Athena Athena

X
[{"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

Menu
Loading...
Filters Filter
×
FILTER:
filter Company
    filter Sponsor
      filter Country
        filter Therapeutic Area
          filter Study Phase

            Active Filter(s):

            Companies By Therapeutic Area

            Development Status

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity
            Post Enquiry
            POST ENQUIRY