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 Endo Operations, Hikma, 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. Four suppliers are listed for this compound.

Summary for ALVIMOPAN

International Patents:	1
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	31
Patent Applications:	1,154
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALVIMOPAN
What excipients (inactive ingredients) are in ALVIMOPAN?	ALVIMOPAN excipients list
DailyMed Link:	ALVIMOPAN at DailyMed

Recent Clinical Trials for ALVIMOPAN

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

Sponsor	Phase
Oregon Health and Science University	Phase 4
CMC Ambroise Paré	Phase 3
The Cleveland Clinic	Phase 4

See all ALVIMOPAN clinical trials

Pharmacology for ALVIMOPAN

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ALVIMOPAN

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ALVIMOPAN	alvimopan	CAPSULE;ORAL	217753-001	Aug 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Teva	ALVIMOPAN	alvimopan	CAPSULE;ORAL	208295-001	Dec 19, 2019	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for ALVIMOPAN

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005055953		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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