Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tecfidera-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 19, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tecfidera-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 01, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tecfidera
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 16, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
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...
Product Name : Tecfidera
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 03, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Biogen
Deal Size : $31.0 million
Deal Type : Termination
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 ...
Product Name : Tecfidera
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 21, 2022
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tecfidera
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 15, 2021
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Dimethyl Fumarate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 25, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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®.
Product Name : Dimethyl Fumarate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 25, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dimethyl fumarate delayed release capsules 120 mg and 240 mg are indicated for the treatment of relapsing forms of multiple sclerosis (MS), and are the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S.
Product Name : Dimethyl Fumarate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 19, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Dimethyl Fumarate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 10, 2020
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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