By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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TIBSOVO Drug Profile
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Which 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 six patents protecting this drug.
This drug has ninety-seven patent family members in thirty-five countries.
The generic ingredient in TIBSOVO is ivosidenib. Additional details are available on the ivosidenib profile page.
DrugPatentWatch® 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: | 97 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 7 |
| Patent Applications: | 40 |
| Drug Prices: | Drug price information for TIBSOVO |
| What excipients (inactive ingredients) are in TIBSOVO? | TIBSOVO excipients list |
| DailyMed Link: | TIBSOVO at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| City of Hope Medical Center | Phase 1 |
| M.D. Anderson Cancer Center | Phase 2 |
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 | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Agios Pharms Inc | TIBSOVO | ivosidenib | TABLET;ORAL | 211192-001 | Jul 20, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| >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 |
|---|---|---|
| Ukraine | 121211 | Try Before You Buy |
| South Korea | 20140127255 | Try Before You Buy |
| Eurasian Patent Organization | 201691845 | Try Before You Buy |
| South Korea | 102144739 | Try Before You Buy |
| Mexico | 2011009690 | Try Before You Buy |
| Hungary | E039110 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
