].

Cost and Pricing

The financial success of MIRAPEX ER is also influenced by its pricing strategy. However, the market faces challenges such as unaffordable pricing and market access issues, which can impact revenue. Despite these challenges, MIRAPEX ER's established presence and clinical benefits help maintain its market position[1].

Challenges and Opportunities

Side Effects and Patient Compliance

MIRAPEX ER, like other Parkinson's disease treatments, is associated with side effects such as dyskinesia, nausea, constipation, hallucinations, headache, and anorexia. These side effects can impact patient compliance and overall market performance. However, the once-daily dosing of MIRAPEX ER has been shown to improve patient adherence compared to multiple daily doses of immediate-release formulations[5].

Emerging Therapies and Market Competition

The Parkinson's disease market is dynamic, with several emerging therapies expected to enter the market during the forecast period. Treatments like SPN-830, tavapadon, and P2B001 are anticipated to change market dynamics. However, MIRAPEX ER's established track record and FDA approval for both early and advanced Parkinson's disease positions it to remain a viable option despite increasing competition[1].

Economic Burden and Quality of Life

Parkinson's disease treatment poses a significant economic burden on patients and healthcare systems. MIRAPEX ER, while effective, contributes to this burden. However, its benefits in improving symptom relief and reducing off-time can enhance patients' quality of life, making it a valuable treatment option despite the economic challenges[5].

Key Takeaways

• Regulatory Approval: MIRAPEX ER is FDA-approved for both early and advanced Parkinson's disease, supported by robust clinical trial data.
• Market Impact: The drug has a significant market share within the Parkinson's disease treatment landscape.
• Financial Performance: Part of a growing market valued at USD 3.2 billion in 2023, with expected growth at a CAGR of 5.8% from 2020 to 2034.
• Challenges and Opportunities: Faces challenges from side effects and emerging therapies but benefits from once-daily dosing and established clinical efficacy.
• Economic Burden: Contributes to the economic burden of Parkinson's disease treatment but improves patients' quality of life.

FAQs

1. What is MIRAPEX ER, and how is it used in treating Parkinson's disease?

MIRAPEX ER is a once-daily, extended-release formulation of pramipexole dihydrochloride, used to treat both early and advanced Parkinson's disease by alleviating symptoms such as tremors, rigidity, and bradykinesia.

2. What were the key findings of the clinical trials for MIRAPEX ER?

Clinical trials demonstrated that MIRAPEX ER provided superior symptom relief and reduced daily off-time compared to placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS)[5].

3. How does MIRAPEX ER compare to other Parkinson's disease treatments?

MIRAPEX ER competes with other treatments like immediate-release pramipexole and levodopa/carbidopa combinations but offers the advantage of once-daily dosing, improving patient compliance.

4. What are the common side effects associated with MIRAPEX ER?

Common side effects include dyskinesia, nausea, constipation, hallucinations, headache, and anorexia, particularly in patients concomitantly treated with levodopa[5].

5. How does the economic burden of MIRAPEX ER impact patients and healthcare systems?

While MIRAPEX ER contributes to the economic burden of Parkinson's disease treatment, its benefits in improving symptom relief and quality of life make it a valuable treatment option despite the costs.

Cited Sources

1. GlobeNewswire: "Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034) | DelveInsight"[1]
2. Supernus Pharmaceuticals: "Dear Supernus Stockholder, 2021 was another outstanding year for..."[2]
3. FDA: "MEDICAL REVIEW(S) - accessdata.fda.gov"[3]
4. FDA: "SUMMARY REVIEW - accessdata.fda.gov"[4]
5. PR Newswire: "Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease"[5]