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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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: $31.0 million Upfront Cash: Undisclosed
Deal Type: Termination March 02, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2021
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
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.
Lead Product(s): Dimethyl Fumarate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
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