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Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Zafemy
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 February 26, 2021
Details:
Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System.
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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: Cantor
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 11, 2021
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity).
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Lead Product(s): Acetylsalicylic Acid
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) 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 January 25, 2021
Details:
Contrary to previous findings, low-dose aspirin therapy before conception and during early pregnancy may increase pregnancy chances and live births among women who have experienced one or two prior miscarriages.
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Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena
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 December 14, 2020
Details:
FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
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Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Evra
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Gedeon Richter Plc.
Deal Size: $263.5 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 03, 2020
Details:
Evra is a transdermal contraceptive patch assets. The deal is complemented by a transitional business license agreement and series of other related agreements to run the business without interruption during the period required to transfer marketing authorizations to Richter.
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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: Cantor Fitzgerald
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 10, 2020
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products which includes IMVEXXY®, BIJUVA® and ANNOVERA®, and for working capital and general corporate purposes.
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Lead Product(s): Norethindrone Acetate,Ethinyl Estradiol,Ferrous Fumarate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Gemmily
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 November 09, 2020
Details:
Taytulla® is an estrogen/progestin combination oral contraceptive indicated for use by women to prevent pregnancy. Annual market sales for Taytulla® for the twelve month period ending August, 2020 were $157 million, according to IQVIA™.
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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Phexxi
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 September 08, 2020
Details:
Approved by the U.S. Food and Drug Administration (FDA) on May 22, 2020, Phexxi is a vaginal pH modulator designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.
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Lead Product(s): Bremelanotide
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Vyleesi
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: AMAG Pharmaceuticals
Deal Size: $16.3 million Upfront Cash: $12.0 million
Deal Type: Divestment July 27, 2020
Details:
Under the terms of the termination agreement, all of AMAG’s rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin.
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