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Last Updated: March 1, 2024

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 Hikma, Par Pharm, Watson Labs Teva, and Cubist Pharms, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alvimopan has one patent family member in one country.

There are four drug master file entries for alvimopan. Five 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 Strength NDA ANDAs Submitted Submissiondate
ENTEREG Capsules alvimopan 12 mg 021775 1 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 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma ALVIMOPAN alvimopan CAPSULE;ORAL 217753-001 Aug 31, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm ALVIMOPAN alvimopan CAPSULE;ORAL 216843-001 Jan 24, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Teva ALVIMOPAN alvimopan CAPSULE;ORAL 208295-001 Dec 19, 2019 AB RX No Yes ⤷  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 alvimopan

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

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