Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Tecfidera-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Tecfidera
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 16, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Biogen
Deal Size : $31.0 million
Deal Type : Termination
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) fo...
Brand Name : Tecfidera
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 02, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Biogen
Deal Size : $31.0 million
Deal Type : Termination
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Tecfidera-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 09, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Tecfidera
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 21, 2022
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Tecfidera
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 15, 2021
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 07, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 06, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 25, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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®.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 25, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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