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Details for New Drug Application (NDA): 207999
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NDA 207999 describes OCALIVA, which is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are ten patents protecting this drug. Additional details are available on the OCALIVA profile page.
The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this compound. Additional details are available on the obeticholic acid profile page.
The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this compound. Additional details are available on the obeticholic acid profile page.
Summary for 207999
| Tradename: | OCALIVA |
| Applicant: | Intercept Pharms Inc |
| Ingredient: | obeticholic acid |
| Patents: | 10 |
Generic Entry Opportunity Date for 207999
Generic Entry Date for 207999*:
Constraining patent/regulatory exclusivity:
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.
Paragraph IV (Patent) Challenges for 207999
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OCALIVA | TABLET;ORAL | obeticholic acid | 207999 | 2020-05-27 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 27, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 27, 2021 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Regulatory Exclusivity Expiration: | May 27, 2023 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
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