Generic Braftovi Availability

Last updated on Apr 10, 2025.

Braftovi is a brand name of encorafenib, approved by the FDA in the following formulation(s):

BRAFTOVI (encorafenib - capsule;oral)

Manufacturer: ARRAY BIOPHARMA INC
Approval date: June 27, 2018
Strength(s): 50MG (discontinued) ^[RLD], 75MG ^[RLD]

Is there a generic version of Braftovi available?

No. There is currently no therapeutically equivalent version of Braftovi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Braftovi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Compounds and compositions as protein kinase inhibitors
Patent 10,005,761
Issued: June 26, 2018
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Array BioPharma Inc.
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- August 27, 2030
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  Patent use: TREATMENT OF MELANOMA
- August 27, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
- August 27, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
- August 27, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- August 27, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate
Patent 10,258,622
Issued: April 16, 2019
Inventor(s): Verma Daya & Krishnamachari Yogita & Shen Xiaohong & Lee Hanchen & Li Ping & Singh Rajinder & Tan LayChoo
Assignee(s): Array BioPharma Inc.
This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methyl-sulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.
Patent expiration dates:
- November 21, 2032
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
- November 21, 2032
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
3,4-diarylpyrazoles as protein kinase inhibitors
Patent 8,541,575
Issued: September 24, 2013
Inventor(s): Pulici Maurizio & Zuccotto Fabio & Badari Alessandra & Nuvoloni Stefano & Cervi Giovanni & Traquandi Gabriella & Biondaro Sonia & "Trifiro Paolo" & Marchionni Chiara & Modugno Michele
Assignee(s): Nerviano Medical Sciences S.R.L.
3,4-diarylpyrazole derivatives of formula (I) as defined in the specification, and pharmaceutically acceptable salts thereof, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful, in therapy, in the treatment of diseases associated with a disregulated protein kinase activity, like cancer.
Patent expiration dates:
- February 26, 2030
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  Patent use: TREATMENT OF MELANOMA
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  Drug substance
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  Drug product
- February 26, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
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  Drug substance
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  Drug product
- February 26, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
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  Drug substance
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  Drug product
- February 26, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
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- February 26, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
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3,4-diarylpyrazoles as protein kinase inhibitors
Patent 8,946,250
Issued: February 3, 2015
Inventor(s): Pulici Maurizio & Zuccotto Fabio & Traquandi Gabriella & Biondaro Sonia & Trifiro′ Paolo & Badari Alessandra & Nuvoloni Stefano & Cervi Giovanni & Marchionni Chiara & Modugno Michele
Assignee(s): Nerviano Medical Sciences S.R.L.
3,4-diarylpyrazole derivatives of formula (I) as defined in the specification, and pharmaceutically acceptable salts thereof, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful, in therapy, in the treatment of diseases associated with a disregulated protein kinase activity, like cancer.
Patent expiration dates:
- July 23, 2029
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  Drug substance
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Compounds and compositions as protein kinase inhibitors
Patent 9,314,464
Issued: April 19, 2016
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Novartis AG
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- July 4, 2031
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  Patent use: TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
- July 4, 2031
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
- July 4, 2031
  ✓
  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
- July 4, 2031
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- July 4, 2031
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Patent 9,387,208
Issued: July 12, 2016
Inventor(s): Verma Daya & Krishnamachan Yogita & Shen Xiaohong & Lee Hanchen & Li Ping & Singh Rajinder & Tan LayChoo
Assignee(s): Novartis AG
This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of the formulations for treating proliferative diseases, such as solid tumor diseases.
Patent expiration dates:
- November 21, 2032
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  Drug product
Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-α inhibitor
Patent 9,474,754
Issued: October 25, 2016
Inventor(s): Caponigro Giordano & Stuart Darrin & Moutouh-De Parseval Laure
Assignee(s): NOVARTIS AG
A pharmaceutical combination comprising (a) a B-Raf inhibitor, (b) a EGFR inhibitor and, optionally, (c) a PI3K inhibitor; the uses of such combination in the treatment of proliferative diseases; and methods of treating a subject suffering from a proliferative disease comprising administering a therapeutically effective amount of such combination.
Patent expiration dates:
- August 5, 2033
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
- August 5, 2033
  ✓
  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Compounds and compositions as protein kinase inhibitors
Patent 9,593,099
Issued: March 14, 2017
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Array BioPharma, Inc.
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- August 27, 2030
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  Drug substance
Compounds and compositions as protein kinase inhibitors
Patent 9,593,100
Issued: March 14, 2017
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Array BioPharma, Inc.
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- August 27, 2030
  ✓
  Drug product
Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Patent 9,763,941
Issued: September 19, 2017
Inventor(s): Verma Daya & Krishnamachari Yogita & Shen Xiaohong & Lee Hanchen & Li Ping & Singh Rajinder & Tan LayChoo
Assignee(s): Array BioPharma, Inc.
This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methyl -sulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.
Patent expiration dates:
- November 21, 2032
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  Patent use: TREATMENT OF MELANOMA
Compounds and compositions as protein kinase inhibitors
Patent 9,850,229
Issued: December 26, 2017
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Array BioPharma, Inc.
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- August 27, 2030
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  Patent use: INDICATED IN COMBINATION WITH BINIMETINIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION
Compounds and compositions as protein kinase inhibitors
Patent 9,850,230
Issued: December 26, 2017
Inventor(s): Huang Shenlin & Jin Xianming & Liu Zuosheng & Poon Daniel & Tellew John & Wan Yongqin & Wang Xing & Xie Yongping
Assignee(s): Array BioPharma, Inc.
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- August 27, 2030
  ✓
  Patent use: TREATMENT OF MELANOMA WITH A BRAF MUTATION
- August 27, 2030
  ✓
  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
- August 27, 2030
  ✓
  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
- August 27, 2030
  ✓
  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- August 27, 2030
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  Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Compounds and compositions as protein kinase inhibitors
Patent RE49556
Issued: June 20, 2023
Inventor(s): Huang; Shenlin et al.
Assignee(s): ARRAY BIOPHARMA INC. (Boulder, CO)
The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Patent expiration dates:
- February 27, 2030
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Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- June 27, 2025 - ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- October 11, 2026 - ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- December 20, 2027 - IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
- October 11, 2030 - TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

More about Braftovi (encorafenib)

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Images

Pill A LGX 75mg is Braftovi 75 mg — Braftovi 75 mg (A LGX 75mg)