Mylan to Launch a Lower Cost Generic EpiPen

Allergic Living ^ | September 1, 2016 | Gwen Smith

[wtd]

• Mylan to Launch a Lower Cost Generic EpiPen

  Updated Sept. 1: Mylan announced on Aug. 29 that it will launch a generic version of its EpiPen at half the cost of the patented original. It plans to introduce a generic two-pack of auto-injectors for $300, compared to the list price of $609 on the branded auto-injector set.

  Facing relentless pressure from politicians, the media and social media over steep increases on EpiPens, this was the second move Mylan has made on auto-injector pricing in less than a week.

  Given that the EpiPen brand still has patent protection, the generic announcement is an unusual action for a pharmaceutical company to take. Mylan says the device and drug formulation will be identical to its branded product, and that it plans “to launch the product in several weeks, pending completion of labeling revisions.”

  The company confirmed that this is an “authorized generic,” and will not require new authorization through the FDA. In reply to Allergic Living questions, its spokesperson also said: “Mylan intends to distribute the authorized generic as it would any other generic medicine working with all parts of the generic drug value chain. The product will be available in pharmacies, just as any other generic would be.”

  On Aug. 25, the company tripled the value of an EpiPen “savings card” to $300 to assist consumers facing sticker shock at the pharmacy counter due to the high list price, coupled with either high insurance deductibles or increased drug plan co-pays.

  Several politicians had said the Aug. 25 announcement on the enhanced savings card was not enough, given that the EpiPen two-packs have risen markedly since 2007, when a pair cost about $100 compared to the current list price of $609. Sen. Richard Blumenthal (D-Conn) said: “This baby step should be followed by actual robust action.”

  Investment analysts at Sanford C. Berstein in New York called Mylan’s introduction a lower-cost generic auto-injector “a smart and real move.” In a note to clients, the analysts said they suspect the average revenue per prescription will also fall by about 25 percent.

  Company CEO Heather Bresch has indicated that she cannot control the list price set by insurers through pharmacy benefit managers, and in the generic announcement again alluded to issues with the drug pricing system. “Because of the complexity and opaqueness of today’s branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option,” she said.

  Shifting to a lower cost generic also offers relief from growing costs of EpiPens to insurers and government-funded programs such as Medicaid and Medicare. Mylan has faced mounting criticism over price increases being passed on to taxpayers.

  Some analysts also suggest the generic auto-injector also serves as a preemptive move, since politicians are urging the FDA to fast-track auto-injector competition, such as the Teva generic epinephrine device that’s in the works. As well, Kaleo has also indicated it still plans to return the Auvi-Q to the market. The Auvi-Q was voluntarily recalled in the fall of 2015, but remains approved.

[wtd]

Prior thread posted yesterday: Inside the EpiPen Price Backlash

[fhayek]

Heh. Economic competition. Who’d a thunk it?

[Secret Agent Man]

Given the price went up 5x, introducing new ones at half the price still means the “new generic” is 2.5 times more expensive than the branded product before the price hike.

[ColdOne]

$600 to $300 is still a major profit. Major profit.

[bigbob]

Half the price of the jacked-up ones, or three times the price they were a few months ago.

[bigbob]

I’m not sure you realize that this is the same company. Not really competition.

[fhayek]

Uh, yeah, I do realize it. Do you think that they did it because they watched a Care Bear movie??

[DAC21]

“600 to $300 is still a major profit. Major profit”

If Trump can get the Big Pharma protectionism and corruption out of the FDA Teva will be approved as a second source with auto injector and under cut Mylands generic by another $100 plus.

[Roccus]

“Updated Sept. 1: Mylan announced on Aug. 29 that it will launch a generic version of its EpiPen at half the cost of the patented original. It plans to introduce a generic two-pack of auto-injectors for $300, compared to the list price of $609 on the branded auto-injector set. “

---

But will this generic version qualify under the Children’s Asthma Treatment Grants Program? Will its use still entitle states to get grant $$$$$ under the new provisions?

https://www.whitehouse.gov/blog/2013/11/13/president-obama-signs-new-epipen-law-protect-children-asthma-and-severe-allergies-an

[P-Marlowe]

$600 to $300 is still a major profit. Major profit.

OMG! Profits!!!

How evil of a company to attempt to make a "profit."

These companies should be punished for being greedy.

It's just downright un-American for a company to make a profit in these socialistic times.

The Epi Pen should be free to everyone who needs it.

[encm(ss)]

From $100 to $600 is x6.
From $100 to $300 is still x3. More than enough profit.

[P-Marlowe]

From $100 to $600 is x6. From $100 to $300 is still x3. More than enough profit.

If the government got out of the business of regulating these companies into bankruptcy, then maybe drugs would be a lot cheaper.

Mylan had to invest millions of dollars in research and development and then had to clear a thousand hurdles to get this thing approved. Now FREEPERS, of all people, are bitching about them trying to make a profit.

I can't believe what I am reading here. Is this still FREE REPUBLIC?

Mylan has the patent. If you don't like it, then change the patent laws. Then nobody will even try to develop something like the Epi Pen and children will die.

[RetiredTexasVet]

A classic case of the FDA being purchased. Knock out the up front bribes required by the FDA and 5 or 6 companies could produce and offer the pens for $25 - $50 and still make a major profit.

[UCANSEE2]

Given the price went up 5x, introducing new ones at half the price still means the “new generic” is 2.5 times more expensive than the branded product before the price hike.

AND, I would bet the new 'cheaper' pen is the same pen and drug without the word EPI-PEN printed on it.

They couldn't just drop the price of the brand name pen, because that might make it look like they were GOUGING the public.

[wtd]

There's more to the story, try to keep up. The price of the actual drug, Epinephrine, remains stable. Competition for the auto-injection delivery of epinephrine dissipated in recent months while simultaneously Mylan, the sole company offering this auto-injector lobbied the govt to have schools keep 'their' product on hand at taxpayer expense. The prescribed units costed $57 in 2007 with minor increases in price till 2015 when they suddenly pushed the price to $600 The CEO of Mylan is the daughter of Senator Manchin.

Why mention Manchin?

• Politico 7/14/2016: Sen. Manchin says he's out of Dem convention, then jumps back in

  Coincidentally, the controversy over the sudden increase in cost for the EpiPen exploded at the same time.

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[P-Marlowe]

If there was quid pro quo, then the senator and the CEO daughter should both go to jail for 100 years.

[Shadow44]

This has nothing to do with My lab making a profit. It has to do with the rampant corruption, cronyism and skullduggery.

The fact is drug companies are trying to choke out competition while jacking up prices by astronomical amounts. Patients be damned.

That’s economic fascism.

[healy61]

Ask your pharmacist if any prescriptions are Mylan. If so, demand and alternative or talk to your care provider or doctor.

[George from New England]

Generic, by definition, is a product from an alternate manufacturer. No reason to allow the word generic to even be used here.
The Games Big Pharma Play