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Bayer AG

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Mirena® from Bayer Approved in the US For Extended Duration of Use in Contraception

Details:

Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus.

Lead Product(s): Levonorgestrel

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena

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 August 18, 2022

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Bayer AG

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Organon Acquires Contraceptive Products, Marvelon® and Mercilon®, in the People’s Republic of China, Including Hong Kong and Macau, and Agrees to Acquire these Products...

Details:

This acquisition gives Organon full global ownership of Marvelon® and Mercilon® brands (except in South Korea) by reacquiring the rights to them in these markets. Marvelon and Mercilon are currently available by prescription in Vietnam.

Lead Product(s): Desogestrel,Ethinyl Estradiol

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Marvelon

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Organon

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition February 16, 2022

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Bayer AG

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US FDA Approves Bayer’s sNDA for Mirena to Prevent Pregnancy for Up to Seven Years

Details:

FDA approves extension of Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years of pregnancy prevention.

Lead Product(s): Levonorgestrel

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena

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 August 25, 2021

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Bayer AG

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Bayer Submits Supplemental New Drug Application to FDA for Intrauterine Device Mirena® 52 mg

Details:

This new submission will seek to extend the indication another year for up to seven years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.

Lead Product(s): Levonorgestrel

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena

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 October 14, 2020

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