VIBERZI Drug Patent Profile
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Which patents cover Viberzi, and when can generic versions of Viberzi launch?
Viberzi is a drug marketed by Abbvie and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-two patent family members in forty countries.
The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
DrugPatentWatch® Generic Entry Outlook for Viberzi
Viberzi was eligible for patent challenges on May 27, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 14, 2033. This may change due to patent challenges or generic licensing.
There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (eluxadoline), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for VIBERZI
| International Patents: | 152 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 2 |
| Patent Applications: | 99 |
| Drug Prices: | Drug price information for VIBERZI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIBERZI |
| What excipients (inactive ingredients) are in VIBERZI? | VIBERZI excipients list |
| DailyMed Link: | VIBERZI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIBERZI
Generic Entry Date for VIBERZI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VIBERZI
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 VIBERZI
| Drug Class | mu-Opioid Receptor Agonist |
| Mechanism of Action | Opioid mu-Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for VIBERZI
Paragraph IV (Patent) Challenges for VIBERZI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIBERZI | Tablets | eluxadoline | 75 mg and 100 mg | 206940 | 6 | 2019-05-28 |
US Patents and Regulatory Information for VIBERZI
VIBERZI is protected by twenty-one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIBERZI is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VIBERZI
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF THE FREQUENCY OF ABDOMINAL PAIN AND DIARRHEA, IN AN INFLAMMATORY BOWEL DISEASE WITH DIARRHEA (IBS-D) PATIENT, WITH ELUXADOLINE TWICE DAILY WITH FOOD
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl- -1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Opioid receptor modulator dosage formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds as opioid receptor modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)
Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
EU/EMA Drug Approvals for VIBERZI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Allergan Pharmaceuticals International Limited | Truberzi | eluxadoline | EMEA/H/C/004098 Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D). |
Withdrawn | no | no | no | 2016-09-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VIBERZI
When does loss-of-exclusivity occur for VIBERZI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 14241076
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015022753
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 06472
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5228629
Estimated Expiration: ⤷ Try a Trial
Patent: 0917159
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20892
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 68351
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1559
Estimated Expiration: ⤷ Try a Trial
Patent: 1591768
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 68351
Estimated Expiration: ⤷ Try a Trial
Patent: 56321
Estimated Expiration: ⤷ Try a Trial
Patent: 65131
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 18514
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 42748
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1561
Estimated Expiration: ⤷ Try a Trial
Patent: 8718
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 49225
Estimated Expiration: ⤷ Try a Trial
Patent: 66975
Estimated Expiration: ⤷ Try a Trial
Patent: 16516694
Estimated Expiration: ⤷ Try a Trial
Patent: 19014744
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 68351
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 68351
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 68351
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2435440
Estimated Expiration: ⤷ Try a Trial
Patent: 150140681
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 93374
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 48071
Estimated Expiration: ⤷ Try a Trial
Patent: 1444590
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1815953
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering VIBERZI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2573068 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 201591768 | ДОЗИРОВАННЫЕ ПРЕПАРАТЫ В КАЧЕСТВЕ МОДУЛЯТОРОВ ОПИОИДНОГО РЕЦЕПТОРА | ⤷ Try a Trial |
| Ukraine | 86053 | СОЕДИНЕНИЯ КАК МОДУЛЯТОРЫ ОПИОИДНЫХ РЕЦЕПТОРОВ;СПОЛУКИ ЯК МОДУЛЯТОРИ ОПІОЇДНИХ РЕЦЕПТОРІВ (COMPOUNDS AS OPIOID RECEPTOR MODULATORS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIBERZI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1725537 | LUC00007 | Luxembourg | ⤷ Try a 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 | 683 | Finland | ⤷ Try a Trial | |
| 1725537 | SPC/GB17/020 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/16/1126/001-006 20160921 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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