Restasis Users Watch the Allergan and Imprimis Battle

If you’re a Restasis user, you’ll want to watch the Allergan and Imprimis battle.

Before we look into that, you’ll be happy to learn Imprimis announced it will soon offer a lower-cost alternative.

Watching Allergan and Imprimis Battle Over Restasis.

Allergan released a multi-dose version of Restasis a few months ago. But it charged the same high price as the single-dose vial version.

Patients have been storing what was left in the vials for later use. By squeezing out a few more drops from those single-use vials they could save some money. But a multi-dose version could end that practice, improving Restasis sales.

But what’s good for Allergan’s bottom line still left patients with hundreds of dollars a month in out-of-pocket expenses.

Allergan and Imprimis Battle

Enter Imprimis, a California-based compounding pharmacy.

Imprimis announced on October 19, 2017 that it will fill initial prescriptions of a generic version of Restasis (cyclosporine) for just 99 cents. Refills will start at $79 a month. Cyclosporine, an immunosuppressant, is the active ingredient in Restasis.

Imprimis’ is even working on a spin-off. Surface Pharmaceuticals will seek FDA approval for drugs for Dry Eye, blepharitis and other ocular surface diseases.

But the announcement prompted Allergan to file a lawsuit against Imprimis citing patent protection.

Congress Takes Notice

The patent protection saga is in itself noteworthy. Allergan transferred the Restasis patent to the Saint Regis Mohawk tribe, a Native American tribe in upstate New York. This move would quash any patent challenges filed by competing drugmakers. By default, that would extend patent protection.

According to

The pact, which will entitle the upstate New York tribe to a one-time $13.75 million payment and $15 million a year in royalties, could open up a new way for drugmakers to head off challenges to patents backing billions of dollars a year in sales.

Technology companies have used similar moves in the past.

Getting the Congressional Attention

However, Allergan’s move didn’t go unnoticed. This one even got the attention of Congress. On October 3, 2017 members of the House Committee on Oversight and Government Reform sent a letter to Allergan’s CEO Brent Saunders. The letter reads:

The sovereign status of Native American tribes adds time and complexity to contesting the status of the patents in question, because tribes may be immune from the legal claims generic drug makers use to challenge patents and bring less costly drugs to market more quickly.

The implications of Allergan’s patent transfer raise questions for Congress as the exchange may impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs.

The letter goes on to ask Allergan for detailed documentation regarding the transfer of the patent. The deadline for submitting the information was October 17.

Allergan’s battles with Congress started a day earlier. On October 2, Sen. Clair McCaskill (D-Missouri) wrote to the Pharmaceutical Research and Manufacturers of America, asking the group to investigate if Allergan’s action with the tribe was “consistent with the mission” of the trade organization.

I ask that PhRMA review whether actions to block patent challenges through claims of tribal sovereign immunity align with PhRMA efforts to promote innovation and discourage predatory pricing practices and anticompetitive conduct.

A few days later she introduce legislation to do away with the sovereign immunity defense when challenges are made to the validity of U.S. patents before the U.S. Patent and Trademark Office.

But Does It Work?

The widely-advertised treatment for Dry Eye has had issues from the start. For example, in clinical trials it was only effective in about 10-15% of patients. According to the product information sheet distributed with each prescription:

RESTASIS demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients.

So if you do the math, Restasis helped about 10-15% of trial participants. Even so, it reached the FDA efficacy threshold of 10%.

Since it’s prescribed to lots of Dry Eye patients, it’s no wonder Allergan is protecting its patent. Who wouldn’t if they stood to lose some $1.5 billion in revenue, the amount Restasis brought in last year.


Congress probes Allergan’s patent deal with Native American tribe
Helio Ocular Surgery News
October 6, 2017
View the full report

Imprimis to offer low-cost alternative to Restasis
October 19, 2017
Helio Ocular Surgery News
View the full report

Letter to Brenton L. Saunders
Committee on Oversight and Government Reform, United Stated House of Representatives
October 3, 2017
View the full report

A Native American tribe, a drugmaker and an unusual patent plan
C Koons, S. Decker
September 8, 2017
View the full report

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