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[{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Submits New Drug Application for E4\/DRSP to the FDA","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4\/DRSP in the US","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Launches Chlorzoxazone Tablet in the United States","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Show NEXTSTELLIS\u00ae Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Efficacy Data Reinforces NEXTSTELLIS\u00ae Benefits Across Patient Populations","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nextstellis\u00ae Receives FDA Marketing Exclusivity and Phase III Data Published","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Upsher-Smith Laboratories","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Upsher-Smith Launches Three Additional Strengths Of Isotretinoin Capsules","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"TherapeuticsMD","pharmaFlowCategory":"D","amount":"$225.7 million","upfrontCash":"$140.0 million","newsHeadline":"TherapeuticsMD Announces Definitive Agreements to License its Products to Mayne Pharma","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"TherapeuticsMD","pharmaFlowCategory":"D","amount":"$225.7 million","upfrontCash":"$140.0 million","newsHeadline":"TherapeuticsMD Completes Transaction to License Its Products to Mayne Pharma","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Mayne Pharma
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Companies By Therapeutic Area
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: Approved
Product 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: Approved
Product 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: Approved
Product 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: Approved
Product 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: Approved
Product 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: Approved
Product 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: Approved
Product 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 III
Product 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 III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 16, 2020