What Happened
On January 16, Attorney General (AG) Jason Miyares’s last day in office, the Virginia AG reached a settlement with Viatris, Mylan’s corporate successor, over EpiPen pricing and related practices. The settlement was filed and approved by the Circuit Court for the City of Richmond without issuance of a press release by the Virginia AG.
Viatris agreed to pay $6.25 million and undertake consumer‑facing measures, while denying liability, and Virginia granted a broad release tied to a defined set of “Covered Conduct” related to EpiPen pricing, marketing, and contracting through the agreement’s effective date. Notably, Viatris committed to increase its co-pay coupon from $25 to $40 for its generic EpiPen, contingent upon the company reaching resolutions with other states for which settlement discussions are ongoing.
The Details
Because Virginia law provides that its pre-litigation settlements (assurance of voluntary compliance) be accompanied by a lawsuit, Virginia’s complaint provides a good background of the Commonwealth’s allegations — which relate to Mylan’s conduct after acquiring U.S. rights to EpiPen in 2007. The Commonwealth alleged that Mylan raised the list price of a two‑pack from about $100 to more than $600 by 2016 without meaningful product changes, and simultaneously eliminated single‑pen sales in the U.S. while continuing to sell single pens abroad. Virginia contends this effectively forced consumers to buy two devices and that marketing materials did not clearly explain when a second pen was medically necessary.
The complaint also challenges Mylan’s contracting and rebate practices, alleging that Mylan secured preferred or exclusive formulary status through conditional rebate arrangements with PBMs, funded by higher list prices, which disadvantaged competitors and led to “supracompetitive” pricing. Rather than framing these issues solely as competition concerns, Virginia characterizes them as deceptive and misleading practices under state consumer protection law, asserting that Mylan’s statements about pricing, product configuration, and EpiPen’s advantages over alternatives misled consumers and payors.
Under the parties’ assurance of voluntary compliance, Viatris agreed to pay $6.25 million to Virginia, in full satisfaction of the Commonwealth’s allegations.
The settlement also imposes consumer‑facing nonmonetary obligations. Viatris agreed to enhance and promote co‑pay assistance for the authorized generic EpiPen, increase awareness of coupons and patient assistance programs in Virginia, and continue and promote school‑based epinephrine access initiatives. It also committed to donate EpiPen devices to the Commonwealth in an initial year and for additional years thereafter, with details to be negotiated in good faith.
In exchange for the payment and undertakings described above, the Commonwealth releases all civil claims it has, may have, or could have asserted — whether known or unknown — relating to the covered conduct, subject to important carve‑outs (including claims to enforce this assurance, any criminal liability, state false‑claims and Medicaid fraud/abuse or kickback claims, and any state or federal tax or securities violations). Notably, the release language is broad in both scope and time. “Covered Conduct” is defined to encompass the conduct alleged in the complaint — including EpiPen pricing, the shift to two‑pack‑only sales, and rebate and formulary practices with PBMs and payors — as well as additional EpiPen‑related activity, such as donation and school programs, alleged strategies relating to generic entry and patent litigation, and public communications about EpiPen and competing products, through January 16, 2026.
Viatris, for its part, explicitly denies any wrongdoing or violation of law, and the settlement disclaims any admission that could be used as precedent in other proceedings.
Why It Matters
For pharmaceutical manufacturers that regularly face investigations and inquiries from state AGs, the Viatris settlement underscores several trends that are likely to shape future enforcement and settlement strategy.
First, the case shows how AGs are increasingly using consumer protection statutes to challenge pricing and market‑access strategies. Conduct like price hikes, product configuration changes, and PBM rebate arrangements — long familiar in federal and private litigation — is being recast as deceptive or misleading under state consumer‑fraud laws. For manufacturers, that means internal and external communications explaining product configuration, price increases, and rebate structures may be scrutinized not just for competition issues, but for how they appear to consumers, prescribers, and payors.
Second, the settlement underscores that defining “released” conduct can be as important as the dollar amount. The Virginia assurance carefully delineates covered conduct to secure meaningful peace around EpiPen‑related issues within the Commonwealth, while preserving space for other enforcement noted above (such as criminal or false claims matters). For similarly situated companies, the settlement addresses current allegations and foreseeable follow‑on theories.
Third, the structure and presentation of relief reflect what many AGs increasingly want from pharmaceutical settlements. The $6.25 million payment is significant, but much of the public‑facing value lies in the narrative about improved affordability and access — enhanced co‑pay assistance, promotion of patient and school programs, and product donations to the state. For manufacturers, this means that future negotiations are likely to focus heavily on what can be offered that directly benefits patients and communities, and how those commitments will be described in public communications, even in matters that otherwise resolve without a press release.
Fourth and finally, Viatris’ decision to resolve the matter with Miyares on his last day in office positions the company to use the Virginia assurance of voluntary compliance as a strategic benchmark in ongoing negotiations with other state AGs. By securing a settlement that sets both monetary and injunctive markers — without agreeing to a most-favored-nations clause or similar parity provisions — Viatris preserves flexibility to calibrate future resolutions to the specific posture, risk, and demands of other jurisdictions. That combination of an early, contained agreement and the absence of mandatory parity terms provides meaningful strategic value as the company continues to manage parallel regulatory actions and attempts to limit both financial exposure and operational constraints across states.
