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 | ||||
| >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
Estimated Expiration: ⤷ Sign Up
Patent: 11349422
Patent: Novel pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 75803
Patent: COMBINAISON (COMBINATION)
Estimated Expiration: ⤷ Sign Up
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.
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
Patent: 130352
Patent: NUEVA COMPOSICIÓN FARMACEUTICA
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Croatia
Patent: 0191617
Estimated Expiration: ⤷ Sign Up
Patent: 0201409
Estimated Expiration: ⤷ Sign Up
Patent: 0221304
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22013
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
Patent: 08343
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Patent: 59204
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 46139
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
Patent: 4759
Patent: PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12004413
Patent: COMBINACION. (COMBINATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 13007073
Patent: NUEVA COMPOSICION FARMACEUTICA. (NOVEL PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 497
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 746
Patent: التركيبة
Estimated Expiration: ⤷ Sign Up
Patent: 883
Patent: NOUVELLE COMPOSITION PHARMACEUTIQUE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8913
Patent: Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer
Estimated Expiration: ⤷ Sign Up
Patent: 2157
Patent: Solid oral dosage form for treating cancer
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 121093
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
Estimated Expiration: ⤷ Sign Up
Patent: 140040
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE LA ACTIVIDAD DE MEK
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Poland | 2654736 | ⤷ Sign Up | |
| Portugal | 3560498 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2014039375 | ⤷ Sign Up | |
| Peru | 20121093 | COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF | ⤷ 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 | 132014902315090 | Italy | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702 |
| 1761528 | C300701 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FRAMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702 |
| 1761528 | CR 2014 00055 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702 |
| 1761528 | 300701 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702 |
| >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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