TABRECTA Drug Patent Profile
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Which patents cover Tabrecta, and when can generic versions of Tabrecta launch?
Tabrecta is a drug marketed by Novartis Pharm and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and seventy-five patent family members in forty-four countries.
The generic ingredient in TABRECTA is capmatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the capmatinib hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Tabrecta
Tabrecta was eligible for patent challenges on May 6, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 22, 2035. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for TABRECTA
| International Patents: | 175 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for TABRECTA |
| What excipients (inactive ingredients) are in TABRECTA? | TABRECTA excipients list |
| DailyMed Link: | TABRECTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TABRECTA
*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 TABRECTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Timothy Burns | Phase 2 |
| Novartis | Phase 2 |
Pharmacology for TABRECTA
Paragraph IV (Patent) Challenges for TABRECTA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TABRECTA | Tablets | capmatinib hydrochloride | 150 mg and 200 mg | 213591 | 1 | 2024-05-06 |
US Patents and Regulatory Information for TABRECTA
TABRECTA is protected by five US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TABRECTA 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 TABRECTA
Tablet formulation of 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,- 4]triazin-2-yl]benzamide and processes related to preparing the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,- 4]triazin-2-yl]benzamide and processes related to preparing the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION
FDA Regulatory Exclusivity protecting TABRECTA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-001 | May 6, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-001 | May 6, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-001 | May 6, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | 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 TABRECTA
When does loss-of-exclusivity occur for TABRECTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1286
Patent: FORMULACIÓN EN FORMA DE TABLETA DE UN INHIBIDOR DE C-MET
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 15293539
Patent: Tablet formulation of 2-fluoro-N-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide
Estimated Expiration: ⤷ Sign Up
Patent: 18207947
Patent: Tablet formulation of 2-fluoro-N-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)Benzamide
Estimated Expiration: ⤷ Sign Up
Patent: 20200912
Patent: Tablet formulation of 2-fluoro-N-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)Benzamide
Estimated Expiration: ⤷ Sign Up
Patent: 21202500
Patent: Tablet formulation of 2-fluoro-N-methyl-4-(7-(quinolin-6- ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)Benzamide
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017000953
Patent: formulação de comprimido de 2-flúor-n-metil-4-[7-(quinolin-6-il-metil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 54840
Patent: FORMULATION DE COMPRIME DE 2-FLUORO-N-METHYL-4-[7-(QUINOLINE -6-YLMETHYL) IMIDAZO[1,2-B] [1,2,4]TRIAZINE -2-YL]BENZAMIDE (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17000180
Patent: Formulacion en forma de tableta de 2-fluor-n-metil-4-[7-(quinolin-6-ilmetil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida.
Estimated Expiration: ⤷ Sign Up
China
Patent: 6714784
Patent: 2‑氟‑N‑甲基‑4‑[7‑(喹啉‑6‑基甲基)咪唑并[1,2‑b][1,2,4]三嗪‑2‑基]苯甲酰胺的片剂制剂 (Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide)
Estimated Expiration: ⤷ Sign Up
Patent: 5364061
Patent: C-MET抑制剂的片剂制剂 (Tablet formulations of C-MET inhibitors)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17000586
Patent: Formulación en forma de tableta de 2-fluor-n-metil-4-[7-(quinolin-6-ylmetil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 72209
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17011672
Patent: FORMULACIÓN EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 9220
Patent: СОСТАВ ТАБЛЕТКИ 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-b][1,2,4]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 1790259
Patent: СОСТАВ ТАБЛЕТОК 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА
Estimated Expiration: ⤷ Sign Up
Patent: 2191301
Patent: СОСТАВ ТАБЛЕТОК 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 72209
Patent: FORMULATION DE COMPRIMÉ DE 2-FLUORO-N-MÉTHYL-4-[7-(QUINOLINE -6-YLMÉTHYL) IMIDAZO[1,2-B][1,2,4]TRIAZINE -2-YL]BENZAMIDE (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 48376
Patent: FORMULATION DE COMPRIMÉ D'UN INHIBITEUR DE C-MET (TABLET FORMULATION OF A C-MET INHIBITOR)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1058
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 1700007
Patent: FORMULACIÓN EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2-B] [1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 53346
Estimated Expiration: ⤷ Sign Up
Patent: 200054
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0166
Patent: פורמולצית טבליה של 2-פלואורו-n-מתיל-4-[7-(קווינולינ-6-ילמתיל)אימידזו[1, 2-b][1,2,4]טריאזינ-2-יל]בנזאמיד (Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 70946
Estimated Expiration: ⤷ Sign Up
Patent: 02587
Estimated Expiration: ⤷ Sign Up
Patent: 17521469
Patent: ２−フルオロ−Ｎ−メチル−４−［７−（キノリン−６−イルメチル）イミダゾ［１，２−Ｂ］［１，２，４］トリアジン−２−イル］ベンズアミドの錠剤
Estimated Expiration: ⤷ Sign Up
Patent: 20114852
Patent: ２−フルオロ−Ｎ−メチル−４−［７−（キノリン−６−イルメチル）イミダゾ［１，２−Ｂ］［１，２，４］トリアジン−２−イル］ベンズアミドの錠剤 (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL) IMIDAZO [1,2-B] [1,2,4] TRIAZIN-2-YL] BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 22046659
Patent: ２－フルオロ－Ｎ－メチル－４－［７－（キノリン－６－イルメチル）イミダゾ［１，２－Ｂ］［１，２，４］トリアジン－２－イル］ベンズアミドの錠剤
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 18
Patent: صيغة قرص2-فلورو-Nميثيل -4 -[7-(كوينولين-6-يل ميثيل)اميدازو[2,1-B] [4,2,1] تريازين-2-يل] بنزاميد (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2,B] [1,2,4]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7276
Patent: TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17001177
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN- 6-YLMETIL) IMIDAZO[1,2,B] [1,2,4]TRIAZIN-2-IL]BENZAMIDA. (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL )IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE.)
Estimated Expiration: ⤷ Sign Up
Patent: 21000595
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN- 6-YLMETIL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA. (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL )IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8089
Patent: Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 170523
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2- B][1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017500121
Patent: TABLET FORMULATION OF A C-MET INHIBITOR
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 72209
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 72209
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201900648S
Patent: TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE
Estimated Expiration: ⤷ Sign Up
Patent: 201700147S
Patent: TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 72209
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2581121
Estimated Expiration: ⤷ Sign Up
Patent: 170039211
Patent: 2-플루오로-N-메틸-4-[7-이미다조[1,2-B][1,2,4]트리아진-2-일]벤즈아미드의 정제 제제 (2--N--4-[7--6-[12-B][124]-2-] TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-QUINOLIN-6-YLMETHYLIMIDAZO[12-B][124]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 230136693
Patent: 2-플루오로-N-메틸-4-[7-이미다조[1,2-B][1,2,4]트리아진-2-일]벤즈아미드의 정제 제제 (2--N--4-[7--6-[12-B][124]-2-] TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-QUINOLIN-6-YLMETHYLIMIDAZO[12-B][124]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 57523
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 24993
Estimated Expiration: ⤷ Sign Up
Patent: 1613595
Patent: Tablet formulation of a C-MET inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 2200148
Patent: Tablet formulation of a C-MET inhibitor
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 TABRECTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 201008212 | SALTS OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YL-METHYL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE AND PROCESSES RELATED TO PREPARING THE SAME | ⤷ Sign Up |
| Taiwan | 200835481 | Imidazotriazines and imidazopyrimidines as kinase inhibitors | ⤷ Sign Up |
| Israel | 229229 | מלחים של 2 - פלואורו - n - מתיל - 4 - [7 - (קווינולין - 6 - איל - מתיל) - אימידזו[[2,1-b [4,2,1]] טריאזינ- 2 - איל] בנזאמיד ותהליכים הקשורים להכנתם (Salts of 2-fluoro-n-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TABRECTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2099447 | 2022C/557 | Belgium | ⤷ Sign Up | PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621 |
| 2099447 | 53/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621 |
| 2099447 | C202230061 | Spain | ⤷ Sign Up | PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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