

Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Indivior Announces FDA Approval of New Label for SUBLOCADE® (buprenorphine) Injection
Details : Sublocade contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder.
Product Name : Sublocade
Product Type : Controlled Substance
Upfront Cash : Inapplicable
February 24, 2025
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes
Details : Sublocade contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder.
Product Name : Sublocade
Product Type : Controlled Substance
Upfront Cash : Inapplicable
February 12, 2025
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Indivior's SUBLOCADE® PAS Under Priority Review by FDA
Details : Sublocade (buprenorphine) is indicated for the treatment of moderate to severe opioid use disorder in patients.
Product Name : Sublocade
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 07, 2024
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : IntelGenx
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Belbuca-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 05, 2024
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : IntelGenx
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Buprenorphine Transdermal System is a partial opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
Product Name : Buprenorphine-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
November 02, 2023
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Preclinical
Sponsor : Alar Pharmaceuticals
Deal Size : $15.0 million
Deal Type : Licensing Agreement
Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals
Details : Under the agreement with Alar, Indivior will secure exclusive global rights (except in China, Hong Kong, Taiwan and Macau) to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates.
Product Name : Sublocade
Product Type : Controlled Substance
Upfront Cash : Undisclosed
October 11, 2023
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Preclinical
Sponsor : Alar Pharmaceuticals
Deal Size : $15.0 million
Deal Type : Licensing Agreement

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Belbuca-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
September 19, 2023
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Buprenorphine sublingual tablets, is a partial opioid agonist in combination with naloxone, an opioid antagonist, is indicated for the maintenance treatment of opioid dependence.
Product Name : Buprenorphine-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
September 06, 2023
Lead Product(s) : Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Xiromed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Belbuca-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 27, 2023
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Xiromed
Deal Size : Inapplicable
Deal Type : Inapplicable

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Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Xiromed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Belbuca-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
October 25, 2022
Lead Product(s) : Buprenorphine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Xiromed
Deal Size : Inapplicable
Deal Type : Inapplicable
