TRUSELTIQ Drug Patent Profile
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Which patents cover Truseltiq, and what generic alternatives are available?
Truseltiq is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and thirty-five patent family members in forty countries.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. Additional details are available on the infigratinib phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Truseltiq
Truseltiq will be eligible for patent challenges on May 28, 2025. 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 December 11, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for TRUSELTIQ
| International Patents: | 135 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 2 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for TRUSELTIQ |
| What excipients (inactive ingredients) are in TRUSELTIQ? | TRUSELTIQ excipients list |
| DailyMed Link: | TRUSELTIQ at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRUSELTIQ
*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 TRUSELTIQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Emory University | Phase 2 |
| United States Department of Defense | Phase 2 |
US Patents and Regulatory Information for TRUSELTIQ
TRUSELTIQ is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRUSELTIQ is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TRUSELTIQ
Pharmaceutical dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting TRUSELTIQ
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
FOR TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-002 | May 28, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-001 | May 28, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 TRUSELTIQ
When does loss-of-exclusivity occur for TRUSELTIQ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8716
Patent: FORMAS DE DOSIFICACIÓN FARMACÉUTICAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14362999
Patent: Pharmaceutical dosage forms
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 30055
Patent: FORMES DE DOSAGE PHARMACEUTIQUE COMPRENANT UN INHIBITEUR DE PROTEINE KINASE (PHARMACEUTICAL DOSAGE FORMS COMPRISING PROTEIN KINASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 16001436
Patent: Formas de dosificación farmacéuticas
Estimated Expiration: ⤷ Sign Up
China
Patent: 5813635
Patent: 药物剂型 (Pharmaceutical dosage forms)
Estimated Expiration: ⤷ Sign Up
Patent: 6942629
Patent: 药物剂型 (Pharmaceutical dosage form)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191691
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22063
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 79667
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 16060194
Patent: FORMAS DE DOSIFICACIÓN FARMACÉUTICAS
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6288
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 1691231
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 79667
Patent: FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 97179
Patent: FORMULES DE DOSAGE PHARMACEUTIQUE (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 23833
Patent: 藥物劑型 (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 45156
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5705
Patent: צורות מינון רוקחיות (Pharmaceutical dosage forms)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22619
Estimated Expiration: ⤷ Sign Up
Patent: 04585
Estimated Expiration: ⤷ Sign Up
Patent: 17502941
Patent: 医薬剤形
Estimated Expiration: ⤷ Sign Up
Patent: 19142927
Patent: 医薬剤形 (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 79667
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4303
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16007652
Patent: FORMAS DE DOSIFICACION FARMACEUTICAS. (PHARMACEUTICAL DOSAGE FORMS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 175
Patent: Capsule comprend 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-(6-(4-(4-ethyl-piperazin-1-yl)-phenylamino)-pyrimidin-4-yl)-1-methyl-uree, liant et desintegrant, pour le traitement des maladies proliferatives
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9865
Patent: A pharmaceutical dosage form produced from the wet granulation of 3-(2,6-dichloro-3,5- dimethoxy-phenyl)-1-{ 6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl} -1-methylurea
Estimated Expiration: ⤷ Sign Up
Patent: 0002
Patent: A pharmaceutical dosage form produced from the wet granulation of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{ 6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl} -1-methylurea
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 160851
Patent: FORMAS DE DOSIFICACION FARMACEUTICAS
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016501039
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 79667
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 79667
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 270
Patent: FARMACEUTSKI OBLICI DOZE (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202104627U
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 79667
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1603064
Patent: PHARMACEUTICAL DOSAGE FORMS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2349893
Estimated Expiration: ⤷ Sign Up
Patent: 160096093
Patent: 제약 투여 형태 (PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 45983
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 21938
Estimated Expiration: ⤷ Sign Up
Patent: 00759
Estimated Expiration: ⤷ Sign Up
Patent: 1605494
Patent: Pharmaceutical dosage forms
Estimated Expiration: ⤷ Sign Up
Patent: 2128137
Patent: Pharmaceutical dosage forms
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 16000207
Patent: PHARMACEUTICAL DOSAGE FORMS.
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TRUSELTIQ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2011071821 | ⤷ Sign Up | |
| Brazil | 112012013784 | formas cristalinas de 3-(2,6-dicloro-3,5-dimetoxi fenil)-1-{6-[4-(4-etilpiperazin-1-il) fenil amino] pirimidin-4-il}-1-metil uréia e seus sais | ⤷ Sign Up |
| Eurasian Patent Organization | 036288 | ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ (PHARMACEUTICAL DOSAGE FORMS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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