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Eluxadoline - Generic Drug Details
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What are the generic sources for eluxadoline and what is the scope of patent protection?
Eluxadoline
is the generic ingredient in one branded drug marketed by Allergan Holdings and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eluxadoline has one hundred and forty-nine patent family members in forty countries.
There are two drug master file entries for eluxadoline. One supplier is listed for this compound.
Summary for eluxadoline
International Patents: | 149 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 26 |
Clinical Trials: | 5 |
Patent Applications: | 111 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eluxadoline |
What excipients (inactive ingredients) are in eluxadoline? | eluxadoline excipients list |
DailyMed Link: | eluxadoline at DailyMed |
Recent Clinical Trials for eluxadoline
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Temple University | Phase 2/Phase 3 |
University of North Carolina, Chapel Hill | Phase 2 |
Allergan | Phase 2 |
Pharmacology for eluxadoline
Drug Class | mu-Opioid Receptor Agonist |
Mechanism of Action | Opioid mu-Receptor Agonists |
Paragraph IV (Patent) Challenges for ELUXADOLINE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
VIBERZI | TABLET;ORAL | eluxadoline | 206940 | 2019-05-28 |
US Patents and Regulatory Information for eluxadoline
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Allergan Holdings | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | 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 |
International Patents for eluxadoline
Country | Patent Number | Estimated Expiration |
---|---|---|
Montenegro | 02221 | Start Trial |
Portugal | 2653465 | Start Trial |
China | 105228629 | Start Trial |
Denmark | 2653465 | Start Trial |
Canada | 2695126 | Start Trial |
Portugal | 1725537 | Start Trial |
Ukraine | 104713 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for eluxadoline
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1725537 | 1790007-7 | Sweden | Start Trial | PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REG. NO/DATE: EU/1/16/1126 20160921 |
1725537 | 2017/007 | Ireland | Start Trial | PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919 |
1725537 | 300865 | Netherlands | Start Trial | PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER,DIASTEREOMEER, RACEMAAT OF ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1126 20160921 |
1725537 | 132017000028006 | Italy | Start Trial | PRODUCT NAME: ELUXADOLINE O UN ENANTIOMERO, DIASTEREOMERO, RACEMATO FARMACEUTICAMENTE ACCETTABILE O SALI DELLO STESSO(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921 |
1725537 | 17C1006 | France | Start Trial | PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/16/1126 20160921 |
1725537 | CR 2017 00008 | Denmark | Start Trial | PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921 |
1725537 | 122017000009 | Germany | Start Trial | PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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