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PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details

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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 Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharma, Mylan, Nostrum Labs Inc, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty 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-two patent family members in forty-four countries.

There are twenty-five 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:	232
US Patents:	2
Tradenames:	3
Applicants:	22
NDAs:	30
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	115
Patent Applications:	2,334
Formulation / Manufacturing:	see details
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
Massachusetts General Hospital	Phase 2/Phase 3
First Affiliated Hospital of Zhejiang University	N/A
Hongguan biological pharmaceutical co.	N/A

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

Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MIRAPEX ER	TABLET, EXTENDED RELEASE;ORAL	pramipexole dihydrochloride	022421	2011-07-26
MIRAPEX ER	TABLET, EXTENDED RELEASE;ORAL	pramipexole dihydrochloride	022421	2010-06-01
MIRAPEX	TABLET;ORAL	pramipexole dihydrochloride	020667	2008-07-31
MIRAPEX	TABLET;ORAL	pramipexole dihydrochloride	020667	2005-06-24
MIRAPEX	TABLET;ORAL	pramipexole dihydrochloride	020667	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
Sandoz	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090190-006	Oct 8, 2010		DISCN	No	No
Anchen Pharms	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202206-003	Feb 6, 2014	AB	RX	No	No
Alembic Pharms Ltd	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	204518-005	Jan 2, 2019		DISCN	No	No
Glenmark Generics	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090781-004	Oct 8, 2010	AB	RX	No	No
Sun Pharm Inds Inc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	091683-001	Mar 27, 2013		DISCN	No	No
Zydus Pharms	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202891-003	Dec 12, 2017	AB	RX	No	No
Heritage Pharma	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090241-005	Oct 8, 2010		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	020667-002	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998

International Patents for PRAMIPEXOLE DIHYDROCHLORIDE

Country	Patent Number	Estimated Expiration
Canada	2492424
Serbia	115104
Spain	2421787
Eurasian Patent Organization	016850
Denmark	1781260
Russian Federation	2005101639
Panama	8578301

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