Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Updates Status of Buprenorphine Buccal Film ANDA
Details : Belbuca-Generic (buprenorphine) is a partial mu-opioid receptor agonist and kappa-opioid antagonist for severe chronic pain; it received a CRL from the FDA for its ANDA.
Brand Name : Belbuca-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 05, 2024
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Study Phase : Phase III
Recipient : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid.
Brand Name : Belbuca-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2023
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Recipient : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Study Phase : Phase III
Recipient : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Buprenorphine Buccal Film is a generic version of Belbuca®, an opioid that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
Brand Name : Buprenorphine-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 25, 2022
Lead Product(s) : Buprenorphine
Therapeutic Area : Neurology
Highest Development Status : Phase III
Recipient : IntelGenx
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Xiromed LLC Launches Gemmily™, First-to-Market Generic to Taytulla®
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™.
Brand Name : Gemmily
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2020
Lead Product(s) : Norethisterone Acetate,Ethinyl Estradiol,Ferrous Fumarate
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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