Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Recipient : TherapeuticsMD
Deal Size : $225.7 million
Deal Type : Licensing Agreement
TherapeuticsMD Completes Transaction to License Its Products to Mayne Pharma
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.
Brand Name : Imvexxy
Molecule Type : Small molecule
Upfront Cash : $140.0 million
January 03, 2023
Lead Product(s) : Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Recipient : TherapeuticsMD
Deal Size : $225.7 million
Deal Type : Licensing Agreement
Lead Product(s) : Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : TherapeuticsMD
Deal Size : $225.7 million
Deal Type : Agreement
TherapeuticsMD Announces Definitive Agreements to License its Products to Mayne Pharma
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.
Brand Name : Imvexxy
Molecule Type : Small molecule
Upfront Cash : $140.0 million
December 04, 2022
Lead Product(s) : Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : TherapeuticsMD
Deal Size : $225.7 million
Deal Type : Agreement
Lead Product(s) : Isotretinoin
Therapeutic Area : Dermatology
Study Phase : Approved
Recipient : Upsher-Smith Laboratories
Deal Size : Not Applicable
Deal Type : Not Applicable
Upsher-Smith Launches Three Additional Strengths Of Isotretinoin Capsules
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.
Brand Name : Isotretinoin-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 28, 2021
Lead Product(s) : Isotretinoin
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Upsher-Smith Laboratories
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Mithra Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Nextstellis® Receives FDA Marketing Exclusivity and Phase III Data Published
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).
Brand Name : Nextstellis
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 27, 2021
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Mithra Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
New Efficacy Data Reinforces NEXTSTELLIS® Benefits Across Patient Populations
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.
Brand Name : Nextstellis
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 30, 2021
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Mithra Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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 o...
Brand Name : Nextstellis
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 06, 2021
Lead Product(s) : Drospirenone,Estetrol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Mithra Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Chlorzoxazone
Therapeutic Area : Musculoskeletal
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mayne Pharma Launches Chlorzoxazone Tablet in the United States
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 28, 2020
Lead Product(s) : Chlorzoxazone
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
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.
Brand Name : E4/DRSP
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 24, 2020
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA
Details : Mayne Pharma has submitted a New Drug Application to the US FDA, seeking marketing authorisation for E4/DRSP.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 16, 2020
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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