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Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: TherapeuticsMD
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Licensing Agreement January 03, 2023
Details:
Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: TherapeuticsMD
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Agreement December 04, 2022
Details:
Upsher-Smith’s product is AB2-rated to the branded product, Absorica® (isotretinoin) capsules in 10 mg, 20 mg, 30 mg and 40 mg strengths used to treat severe cystic acne.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: Isotretinoin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Upsher-Smith Laboratories
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
NEXTSTELLIS (drospirenone and estetrol tablets) indicated for use by females of reproductive potential to prevent pregnancy. Nextstellis® has been granted marketing exclusivity as a new chemical entity from the US Food and Drug Administration (FDA).
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mithra Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
NEXTSTELLIS is the first contraceptive pill containing E4, a new naturally occurring estrogen with a unique mechanism of action that offers potential advantages over other estrogens.
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
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 30, 2021
Details:
New data shows treatment with NEXTSTELLIS®,1 a novel, investigational combined oral contraceptive containing drospirenone and estetrol, resulted in less changes in endocrine markers, including lower increases in hormone binding globulins vs COCs based on ethinyl-estradiol.
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mithra Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2021
Details:
FDA has granted approval of its Abbreviated New Drug Application (ANDA) for chlorzoxazone tablet, 375 mg, 500 mg and 750 mg, in the United States.
Lead Product(s): Chlorzoxazone
Therapeutic Area: Musculoskeletal 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 July 28, 2020
Details:
New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: E4/DRSP
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
Details:
Mayne Pharma has submitted a New Drug Application to the US FDA, seeking marketing authorisation for E4/DRSP.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
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