Pramipexole dihydrochloride - Generic Drug Details

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What are the generic drug sources for pramipexole dihydrochloride and what is the scope of freedom to operate?

Pramipexole dihydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty-two 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-one patent family members in forty-four countries.

There are twenty-two 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:	231
US Patents:	2
Tradenames:	3
Applicants:	25
NDAs:	32
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	121
Patent Applications:	3,004
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
Lund University	Phase 3
Region Skane	Phase 3
Hoffmann-La Roche	Phase 1

See all pramipexole dihydrochloride clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	4.5MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	3MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for pramipexole dihydrochloride

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE

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
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 pramipexole dihydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	201963-004	Apr 21, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090190-001	Jul 6, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	213444-006	Feb 3, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs Inc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	091450-001	Oct 8, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zennova	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090151-003	Apr 30, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-001	Jul 1, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for pramipexole dihydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-002	Jul 1, 1997	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-004	Feb 19, 2010	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for pramipexole dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
China	101005831	Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof	⤷ Sign Up
China	1671381	Pramipexole once-daily dosage form	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004010999		⤷ Sign Up
Norway	334298		⤷ Sign Up
Hong Kong	1104973	EXTENDED RELEASE TABLET FORMULATION CONTAINING PRAMIPEXOLE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR MANUFACTURING THE SAME AND USE THEREOF	⤷ Sign Up
Brazil	0312960	Composição de comprimido de liberação sustentada de pramipexol	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for pramipexole dihydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	SPC/GB98/017	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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