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    [{"orgOrder":0,"company":"Viatris","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mylan Brings Critical Access to the M.S Community by Launching a More Affordable Treatment Option Through a First Generic to Tecfidera\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Cadila Receives Final Approval from USFDA for Dimethyl Fumarate Delayed-Release Capsules","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Cipla","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cipla Receives Final Approval for Generic Version of Biogen IDEC Inc.'s Tecfidera\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupin Receives Approval for Dimethyl Fumarate Delayed-Release Capsules","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Grows Presence in China with The Approval of Tecfidera for The Treatment of Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Eisai","sponsor":"Biogen","pharmaFlowCategory":"D","amount":"$31.0 million","upfrontCash":"Undisclosed","newsHeadline":"Biogen Japan And Eisai Provide Update On Co-promotion Of Multiple Sclerosis Treatments In Japan","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Patent Office Grants Patent Related to TECFIDERA\u00ae (Dimethyl Fumarate)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Receives FDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA\u00ae (dimethyl fumarate) Regulatory Data and Marketing Protection","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Accord healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Centralized Marketing Authorizations of Generic Versions of TECFIDERA\u00ae are Revoked by the European Commission","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]

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              Accord healthcare

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              Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission

              Details:

              Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 19, 2023

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              Biogen

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              Flag U.S.A
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              Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection

              Details:

              Tecfidera (dimethyl fumarate) have been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 16, 2023

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              Eisai

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              Biogen Japan And Eisai Provide Update On Co-promotion Of Multiple Sclerosis Treatments In Japan

              Details:

              After the termination, Biogen Japan will have full responsibility for all operations related to the products including Tecfidera® (dimethyl fumarate), Tysabri® (natalizumab, genetic recombinant) and Avonex® (interferon beta 1a, genetic recombinant) for MS treatment.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Biogen

              Deal Size: $31.0 million Upfront Cash: Undisclosed

              Deal Type: Termination March 02, 2023

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              Aurobindo Pharma Limited

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              Aurobindo Receives FDA Approval for Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg

              Details:

              Dimethyl fumarate is believed to act centrally by enhancing the nuclear factor erythroid 2 related factor 2 (Nrf2) transcriptional pathway, which regulates enzymes to counter act oxidative stress.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 09, 2023

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              Biogen

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              European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate)

              Details:

              TECFIDERA(dimethyl fumarate), a treatment for MS in adults has been shown to reduce rate of MS relapses, slow progression of disability and impact number of MS brain lesions, while demonstrating well-characterized safety profile in people with relapsing forms of MS.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 21, 2022

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              Biogen

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              Flag U.S.A
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              Biogen Grows Presence in China with The Approval of Tecfidera for The Treatment of Relapsing Multiple Sclerosis

              Details:

              First introduced in 2013, TECFIDERA has demonstrated a well-established safety and efficacy profile with more than 10 years of data from clinical trials and real-world experience.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Tecfidera

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 15, 2021

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              Glenmark Pharmaceuticals

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              Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg

              Details:

              Glenmark has received final approval by the U.S. FDA for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, the generic version of Tecfidera1 Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 07, 2020

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              Lupin Ltd

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              Lupin Receives Approval for Dimethyl Fumarate Delayed-Release Capsules

              Details:

              Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, are indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 06, 2020

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              Zydus Lifesciences

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              Zydus Cadila Receives Final Approval from USFDA for Dimethyl Fumarate Delayed-Release Capsules

              Details:

              The USFDA granted approval following entry of judgment in favor of Zydus Cadila and other ANDA applicants by the United States District Court for the District of Delaware, holding that the only unexpired patent covering Tecfidera® is invalid.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 25, 2020

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              Cipla

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              Cipla Receives Final Approval for Generic Version of Biogen IDEC Inc.'s Tecfidera®

              Details:

              Cipla’s Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.’s Tecfidera®.

              Lead Product(s): Dimethyl Fumarate

              Therapeutic Area: Neurology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 25, 2020

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              Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.
              Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
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