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Lead Product(s): Meloxicam
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 December 28, 2020
Details:
Meloxicam capsules, 5 mg and 10 mg, is the generic equivalent of Vivlodex capsules, 5 mg and 10 mg, of Zyla Life Sciences US, Inc., and indicated for management of osteoarthritis (OA) pain.
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Lead Product(s): Rufinamide
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 December 22, 2020
Details:
Rufinamide Oral Suspension, 40 mg/mL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.
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Lead Product(s): Dexmedetomidine Hydrochloride
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 December 14, 2020
Details:
Aurobindo's dexmedetomidine HCl in 0.9% sodium chloride injection is a therapeutic equivalent generic version of Hospira's Precedex in 0.9% sodium chloride injection.
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Lead Product(s): Paracetamol
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 23, 2020
Details:
Aurobindo Pharma has received final approval from the US Food & Drug Administration (FDA) to manufacture and market acetaminophen injection, 1,000 mg/ 100 mL single-dose vial (SDV).
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Lead Product(s): Fingolimod Hydrochloride
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 16, 2020
Details:
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).
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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
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.
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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
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.
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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
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.
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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
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®.
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Lead Product(s): Levetiracetam
Therapeutic Area: Neurology Product Name: Elepsia
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Tripoint Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 22, 2020
Details:
Under terms of the license agreement, SPARC will be eligible to receive tiered royalties ranging from 15% to 50% on net sales. Tripoint will be responsible for all US regulatory submissions and payment of annual PDUFA fees for ElepsiaTM XR 1000 mg and ElepsiaTM XR 1500 mg.
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