Dabrafenib mesylate - Generic Drug Details
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What are the generic sources for dabrafenib mesylate and what is the scope of patent protection?
Dabrafenib mesylate
is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dabrafenib mesylate has one hundred and seventy-two patent family members in forty-five countries.
There is one drug master file entry for dabrafenib mesylate. One supplier is listed for this compound.
Summary for dabrafenib mesylate
| International Patents: | 172 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Clinical Trials: | 14 |
| Patent Applications: | 224 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dabrafenib mesylate |
| DailyMed Link: | dabrafenib mesylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dabrafenib mesylate
Generic Entry Dates for dabrafenib mesylate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for dabrafenib mesylate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;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 dabrafenib mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| Pediatric Brain Tumor Consortium | Phase 1/Phase 2 |
| Alphacait, LLC | Phase 2 |
Pharmacology for dabrafenib mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-002 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806-001 | May 29, 2013 | RX | 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 dabrafenib mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012072155 | 5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO[2,3-D]PYRIMIDINE DERIVATIVE AND RELATED COMPOUND FOR TREATING CANCER | ⤷ Try a Trial |
| Peru | 20091952 | COMPUESTOS DE TIAZOLE Y OXAZOLE DE SULFONAMIDA DE BENZENO | ⤷ Try a Trial |
| Russian Federation | 2640180 | Способ адъювантного лечения рака (METHOD FOR ADJUVANT THERAPY OF CANCER) | ⤷ Try a Trial |
| European Patent Office | 1894932 | Dérivés de 5-amino-2, 4, 7-trioxo-3, 4, 7, 8-tétrahydro-2H-pyrido[2,3-d]pyrimidine et composés apparentés pour le traitement du cancer (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) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dabrafenib mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1761528 | 68/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702 |
| 1761528 | 205 5032-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702 |
| 1761528 | C01761528/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016 |
| 1761528 | PA2014039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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