.... okay... I'm a dingbat....
.... but..... so.... what is Sanofi's gain then? At the time they were trying to compete against Mylan they were charging the same and insurance companies would cover the Auvi-q. And, had a failed product that had to be pulled from the market. So, inherently they were charging the same for defective products.
Firstly, Sanofi alleges they pulled the Auvi-Q out of an abundance of caution over potential
dosage issues, then chose to revert the rights. Believe what you want and read between the lines, but the success/marketshare and ability to price a product have a lot to do with your break-even. Less marketshare against fixed development costs? Incentive to cut your losses. Sanofi likely cut their losses.
Also, between what was known at the time Auvi-Q was on market vs. now (with all of the Mylan hate/probing)... plus you can sue for past damages.
Alright, not a lawyer, skimming the brief, who knows what holds up in court or what settlement is reached. I'm just reading what Sanofi is alleging and trying to distill it.
Sanofi is arguing that Auvi-Q was generally a Tier 2/Tier 3 drug on 3/4 tier drug plans in the US. It wasn't generic (Tier 1) but was preferred brand or at least not higher tier non-preferred, and copay programs kept it affordable ($0 generally) for consumers.
Starting Spring 2013, Mylan starts negotiating huge rebates to third party payors of 30% or more if Auvi-Q will be the only covered Epinephrine device in the formulary. (Basically, Adrenaclick, Twinject, Auvi-Q, etc. are not covered drugs) only covering Auvi-Q if it was under an extremely restrictive prior authorization. Rebates are a fact of life but large rebates to exclude competition aren't kosher. Mylan started the price hikes (according to sanofi) before EpiPen ever launched - then, once Auvi-Q provided an actual threat, they made up for the price hikes with massive rebate schemes that weren't there before. Key part is the exclusivity on the rebates - you want the rebate, you agree EpiPen is the only autoinjector you cover. EpiPen already had massive brand awareness/marketshare and Auvi-Q was not A/B rated, so it was hard for third parties to ignore the amount of discounting.
Between marketshare (13% at peak) and trying to make up the cost of innovating in the autoinjector market (e.g. cost of development/royalties) Sanofi says they could not intend nor possibly match the EpiPen rebating. Sanofi says once Mylan started the exclusivity scheme, 50% or more of insured patients lost access to Auvi-Q within 2 months (December 2013/Jan 2014). Due to the tiering mentioned earlier, Sanofi had to pay far more per patient to get them $0 copay at the counter than Mylan did.
Moving quicker: Mylan required schools to not stock other autoinjectors to get free EpiPens, Mylan ripped off Medicaid, Sanofi took a bath on Auvi-Q because of anticompetitive actions by Mylan. Mylans conduct hurt consumers for lack/suppression of a better product and them paying for it, third party payors being blindsided by Mylan, etc.
Regarding Kaleo, unless there's some massive secret rebate scheme I don't get why PBMs would pay for Auvi-Q as is. Rebates to PBMs are kept wholly, in part, or not at all by the PBM instead of the plan payer. In a large group plan, rebates go entirely back to the large group payer. In other plans, PBMs keep most of it. I suspect on smaller plans (individual health/smaller employers) the PBMs are paying a large sticker and getting 50%+ of the Auvi-Q purchase price back, which at $4500 a two pack is $2250. I suspect that Kaleo will ultimately end up in similar trouble for different reasons (not allegations from a competitor but some aggrieved parties (companies, plan payers [employers], etc.) filing suit, if there's not some sort of congressional investigation due to the general outrage of drug pricing and ballooning medical costs in this country.