[{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"AUSTRALIA","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Estetrol","moa":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Mayne Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Estetrol","moa":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Mayne Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Chlorzoxazone","moa":"Intermediate conductance calcium-activated potassium channel protein 4","graph1":"Musculoskeletal","graph2":"Approved","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Drospirenone","moa":"PR","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Mithra Pharmaceuticals","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Mithra Pharmaceuticals"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Drospirenone","moa":"PR","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Not Applicable"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Drospirenone","moa":"PR","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Mayne Pharma \/ Mithra Pharmaceuticals","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Mithra Pharmaceuticals"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Upsher-Smith Laboratories","pharmaFlowCategory":"DU","therapeuticArea":"Dermatology","country":"","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Isotretinoin","moa":"RAR","graph1":"Dermatology","graph2":"Approved","graph3":"Mayne Pharma","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Dermatology","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Mayne Pharma \/ Mayne Pharma","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Mayne Pharma"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"TherapeuticsMD","pharmaFlowCategory":"D","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2022","type":"Agreement","leadProduct":"Estradiol","moa":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Mayne Pharma","amount2":0.23000000000000001,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0.23000000000000001,"dosageForm":"Insert","sponsorNew":"Mayne Pharma \/ TherapeuticsMD","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ TherapeuticsMD"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"TherapeuticsMD","pharmaFlowCategory":"D","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","country":"","productType":"Small molecule","year":"2023","type":"Licensing Agreement","leadProduct":"Estradiol","moa":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Mayne Pharma","amount2":0.23000000000000001,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","amount2New":0.23000000000000001,"dosageForm":"Insert","sponsorNew":"Mayne Pharma \/ Mayne Pharma","highestDevelopmentStatusID":"12","companyTruncated":"Mayne Pharma \/ Mayne Pharma"}]

Find Clinical Drug Pipeline Developments & Deals by Mayne Pharma

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                          01

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          02

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          03

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          04

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          05

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          06

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          07

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          08

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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

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                          09

                          Pharmtech & Ingredients
                          Not Confirmed
                          Pharmtech & Ingredients
                          Not Confirmed

                          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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