Pharsight

1. Mirapex patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6194445	BOEHRINGER INGELHEIM	Use of pramipexole in the treatment of restless legs syndrome	Jan, 2018 (6 years ago)
US6001861	BOEHRINGER INGELHEIM	Use of pramipexole in the treatment of restless legs syndrome	Jan, 2018 (6 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-104)	May 13, 2014

Market Authorisation Date: 01 July, 1997

Treatment: Treatment of moderate to severe primary restless legs syndrome (rls)

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.125 mg, 0.5 mg, 1 mg and 1.5 mg	24 Jun, 2005	1	19 Feb, 2008	25 Mar, 2011	Eligible
0.25 mg	27 May, 2005	1	19 Feb, 2008	25 Mar, 2011	Eligible
0.75 mg	31 Jul, 2008	1	09 Apr, 2010	08 Oct, 2010	Extinguished Eligible

Strength	Dosage	Availability
0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued
0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued

Application	Filing Date	Opposition Party	Legal Status

EP03771959A	2014-06-16	Maiwald Patentanwalts GmbH	Opposition rejected
EP03771959A	2013-10-14	Actavis Group PTC ehf	Opposition rejected
EP05763065A	2012-08-04	Dr. May, Mark Andrew	Patent maintained as amended
EP05777774A	2011-08-03	Teva Pharmaceutical Industries LTD.	Patent maintained as amended
EP05777774A	2011-08-03	Sölch, Günter	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8679533	September, 2011	Decision	Ernest J. Lee et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7695734	BOEHRINGER INGELHEIM	Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof	Apr, 2028 (4 years from now)
US8679533	BOEHRINGER INGELHEIM	Pramipexole once-daily dosage form	Sep, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-623)	Mar 19, 2013
New Dosage Form(NDF)	Feb 19, 2013

Market Authorisation Date: 19 February, 2010

Treatment: Treatment of parkinson's disease

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg	01 Jun, 2010	1		26 Apr, 2028	Extinguished
2.25 mg and 3.75 mg	26 Jul, 2011	1	06 Feb, 2014	26 Apr, 2028	Eligible

Strength	Dosage	Availability
2.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
4.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
1.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
3.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
3MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
0.75MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
0.375MG	TABLET, EXTENDED RELEASE;ORAL	Prescription