You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Johnson and Johnson
Dow
Merck
McKesson

Last Updated: August 8, 2020

DrugPatentWatch Database Preview

STALEVO 150 Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

When do Stalevo 150 patents expire, and what generic alternatives are available?

Stalevo 150 is a drug marketed by Orion Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in forty-one countries.

The generic ingredient in STALEVO 150 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

US ANDA Litigation and Generic Entry Outlook for Stalevo 150

Stalevo 150 was eligible for patent challenges on October 19, 2003.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Summary for STALEVO 150
International Patents:58
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 5
Clinical Trials: 16
Formulation / Manufacturing:see details
DailyMed Link:STALEVO 150 at DailyMed
Drug patent expirations by year for STALEVO 150
Recent Clinical Trials for STALEVO 150

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Asan Medical CenterN/A
SynAgile CorporationPhase 2
IRCCS San RaffaelePhase 2

See all STALEVO 150 clinical trials

Paragraph IV (Patent) Challenges for STALEVO 150
Tradename Dosage Ingredient NDA Submissiondate
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2009-05-19
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-28
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2008-08-05
STALEVO 150 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 200 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 50 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 75 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 100 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29
STALEVO 125 TABLET;ORAL carbidopa; entacapone; levodopa 021485 2007-06-29

US Patents and Regulatory Information for STALEVO 150

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orion Pharma STALEVO 150 carbidopa; entacapone; levodopa TABLET;ORAL 021485-003 Jun 11, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start 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 STALEVO 150

Supplementary Protection Certificates for STALEVO 150

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 91071 Luxembourg   Start Trial 91071, EXPIRES: 20151101
0426468 0490007-2 Sweden   Start Trial PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468 C00426468/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0426468 CA 2004 00007 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Baxter
Express Scripts
McKinsey
McKesson

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.