Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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Carbidopa; entacapone; levodopa - Generic Drug Details

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What are the generic sources for carbidopa; entacapone; levodopa and what is the scope of patent protection?

Carbidopa; entacapone; levodopa is the generic ingredient in seven branded drugs marketed by Sun Pharm, Wockhardt Ltd, and Orion Pharma, and is included in four NDAs. There are two patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; entacapone; levodopa has fifty-eight patent family members in forty-one countries.

There are eighteen drug master file entries for carbidopa; entacapone; levodopa. Five suppliers are listed for this compound.

Summary for carbidopa; entacapone; levodopa
Recent Clinical Trials for carbidopa; entacapone; levodopa

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

SponsorPhase
TFS Trial Form SupportPhase 1
LobSor Pharmaceuticals ABPhase 1
Asan Medical CenterN/A

See all carbidopa; entacapone; levodopa clinical trials

Recent Litigation for carbidopa; entacapone; levodopa

Identify potential future generic entrants

District Court Litigation
Case NameDate
Orion Corporation v. Mylan Pharmaceuticals Inc.2012-04-26
ORION CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES INC.2007-11-13
Orion Corporation v. Wockhardt USA Inc.2007-09-13

See all carbidopa; entacapone; levodopa litigation

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

US Patents and Regulatory Information for carbidopa; entacapone; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-005 Nov 20, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Orion Pharma STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485-002 Jun 11, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-003 Nov 20, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 079085-002 May 10, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-001 Nov 20, 2012 DISCN No No   Start Trial   Start Trial   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 carbidopa; entacapone; levodopa

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Mallinckrodt
Dow
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Johnson and Johnson

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 verifification 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.