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Eluxadoline - Generic Drug Details
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 thirty-eight patent family members in thirty-eight countries.
There are two drug master file entries for eluxadoline. One supplier is listed for this compound.
Summary for eluxadoline
| International Patents: | 138 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 23 |
| Clinical Trials: | 4 |
| Patent Applications: | 32 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eluxadoline |
| DailyMed Link: | eluxadoline at DailyMed |
Recent Clinical Trials for eluxadoline
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 2 |
| Allergan | Phase 2 |
| Allergan | Phase 4 |
Recent Litigation for eluxadoline
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Lee | 2015-01-14 |
| Novartis AG v. Lee | 2013-01-14 |
| Allergan USA, Inc. v. Aurobindo Pharma Ltd. |
Pharmacology for eluxadoline
| Drug Class | mu-Opioid Receptor Agonist |
| Mechanism of Action | Opioid mu-Receptor Agonists |
Synonyms for eluxadoline
| 45TPJ4MBQ1 |
| 5-(((S)-2-AMINO-3-(4-CARBAMOYL-2,6-DIMETHYLPHENYL)-N-((S)-1-(4-PHENYL-1H-IMIDAZOL-2-YL)ETHYL)PROPANAMIDO)METHYL)-2-METHOXYBENZOIC ACID |
| 5-(((S)-2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)-N-((S)-1-(5-phenyl-1H-imidazol-2-yl)ethyl)propanamido)methyl)-2-methoxybenzoic acid |
| 5-({(4-carbamoyl-2,6-dimethyl-L-phenylalanyl)[(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid |
| 5-[[[(2S)-2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)propanoyl]-[(1S)-1-(4-phenyl-3H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid |
| 864821-90-9 |
| AC-30329 |
| AKOS030632800 |
| AS-35135 |
| Benzoic acid, 5-((((2S)-2-amino-3-(4-(aminocarbonyl)-2,6-dimethylphenyl)-1-oxopropyl)((1S)-1-(5-phenyl-1H-imidazol-2-yl)ethyl)amino)methyl)-2-methoxy- |
| CHEBI:85980 |
| CHEMBL2159122 |
| CS-3855 |
| D10403 |
| DB09272 |
| DEA No. 9725 |
| DTXSID70235589 |
| Eluxadoline (USAN) |
| Eluxadoline [USAN:INN] |
| EX-A1169 |
| FT-0701295 |
| GTPL7691 |
| HY-12247 |
| J3.535.064K |
| JNJ 27018966 |
| JNJ-27018966 |
| JNJ27018966 |
| NCGC00485958-01 |
| SB17335 |
| SCHEMBL12971682 |
| SCHEMBL17950908 |
| truberzi |
| UNII-45TPJ4MBQ1 |
| Viberzi |
| Viberzi (TN) |
| ZINC14210876 |
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 | 206940-001 | May 27, 2015 | RX | Yes | No | 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 | 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 |
|---|---|---|
| China | 101730685 | Start Trial |
| European Patent Office | 2968351 | Start Trial |
| Israel | 241561 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for eluxadoline
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1725537 | PA2017005,C1725537 | Lithuania | Start Trial | PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919 |
| 1725537 | LUC00007 | Luxembourg | Start Trial | PRODUCT NAME: ELUXADOLINE OU UN ENANTIOMERE, UN DIASTEREOMERE, UNRACEMATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/16/1126 20160921 |
| 1725537 | PA2017005 | Lithuania | Start Trial | PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.