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Last Updated: February 27, 2021

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Alvimopan - Generic Drug Details

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What are the generic sources for alvimopan and what is the scope of patent protection?

Alvimopan is the generic ingredient in two branded drugs marketed by Watson Labs Teva and Cubist Pharms, and is included in two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alvimopan has twenty patent family members in fourteen countries.

There are four drug master file entries for alvimopan. Two suppliers are listed for this compound.

Recent Clinical Trials for alvimopan

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

SponsorPhase
Oregon Health and Science UniversityPhase 4
CMC Ambroise ParéPhase 3
The Cleveland ClinicPhase 4

See all alvimopan clinical trials

Pharmacology for alvimopan
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Paragraph IV (Patent) Challenges for ALVIMOPAN
Tradename Dosage Ingredient NDA Submissiondate
ENTEREG CAPSULE;ORAL alvimopan 021775 2017-06-16

US Patents and Regulatory Information for alvimopan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Watson Labs Teva ALVIMOPAN alvimopan CAPSULE;ORAL 208295-001 Dec 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008 AB RX Yes Yes   Start Trial   Start Trial   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 alvimopan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008   Start Trial   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008   Start Trial   Start Trial
Cubist Pharms ENTEREG alvimopan CAPSULE;ORAL 021775-001 May 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Baxter
Mallinckrodt
McKinsey
McKesson

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