Teva's Buprenorphine/Naloxone Generic Discontinued from Sale After FDA Approval
FDA Approval and Current Status
Teva Pharmaceutical Industries (TEVA)'s U.S. subsidiary, Teva Pharmaceuticals USA, received final FDA approval for its buprenorphine hydrochloride/naloxone hydrochloride sublingual tablets on September 8, 2014. ANDA 091149 was approved for two strengths: 2mg/0.5mg and 8mg/2mg. This approval was based on demonstrating quality and bioequivalence to the reference drug, rather than a Phase 3 clinical trial. Currently, both products are listed as discontinued, so this record should be interpreted as a past regulatory milestone rather than a new catalyst for revenue growth. The ANDA review did not involve an advisory committee (AdComm) vote.
Drug and Therapeutic Significance
The reference brand is Indivior (INDV)'s Suboxone, and the generic name is buprenorphine hydrochloride/naloxone hydrochloride. Buprenorphine is a mu-opioid receptor partial agonist that suppresses withdrawal and cravings, while naloxone is a mu-receptor antagonist that helps prevent non-oral abuse. This combination is a fully approved and marketed treatment for opioid use disorder (OUD), and is a key component of medication-assisted treatment, along with methadone and extended-release naltrexone. The low-cost sublingual formulation is easy to administer, but daily adherence and the risk of drug diversion remain commercial limitations.
Competitive Landscape
Direct competitors include Suboxone sublingual tablets/oral film, Orexo (ORX)'s Zubsolv sublingual tablets, and several other buprenorphine/naloxone generics. Long-acting competitors include Indivior's Sublocade, approved by the FDA on November 30, 2017, and Braeburn's Brixadi, approved by the FDA on May 23, 2023, which offers weekly and monthly dosing options. Non-opioid alternatives include Alkermes (ALKS)'s Vivitrol, an extended-release naltrexone injectable, and methadone, which is also an established standard of care. Therefore, the key competitive dynamic is between low-cost sublingual generics and long-acting injectables that offer improved adherence and ease of administration.
Market and Investment Implications
The global OUD treatment market was estimated at $6 billion in 2025 and is projected to grow to $6.8 billion in 2026 and $12.9 billion in 2033. However, this figure represents the overall OUD treatment market and does not reflect Teva's specific sublingual tablet sales or the buprenorphine/naloxone market alone. Given the current discontinued status of ANDA 091149, this is not an event that supports Teva's short-term financial performance or market share expansion. From an industry perspective, generic entry has increased treatment access and price competition, but the focus has shifted to long-acting formulations such as Sublocade and Brixadi.
This case involves an ANDA that received final approval on September 8, 2014, but is not a new growth driver for Teva, as the two strengths are currently discontinued. The global OUD treatment market, valued at $6 billion in 2025, is projected to grow to $12.9 billion in 2033, but the competitive focus has shifted from low-cost sublingual formulations to long-acting injectables such as Indivior's Sublocade and Braeburn's Brixadi. From an R&D perspective, adherence, dosing interval, and abuse-deterrent technologies are the key differentiators, rather than the established mechanism of combining a mu-opioid receptor partial agonist and antagonist. This case demonstrates that bioequivalence-based generics alone are not sufficient for price defense, and that manufacturing sustainability, distribution economics, and formulation innovation are key to long-term market share.
Source: openFDA (api_fda)
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=ANDA091149