MEKINIST Drug Patent Profile
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When do Mekinist patents expire, and what generic alternatives are available?
Mekinist is a drug marketed by Novartis and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-nine patent family members in forty-six countries.
The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
DrugPatentWatch® Generic Entry Outlook for Mekinist
Mekinist was eligible for patent challenges on May 29, 2017.
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 MEKINIST
International Patents: | 169 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 92 |
Patent Applications: | 2,409 |
Drug Prices: | Drug price information for MEKINIST |
What excipients (inactive ingredients) are in MEKINIST? | MEKINIST excipients list |
DailyMed Link: | MEKINIST at DailyMed |
Recent Clinical Trials for MEKINIST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Erasca, Inc. | Phase 1 |
Peter Hosein, MD | Phase 1 |
University of Miami Sylvester Comprehensive Cancer Center | Phase 1 |
Pharmacology for MEKINIST
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for MEKINIST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MEKINIST | Tablets | trametinib dimethyl sulfoxide | 0.5 mg and 2 mg | 204114 | 1 | 2023-09-28 |
US Patents and Regulatory Information for MEKINIST
MEKINIST is protected by nine US patents and thirteen FDA Regulatory Exclusivities.
Patents protecting MEKINIST
Method of adjuvant cancer treatment
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Pyrimidine compound and medical use thereof
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Pharmaceutical composition
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Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
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Pyrimidine compound and medical use thereof
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Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
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Pharmaceutical composition
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Pharmaceutical composition
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Pharmaceutical composition
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FDA Regulatory Exclusivity protecting MEKINIST
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
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NEW PRODUCT
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PEDIATRIC EXCLUSIVITY
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PEDIATRIC EXCLUSIVITY
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TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
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TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
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TRAMETINIB IN COMBINATION WITH DABRAFENIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
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TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
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TRAMETINIB IS INDICATED IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
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PEDIATRIC EXCLUSIVITY
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PEDIATRIC EXCLUSIVITY
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PEDIATRIC EXCLUSIVITY
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PEDIATRIC EXCLUSIVITY
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ 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 MEKINIST
When does loss-of-exclusivity occur for MEKINIST?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4102
Patent: COMPRIMIDO FARMACEUTICO QUE COMPRENDE EL SOLVATO DE DIMETILSULFOXIDO DE LA N-{3-[3-CICLOPROPIL-5-(2-FLUORO-4-YODO-FENILAMINO)-6,8-DIMETIL-2,4,7-TRIOXO-3,4,6,7-TETRAHIDRO-2H-PIRIDO[4,3-D]PIRIMIDIN-1-IL]FENIL}ACETAMIDA, SU USO PARA PREPARAR UN MEDICAMENTO UTIL PARA TRATAR EL CANCER EN UN SER HUMANO Y PROCEDIMIENTO PARA PREPARAR DICHOS COMPRIMIDOS
Estimated Expiration: ⤷ Sign Up
Patent: 2185
Patent: COMPRIMIDO FARMACÉUTICO QUE COMPRENDE EL SOLVATO DE DIMETILSULFÓXIDO DE LA N-3-[3-CICLOPROPIL-5-(2-FLUORO-4-YODO-FENILAMINO)-6,8-DIMETIL-2,4,7-TRIOXO-3,4,6,7-TETRAHIDRO-2H-PIRIDO[4,3-D]PIRIMIDIN-1-IL]FENILACETAMIDA, SU USO PARA PREPARAR UN MEDICAMENTO ÚTIL PARA TRATAR EL CÁNCER EN UN SER HUMANO Y PROCEDIMIENTO PARA PREPARAR DICHOS COMPRIMIDOS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 10306653
Patent: Combination
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Patent: 11349422
Patent: Novel pharmaceutical composition
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Brazil
Patent: 2012008854
Patent: combinação, kit de combinação, uso de uma combinação, composição farmacêutica, e, método para tratar câncer em um ser humano
Estimated Expiration: ⤷ Sign Up
Patent: 2013015602
Patent: nova composição farmacèutica
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Canada
Patent: 75803
Patent: COMBINAISON (COMBINATION)
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Patent: 22701
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12000964
Patent: Combinacion de n-{3-[3-ciclopropil-5-(2-fluoro-4-yodo-fenilamino)-6,8-dimetil-2,4,7-trioxo-3,4,6,7-tetrahidro-2h-pirido-[4,3d]-pirimidin-1-il]fenil}-acetamida y n-{3-[5-(2-amino-4-pirimidinil)-2-(1,1-dimetil-etil)-1,3-tiazol-4-il]-2-fluoro-fenil}-2,6-difluoro-bencen-sulfonamida; kit; composicion; uso para tratar cancer.
Estimated Expiration: ⤷ Sign Up
Patent: 13001779
Patent: Comprimido farmaceutico que comprende el solvato de dimetilsulfoxido de n-{3-[3-ciclopropil-5-(2-fluoro-4-yodo-fenilamino)-6,8-dimetil-2,4,7-trioxo-3,4,6,7-tetrahidro-2h-pirido[4,3-d]pirimidin-1-il]fenil}acetamida; procedimiento de preparacion; y su uso para tratar el cancer.
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China
Patent: 2655753
Patent: Combination
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Patent: 3998041
Patent: Novel pharmaceutical composition
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Colombia
Patent: 31498
Patent: COMBINACIÓN QUE COMPRENDE UN INHIBIDORDE MEK Y UN INHIBIDOR DE B- RAF úTIL EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120155
Patent: COMBINACION
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Patent: 130352
Patent: NUEVA COMPOSICIÓN FARMACEUTICA
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Croatia
Patent: 0191617
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Patent: 0201409
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Patent: 0221304
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Cyprus
Patent: 22013
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Patent: 23376
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 54736
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 012000091
Patent: COMBINACIONES UTILES PARA EL TRATAMIENTO DE CANCER EN UN MAMIFERO
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Patent: 013000138
Patent: NUEVA COMPOSICIÓN FARMACÉUTICA
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Eurasian Patent Organization
Patent: 0589
Patent: ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION)
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Patent: 5198
Patent: ФАРМАЦЕВТИЧЕСКАЯ ТАБЛЕТКА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И СПОСОБ ЛЕЧЕНИЯ РАКА (PHARMACEUTICAL TABLET, PROCESS FOR PREPARING THE SAME AND METHOD OF TREATING CANCER)
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Patent: 1290149
Patent: КОМБИНАЦИЯ
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Patent: 1390913
Patent: НОВАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
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European Patent Office
Patent: 88033
Patent: Combination comprenant un inhibiteur de MEK et un inhibiteur de B-raf (Combination comprising an MEK inhibitor and a B-raf inhibitor)
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Patent: 54736
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
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Patent: 60498
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
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Patent: 08343
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
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Patent: 59204
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
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Patent: 59205
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
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Patent: 59217
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
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Hungary
Patent: 46139
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Patent: 50788
Estimated Expiration: ⤷ Sign Up
Patent: 60206
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9073
Patent: צירוף תרופתי לטיפול בסרטן (Pharmaceutical combination for treatment of cancer)
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Patent: 6855
Patent: תכשיר רוקחי (Pharmaceutical composition)
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Japan
Patent: 18929
Estimated Expiration: ⤷ Sign Up
Patent: 26014
Estimated Expiration: ⤷ Sign Up
Patent: 13508294
Estimated Expiration: ⤷ Sign Up
Patent: 14510704
Estimated Expiration: ⤷ Sign Up
Patent: 17137299
Patent: 新規医薬組成物 (NOVEL PHARMACEUTICAL COMPOSITION)
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Jordan
Patent: 94
Patent: تركيبة صيدلانية جديدة (NOVEL PHARMACEUTICAL COMPOSITION)
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Lithuania
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 54736
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 0501
Patent: NOVEL PHARMACEUTICAL COMPOSITION
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Patent: 4759
Patent: PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS
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Mexico
Patent: 12004413
Patent: COMBINACION. (COMBINATION.)
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Patent: 13007073
Patent: NUEVA COMPOSICION FARMACEUTICA. (NOVEL PHARMACEUTICAL COMPOSITION.)
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Montenegro
Patent: 497
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
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Morocco
Patent: 746
Patent: التركيبة
Estimated Expiration: ⤷ Sign Up
Patent: 883
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE
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New Zealand
Patent: 8913
Patent: Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer
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Patent: 2157
Patent: Solid oral dosage form for treating cancer
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Peru
Patent: 121093
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
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Patent: 140040
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE LA ACTIVIDAD DE MEK
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Poland
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 54736
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 54736
Estimated Expiration: ⤷ Sign Up
Patent: 60498
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 181
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
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Patent: 702
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1054
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 88033
Estimated Expiration: ⤷ Sign Up
Patent: 54736
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1202612
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up
Patent: 1304189
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1729116
Estimated Expiration: ⤷ Sign Up
Patent: 1911109
Estimated Expiration: ⤷ Sign Up
Patent: 120104547
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up
Patent: 130130028
Patent: NOVEL PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 45479
Estimated Expiration: ⤷ Sign Up
Patent: 20536
Estimated Expiration: ⤷ Sign Up
Patent: 30157
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 05828
Estimated Expiration: ⤷ Sign Up
Patent: 1249441
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5064
Patent: КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР МЭК И ИНГИБИТОР В-Raf;КОМБІНАЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР МЕК ТА ІНГІБІТОР В-Raf (COMBINATION COMPRISING THE MEK INHIBITOR AND B-Raf INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 3158
Patent: ФАРМАЦЕВТИЧНА ТАБЛЕТКА
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Uruguay
Patent: 818
Patent: NUEVA COMPOSICION FARMACEUTICA
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 MEKINIST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 52670 | DERIVATI 5-AMINO-2,4,7-TRIOKSO-3,4,7,8-TETRAHIDRO-2H-PIRIDO(2,3-D)PIRIMIDINA I SLIČNA JEDINJENJA ZA LEČENJE KANCERA (5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO[2,3-D]PYRIMIDINE DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CANCER) | ⤷ Sign Up |
Japan | 4163738 | ⤷ Sign Up | |
South Africa | 201304189 | NOVEL PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
Croatia | P20211817 | ⤷ Sign Up | |
Malaysia | 174759 | PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS | ⤷ Sign Up |
Russian Federation | 2015105821 | Способ адъювантного лечения рака | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MEKINIST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1761528 | 2014/063 | Ireland | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702 |
1761528 | 122014000102 | Germany | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, GEGEBENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | 1490063-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702 |
1761528 | 14C0083 | France | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL,HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/931 20140630 |
1761528 | C01761528/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016 |
1761528 | PA2014039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |