ODEVIXIBAT - Generic Drug Details
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What are the generic drug sources for odevixibat and what is the scope of freedom to operate?
Odevixibat
is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Odevixibat has one hundred and ten patent family members in forty countries.
Two suppliers are listed for this compound.
Summary for ODEVIXIBAT
| International Patents: | 110 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 4 |
| Patent Applications: | 174 |
| What excipients (inactive ingredients) are in ODEVIXIBAT? | ODEVIXIBAT excipients list |
| DailyMed Link: | ODEVIXIBAT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ODEVIXIBAT
Generic Entry Date for ODEVIXIBAT*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;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 ODEVIXIBAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Albireo | Phase 3 |
Pharmacology for ODEVIXIBAT
| Drug Class | Ileal Bile Acid Transporter Inhibitor |
| Mechanism of Action | Ileal Bile Acid Transporter Inhibitors |
US Patents and Regulatory Information for ODEVIXIBAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-001 | Jul 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-001 | Jul 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-002 | Jul 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | RX | Yes | 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 ODEVIXIBAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-002 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-001 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ipsen | BYLVAY | odevixibat | CAPSULE, PELLETS;ORAL | 215498-003 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ipsen | BYLVAY | odevixibat | CAPSULE;ORAL | 215498-004 | Jul 20, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ODEVIXIBAT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Albireo | Bylvay | odevixibat | EMEA/H/C/004691 Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1). |
Authorised | no | no | yes | 2021-07-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ODEVIXIBAT
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2020013774 | MODIFICACIONES DE CRISTALES DE ODEVIXIBAT. (CRYSTAL MODIFICATIONS OF ODEVIXIBAT.) | ⤷ Try a Trial |
| Lithuania | 3400944 | ⤷ Try a Trial | |
| European Patent Office | 3810581 | MODIFICATIONS CRISTALLINES D'ODÉVIXIBAT (CRYSTAL MODIFICATIONS OF ODEVIXIBAT) | ⤷ Try a Trial |
| European Patent Office | 3400944 | INHIBITEURS IBAT POUR LE TRAITEMENT DE MALADIES DU FOIE (IBAT INHIBITORS FOR THE TREATMENT OF LIVER DISEASES) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ODEVIXIBAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3400944 | SPC/GB21/078 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING ODEVIXIBAT SESQUIHYDRATE; REGISTERED: UK EU/1/21/1566(NI) 20210719; UK PLGB 36216/0001 20210719; UK PLGB 36216/0002 20210719 |
| 3400944 | 2021C/554 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/21/1566 20210719 |
| 3400944 | CA 2022 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719 |
| 3400944 | CR 2022 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ODEVIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1566 20210719 |
| >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.
ISSN: 2162-2639
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