Indivior: Suboxone Tablets, Film and the Fight Over Generic Competition

In the Indivior Suboxone product hopping case, the company agreed to a $102.5 million state settlement over allegations that it moved prescriptions from tablets to film to block cheaper generic competition. The states reported annual Suboxone sales topping $1 billion during the alleged suppression of generic competition.

The alleged strategy reached across sales, pricing, rebate contracts and dealings with the Food and Drug Administration. A tablet generic could compete for a tablet prescription. Moving that prescription to film changed the market the generic would enter, and the purchasers alleged that Indivior worked to make the old tablet market disappear.

Suboxone treats opioid addiction. Indivior, formerly Reckitt Benckiser Pharmaceuticals, manufactured the tablets and developed an under-the-tongue film as the tablets’ exclusivity period approached its end. Direct purchasers challenged the switch and the accompanying conduct under antitrust law. State attorneys general brought their own action, which produced the settlement announced in June 2023.

Why a Generic Tablet Could Miss the Film Market

A pharmacist could substitute a generic tablet for branded Suboxone tablets, but a film prescription did not carry that substitution requirement. The Third Circuit’s account of the products explains why changing the dosage form mattered commercially.

Suboxone tablets entered the market in 2002 with seven years of exclusivity. As that period neared its end, the company developed film, which would have its own exclusivity period. The states alleged that generic alternatives might otherwise have become available in late 2009.

For pharmacy substitution, the generic must match the brand’s ingredient, strength, dosage form and route of administration. The Food and Drug Administration’s AB rating identifies that equivalence. State laws allow or require pharmacists to substitute those lower-cost generics for the corresponding brand.

Suboxone tablet generics would not be AB-rated to the film. A prescriber’s decision to move a patient to film therefore affected the generic manufacturer’s opportunity to compete later. That is the commercial hinge of this case: the alleged effort to move demand away from the product the generic could replace.

In the pharmaceutical business, approval and access are separate hurdles. A generic developer also needs supply, distribution and a place in the payer’s coverage arrangements. In Suboxone, the purchasers alleged that the brand used several of those commercial decisions together to keep the cheaper tablet from gaining a foothold.

Suboxone Film, Tablet Rebates and REMS Allegations

Indivior’s Suboxone film strategy, tablet rebates and REMS conduct formed parts of the same alleged plan to suppress generic tablets. The purchasers’ account connected the safety message, the cost of the old product, its withdrawal and obstacles to approval of its generic replacement.

Safety Claims Prepared the Tablet Withdrawal

The purchasers alleged that the company ran a widespread campaign falsely portraying Suboxone tablets as more dangerous to children and more prone to abuse. They also alleged that it publicly announced plans to withdraw the tablets because of those safety concerns, then removed the branded tablets from the market.

The same company that sold the tablets allegedly used their supposed dangers to sell the replacement. That message gave prescribers a reason to move patients to film while the tablet was still available. The states alleged that the switch followed this sequence: after most Suboxone prescriptions had shifted to film, the company removed the tablets from the U.S. market.

That sequence matters to someone who worked on a product transition. The safety assessment, the message delivered to prescribers and the commercial plan belong in the same comparison. Here, the purchasers alleged that the message helped empty the market a tablet generic was preparing to enter.

The Rebate Moved to Film and the Tablet Price Rose

The purchasers alleged that Indivior ended its tablet rebate contracts with managed care organizations in favor of film rebate contracts. They also alleged that it raised tablet prices above film prices.

Those decisions worked on the buyer’s side of the switch. Under the alleged arrangement, continuing with the old form meant facing the higher tablet price after the tablet rebate contract ended. The rebate relationship moved to film. The same company allegedly made its established product less attractive while promoting the replacement that generic tablets could not automatically substitute for.

A pricing team would see the list-price decision. A contracting team would see which rebate ended and which agreement replaced it. Reading those decisions together explains the alleged commercial pressure better than either document on its own.

Shared Safety Work and a Citizen Petition Reached the FDA

The purchasers further alleged that Indivior manipulated the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy process, commonly called REMS, and filed a baseless citizen petition to impede and delay generic tablets.

The court explained that the Food and Drug Administration’s safety requirements can include medication guides and communications to healthcare providers. When a generic needs a REMS program, the agency can require its developer to coordinate with the brand on a shared program. That puts a prospective competitor and the incumbent at the same table before the generic reaches the market.

A citizen petition gives a person or company a way to raise concerns with the Food and Drug Administration about a drug approval. In this case, the purchasers alleged that the petition and failure to cooperate on REMS helped delay the generic tablets. The alleged market shift and the alleged approval obstacles served the same objective: fewer customers waiting for the tablet generic when it arrived.

What the Price and Rebate Records Reveal

The purchasers’ theory depended on comparing what buyers paid with what they would have paid if generic tablets had competed. A discount on film could look attractive beside a more expensive branded tablet while leaving buyers worse off than access to a cheaper generic would have done.

The market-access role of manufacturer rebates helps explain why the contracts matter. In its 2020 paper The Association Between Drug Rebates and List Prices, the USC Schaeffer Center studied estimated rebates and list prices for 1,335 U.S. brand-drug National Drug Codes from 2015 through 2018. It found that increases in rebates were associated with increases in list prices, with a stronger relationship among drugs without generic competition.

The paper explains how a rebate can favor the more expensive choice:

For Suboxone, the important comparison was the alleged move from rebated tablets to rebated film, alongside tablet price increases and the availability of generic tablets. We examine the contract’s effective dates, the product it covers and the price after concessions alongside the product-transition plan. The rebate’s size means little without knowing which product the arrangement helped displace.

How Buyers Used Indivior’s Own Pricing Data

The buyers’ economic expert used internal company documents describing the national Suboxone strategy, tablet-pricing analysis and company sales data. The model compared actual branded tablet and film prices with the prices purchasers would have paid for generic and other competing versions. The alleged injury was the extra amount buyers spent because generic tablets could not compete as they otherwise would have.

Indivior sought to separate the price and rebate decisions from the rest of the alleged conduct. The court instead considered the purchasers’ theory as a whole: raising tablet prices, moving rebates to film, disparaging tablets, withdrawing them and obstructing generic entry allegedly worked together to suppress competition.

The State Settlement Reached Future Product Changes

The June 2023 state settlement required a payment to the participating states and the District of Columbia, restrictions on similar product hopping and notice of specified future business decisions. The District’s announcement identified new Suboxone drug applications, citizen petitions, new products and changes in corporate control as events Indivior would have to disclose.

Those terms reached back into the business functions involved in the alleged switch. A new dosage form, a regulatory petition and a product launch would receive scrutiny beyond the commercial team making the decision. The resolution addressed future conduct as well as money.

The state’s description also identifies who allegedly lost. People seeking treatment for opioid addiction paid more for Suboxone or went without treatment, while generic competitors faced an allegedly obstructed market. The product at the center of the dispute treated addiction. The alleged strategy made access to a cheaper version harder.

Other Suboxone Payments Concerned Government Claims

The same drug also appeared in separate pharmaceutical fraud settlements over marketing that allegedly caused false government claims. Reckitt Benckiser Group, Indivior’s former parent, reached a $700 million civil settlement in 2019. Indivior’s separate civil settlement in 2020 was $300 million and concerned alleged Suboxone safety and marketing representations causing false claims.

Whistleblowers brought the False Claims Act cases resolved by those civil agreements. Those cases pursued the government’s money. The direct-purchaser antitrust case pursued buyers’ alleged overpayments, and the state antitrust settlement resolved the states’ claims.

What an Insider Can Connect

The Suboxone purchasers connected internal commercial strategy with transaction records. Burlington Drug, one of the direct purchasers, produced electronic data showing tablet purchases, chargebacks and sales, together with employee files. The buyers’ expert paired company strategy documents with pricing and sales data to examine the alleged overcharges.

That is a useful way to think about the information scattered across a pharmaceutical business. A market-access employee may see the rebate contract and the intended shift in prescribing. A medical or regulatory employee may know the basis for the safety message and the shared-program discussions. A buyer may see how price, availability and purchases changed. We work with insiders to connect those views to the decisions and payments they explain.

For a pharmaceutical whistleblower case about Medicaid health care payments, the connection to false claims is central. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know Why the Product Changed

If you know how a safety message, rebate decision or product withdrawal affected Medicaid-paid prescriptions, speak to one of our whistleblower experts about why the product changed. We work with you to build your strongest pharmaceutical whistleblower case, bring in pharmaceutical whistleblower lawyers who understand drug marketing and government payments, and remain your partners throughout it.