(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 $220m 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.

Aquestive Therapeutics Overview

Aquestive Therapeutics (Aquestive), is a Pharmaceutical company. It offers drug products. The company offers products that includes sympazan, a film formulation of clobazamor for treating seizures associated with Lennox-Gastaut syndrome (LGS); suboxone for the treatment of opioid dependence; zuplenz for the treatment of nausea and vomiting; and diazepam. It also provides nutraceuticals, packaging solutions, and consumer products. Aquestive provides PharmFilm, a drug delivery platform that delivers existing prescription products directly to the bloodstream. The company collaborates with other pharmaceutical companies for the development and commercialization of its pharmaceutical products. The company has manufacturing facility in Indiana, the US. Aquestive Therapeutics is headquartered in Warren, New Jersey, the US

The company reported revenues of (US Dollars) US$50.8 million for the fiscal year ended December 2021 (FY2021), an increase of 10.9% over FY2020. The operating loss of the company was US$48.5 million in FY2021, compared to an operating loss of US$42.9 million in FY2020. The net loss of the company was US$70.5 million in FY2021, compared to a net loss of US$55.8 million in FY2020. The company reported revenues of US$11.5 million for the third quarter ended September 2022, a decrease of 13.6% 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.