You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 20, 2024

PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Generics, Heritage Pharma Avet, Mylan, 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:	24
NDAs:	32
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	120
Patent Applications:	3,047
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
Lund University	Phase 3
Region Skane	Phase 3
University of Minho	Phase 2

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	4.5MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	3MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	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	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anchen Pharms	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202206-005	Feb 6, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharma Avet	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	091254-001	Nov 30, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	078894-002	Oct 8, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Macleods Pharms Ltd	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	202164-004	Sep 20, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms Usa Inc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	078920-002	Jul 6, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	077854-003	Oct 8, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-002	Jul 1, 1997	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-004	Jul 1, 1997	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PRAMIPEXOLE DIHYDROCHLORIDE

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200700201	КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ЕЕ ПРИМЕНЕНИЕ	⤷ Try a Trial
Ukraine	93608	композициЯ таблетки пролонгированного высвобождения, которая содержит прамипексол или его фармацевтически приемлемую соль, СПОСОБ EE ИЗГОТОВЛЕНИЯ И EE ПРИМЕНЕНИЕ;КОМПОЗИЦІЯ ТАБЛЕТКИ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ, ЯКА МІСТИТЬ ПРАМІПЕКСОЛ АБО ЙОГО ФАРМАЦЕВТИЧНО ПРИЙНЯТНУ СІЛЬ, СПОСІБ ЇЇ ВИГОТОВЛЕННЯ ТА ЇЇ ЗАСТОСУВАННЯ (composition of prolonged release tablet containing Pramipeksol or pharmaceutically acceptable salt thereof, method for making and use thereof)	⤷ Try a Trial
Norway	20070733		⤷ Try a Trial
Georgia, Republic of	P20074048	SUSTAINED-RELEASE TABLET COMPOSITION OF PRAMIPEXOLE	⤷ Try a Trial
Australia	2008252073	Sustained-release tablet comprising reboxetine	⤷ Try a Trial
Malaysia	136318	SUSTAINED-RELEASE TABLET COMPOSITION	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	SPC/GB98/017	United Kingdom	⤷ Try a Trial	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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.