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INREBIC Drug Profile
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Which patents cover Inrebic, and what generic alternatives are available?
Inrebic is a drug marketed by Impact and is included in one NDA. There are four patents protecting this drug.
This drug has seventy-seven patent family members in thirty-four countries.
The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Inrebic
Inrebic will be eligible for patent challenges on August 16, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 4, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for INREBIC
| International Patents: | 77 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 81 |
| Patent Applications: | 62 |
| Drug Prices: | Drug price information for INREBIC |
| DailyMed Link: | INREBIC at DailyMed |
Generic Entry Opportunity Date for INREBIC
Generic Entry Date for INREBIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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.
US Patents and Regulatory Information for INREBIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | 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 INREBIC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E028987 | Start Trial |
| Russian Federation | 2008121807 | Start Trial |
| Russian Federation | 2597364 | Start Trial |
| Tunisia | 2013000195 | Start Trial |
| Taiwan | 200804308 | Start Trial |
| South Korea | 20180122029 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
