Infigratinib phosphate - Generic Drug Details
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What are the generic sources for infigratinib phosphate and what is the scope of patent protection?
Infigratinib phosphate
is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Infigratinib phosphate has one hundred and thirty-five patent family members in forty countries.
Summary for infigratinib phosphate
| International Patents: | 135 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 1 |
| Patent Applications: | 26 |
| DailyMed Link: | infigratinib phosphate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for infigratinib phosphate
Generic Entry Date for infigratinib phosphate*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for infigratinib phosphate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
US Patents and Regulatory Information for infigratinib phosphate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-001 | May 28, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-001 | May 28, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-002 | May 28, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for infigratinib phosphate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015087283 | ⤷ Try a Trial | |
| Russian Federation | 2572848 | КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 3-(2,6-ДИХЛОР-3,5-ДИМЕТОКСИФЕНИЛ)-1-{ 6-[4-(4-ЭТИЛПИПЕРАЗИН-1-ИЛ)-ФЕНИЛАМИНО]-ПИРИМИДИН-4-ИЛ} -1-МЕТИЛМОЧЕВИНЫ И ЕЕ ДОЛЕЙ (CRYSTALLINE FORMS OF 3-(2,6-DICHLORO-3,5-DIMETHOXYPHENYL)-1-{ 6-[4-(4-ETHYLPIPERAZIN-1-YL)-PHENYLAMINO]-PYRIMIDIN-4-YL} -1-METHYLUREA AND ITS FRACTIONS) | ⤷ Try a Trial |
| Japan | 2019142927 | 医薬剤形 (PHARMACEUTICAL DOSAGE FORMS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
