(Buprenorphine hydrochloride + naloxone hydrochloride) is a Small Molecule owned by Indivior, and is involved in 25 clinical trials, of which 21 were completed, 3 are ongoing, and 1 is planned.

Buprenorphine acts as a partial agonist at the mu-opioid receptors and as an antagonist at the kappa-opioid receptors. The binding to the mu and kappa receptors results in hyper-polarization and reduces neuronal excitability. Naloxone hydrochloride is a thebaine derivate with potent antagonistic activity at mu-opioid receptors. It binds to receptors and produces opioid withdrawal signs and symptoms including analgesia, euphoria, sedation, physical dependence.

The revenue for (Buprenorphine hydrochloride + naloxone hydrochloride) is expected to reach a total of $3.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Buprenorphine hydrochloride + naloxone hydrochloride) NPV Report.

(Buprenorphine hydrochloride + naloxone hydrochloride) is currently owned by Indivior. Aquestive Therapeutics is the other company associated in development or marketing of (Buprenorphine hydrochloride + naloxone hydrochloride).

(Buprenorphine hydrochloride + naloxone hydrochloride) Overview

Buprenorphine hydrochloride and Naloxone hydrochloride (Suboxone/ Bupradone) is a fixed-dose combination drug consisting of buprenorphine a synthetic opioid analgesic and a thebaine derivative in combination with naloxone hydrochloride as an opiate antagonist. It is formulated as tablets and film for the sublingual and buccal route of administration. Suboxone is indicated for the treatment of opioid addiction and opioid drug dependence, within a framework of medical, social and psychological treatment. Suboxone is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Suboxone was also under development as a sublingual film for opioid addiction in China.

Indivior Overview

Indivior develops and markets medicines for the treatment of opioid addiction. The company offers suboxone a monthly depot, and only approved film treatment for opioid dependence; subutex, a mono-buprenorphine sublingual tablet, sublocad injection, and nalscue for opioid use disorder; and perseris for schizophrenia. Its pipeline portfolio encompasses buprenorphine-based products, including INDV-1000 in pre-clinical phase and INDV-2000 in Phase I for substance use disorder; and AEF0117 in Phase II for treatment of cannabis disorder. Indivior offers products in the form of film, tablets, and subutex tabs. It offers its products in the US, Australia, Malaysia, France, Italy, Spain, Germany, Canada, and the UK. Indivior is headquartered in Slough, the UK.

The company reported revenues of (US Dollars) US$791 million for the fiscal year ended December 2021 (FY2021), an increase of 22.3% over FY2020. The operating profit of the company was US$204 million in FY2021, compared to an operating loss of US$163 million in FY2020. The net profit of the company was US$205 million in FY2021, compared to a net loss of US$148 million in FY2020. The company reported revenues of US$232 million for the third quarter ended September 2022, an increase of 5% over the previous quarter.

Quick View – (Buprenorphine hydrochloride + naloxone hydrochloride)

Report Segments
  • Innovator (Non-NME)
Drug Name
  • (Buprenorphine hydrochloride + naloxone hydrochloride)
Administration Pathway
  • Buccal
  • Sublingual
Therapeutic Areas
  • Central Nervous System
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.