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TIBSOVO Drug Profile
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» See Plans and PricingWhich patents cover Tibsovo, and when can generic versions of Tibsovo launch?
Tibsovo is a drug marketed by Agios Pharms Inc and is included in one NDA. There are five patents protecting this drug.
This drug has eighty-six patent family members in thirty-four countries.
The generic ingredient in TIBSOVO is ivosidenib. Additional details are available on the ivosidenib profile page.
US ANDA Litigation and Generic Entry Outlook for Tibsovo
Tibsovo will be eligible for patent challenges on July 20, 2022. 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 March 13, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TIBSOVO
| International Patents: | 86 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 4 |
| Patent Applications: | 9 |
| Drug Prices: | Drug price information for TIBSOVO |
| DailyMed Link: | TIBSOVO at DailyMed |
Generic Entry Opportunity Date for TIBSOVO
Generic Entry Date for TIBSOVO*:
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 TIBSOVO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Northwestern University | Phase 1 |
| Agios Pharmaceuticals | Phase 1 |
US Patents and Regulatory Information for TIBSOVO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 TIBSOVO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2755394 | Start Trial |
| Japan | 2019031562 | Start Trial |
| Japan | 2017508805 | Start Trial |
| Australia | 2017265100 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010105243 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
