Viagra, The Strange Duck

Sildenafil, the active ingredient of Pfizer’s blockbuster erectile dysfunction drug Viagra, lost exclusivity in the U.S. on Nov. 6 – but don’t expect to see generic Viagra here anytime soon. 

The LOE affects only the drug’s use in pulmonary arterial hypertension (PAH), for which Pfizer sells it under the brand name Revatio.Viagra, on the other hand, continues to be protected by a use patent through April 2020, as "The Pink Sheet"’s Brenda Sandburg noted in an article on Nov. 12. It is available in 25 mg, 50 mg and 100 mg tablets; Revatio on the other hand only comes in a 20 mg strength, which is recommended to be taken three times daily. The recommended dosing for Viagra is 50 mg as needed, but not more than once daily, although depending on effectiveness and tolerance, a higher or lower dose can be taken. 

The AWP for both brands, likewise, is somewhat similar. A 90-tablet bottle (one month supply if used according to the label) of Revatio lists for  $2,107.04, with a 25% mark up on the wholesale acquisition cost, or direct price. Viagra’s AWP is calculated at 100 50 mg tablets for $2,783.49, with a 25% mark up, according to Elsevier’s The Gold Standard (roughly a three months or longer supply).

Four generic competitors have FDA-approved ANDAs for sildenafil, including Pfizer’s Greenstone subsidiary, which is selling the authorized generic. Despite the competition, the list price (AWP) for the generic appears to be only slightly discounted—but of course, the launch is only in its earliest days and AWPs don’t capture the true value of a drug, especially a generic, after rebating. 

So what’s to stop cost-conscious consumers from asking docs for generic Revatio and taking multiple tablets instead of one Viagra?

Plenty, say experts. Companies aren’t likely to promote the generic’s off label use in ED because of the threat of huge government fines for off-label promotion. Moreover, the drugs are prescribed by different kinds of doctors, who aren’t likely to try to game the system when they have nothing at stake. Pulmonary or cardiology specialists prescribe Revatio, while general practitioners primarily write scripts for Viagra, so a massive educational effort would seem to be in order, but generic companies generally do not engage in such activities on a grand scale.

Payers would be another obstacle:  private insurers aren’t likely to cover off label use of a generic when an on-label brand is available; furthermore, many require prior authorization before covering Revatio. Medicare doesn’t cover Viagra anyway, so many patients will just keep doing what they’re already doing: paying out of pocket.

That said, there’s little precedent for a drug going off patent in one indication while remaining exclusive in another; most dual brands lose exclusivity at the same time. The few examples that come to mind are old and harken back to days when the competitive landscape was quite different (Prozac and Sarafem, suggested one consultant).   

Sildenafil is an outlier because Pfizer has a use patent protecting exclusivity for ED, at least in the U.S. -- a protection that a U.S. district court reinforced last year in a ruling against Teva (Teva is appealing). However, Pfizer lost a court case over the patent in Canada on Nov. 8, so Viagra will face generic competition there shortly. 

Given the similarities, and the availability of a generic active ingredient, the question comes to mind as to whether this means much of anything for the Viagra blockbuster franchise. The question’s important to Pfizer in particular because Viagra is by far the bigger seller; its sales for the nine months ended Sept 30 were $1.5B, while Revatio sales were $414M.  

The bet is that Viagra won’t get hit too hard. In any event, Pfizer will surely be watching closely for competitors’ missteps, particularly regarding off label promotion. In the words of one consultant: “This really is a strange duck.”

Source for image: www.visualphotos.com

Pediatric Exclusivity for Viagra?! It's No Joke

You can be forgiven for skipping yesterday's Cardiovascular and Renal Drugs Advisory Committee. After an incredible series of important committee topics (Avandia! Qnexa! Opioid REMS! Avastin! Brilinta!), a day long session focused on pediatric study endpoints for pulmonary arterial hypertension drugs doesn't exactly cry out for attention.

But it was a doozy. Not so much for what the committee decided...or maybe failed to decide. Heck, this was a mess of a meeting, and our colleagues did an amazing job to make sense of the outcome in "The Pink Sheet" DAILY.

No, this was a doozy of a meeting because it is laying the groundwork for what could be a very interesting regulatory decision by FDA: granting a six-month pediatric exclusivity extension for sildenafil, the active ingredient in Pfizer's PAH drug Revatio and another product you might have heard of called Viagra.

Yes, it is true: Pfizer is (we think) going to get a six month pediatric exclusivity extension for an erectile dysfunction product. In fact, we would go so far as to say after the meeting, by any fair interpretation of how the program works, Pfizer should get an extension.

Viagra? Viagra has no role in the pediatric population--except to increase the numbers of children in the US. (Badda Bing!)


Okay, okay: the pediatric extension won't be for Viagra; it will be for Revatio--a truly important therapy for the rare but debilitating condition of PAH. And all indications are that the Pfizer product does have an important role in treating the 500-600 children in the US who suffer from the disease. Pfizer has done extensive research on that population, despite significant challenges finding a viable endpoint given that no one wants to run long-term placebo controlled trials in this setting.


The pediatric exclusivity program was created in 2002 to encourage sponsors to conduct studies in children, by granting them an extra half-year of patent life/exclusivity for completing studies pursuant to a written request by FDA. Pediatric research, everyone agrees, is a very challenging and neglected field, and the law has clearly worked to encourage many more studies than would have occured without it. The Revatio program looks exactly what the law was supposed to deliver.

But the law (as implemented by FDA) is clear: the extension applies to the active ingredient, and so--if Pfizer gets a reward--the basic sildenafil patent will be extended from March 27, 2012 until September, 2012.


That is obviously a big deal for Pfizer. Revatio sales in the US were $300 million last year, so an extra six months is nothing to sneeze at. But Viagra is almost $1 billion, so that's where all the action is. (Badda Bing!, again.)

Now, Pfizer claims Viagra will be protected from generic competition until 2019, thanks to a use patent covering the ED claim. However, use patents tend not to hold up against generic challenges, and Pfizer is already facing a challenge from Teva. On the other hand, given the unusual circumstances of Viagra's development, the use patent on ED may be more robust than most.

Nevertheless, the patent extension will still matter. Obviously it delays the earliest possible date for a generic Viagra in the event Pfizer loses the case. In the more likely event that litigation is still pending, it will delay by six months the earliest possible date that Teva could consider an "at risk" generic launch. That in turn would affect the terms of any possible settlement of the litigation (assuming pending "pay for delay" legislation in Congress doesn't put the kibosh on settlements altogether.)

The extension will also put off the date on which Pfizer will have to wrestle with the possiblity that generic versions of Revatio will start eating into the Viagra market. Revatio is marketed as a 20 mg pill, while Viagra is available as 25, 50 and 100 mg pills. As brands, Revatio retails for slightly less per pill than Viagra ($15.60 vs. $17 on drugstore.com), but it certainly doesn't make economic sense to take two Revatios instead of one Viagra. If Revatio generics are widely available, those economics could change.

So, no matter how you look at it, Viagra will benefit from the pediatric exclusivity award.

Here's the thing: the pediatric exclusivity program has strong support, but it isn't without its critics. When the program came up for reauthorization in 2007, some members of Congress wondered why a sponsor might be given an extra six months of sales for a multi-billion brand in exchange for conducting a relatively small, inexpensive study in children.

It is fair to say those arguments will come up again in 2012--especially if FDA grants an extension to Viagra, every politician's favorite target for criticizing Big Pharma.

Look for more coverage of how the advisory committee wrestled with this issue in an upcoming issue of The RPM Report.

Senate Decides Health Reform Isn't The Time To Have The Viagra Talk

Senate Republicans this week made a vigorous, though as expected unsuccessful, last ditch bid to stall the health care reform package, offering a slew of amendments of the final budget reconciliation piece of the package.

But amidst all the sweeping soliloquies about how health reform will inflict significant damage to the health care system, rest assured that one man, Sen. Tom Coburn, is keeping watch as well on some of the most arcane details.

The Oklahoma Republican offered an amendment March 25 that would restrict sex offenders' access to erectile dysfunction drugs like Viagra. It was one of 40-plus amendments were crafted specifically to make it difficult for Democrats to vote "No."

IN VIVO Blog readers may recall this is not the first time that Coburn has lobbed up an amendment to ward off misspending of health care dollars. When the Senate Health Committee was debate health reform last June, he unveiled a proposal to prevent HHS from using federal funds to sponsor fashion shows intended to raise awareness of health issues.

Now his fiscal conservatism has gone a little more hard core. Coburn's "No Erectile Dysfunction Drugs To Sex Offenders" (Amendment 3556) would prohibit federal payment for Pfizer's Viagra and other ED medications like Lilly's Cialis and Bayer's Levitra for convicted child molesters, rapists, and sex offenders. It also would prohibit coverage of abortion drugs and enact Government Accountability Office recommendations to prevent fraud via insurance claims for prescriptions written by providers who are actually dead or provided to dead patients.

It's hard to argue that sex offenders or dead people need access to ED drugs, but Finance Committee Chairman Max Baucus, D-Mont., called the amendment a "crass political stunt aimed at making 30-second commercials." Health reform "is a serious bill," Baucus said. "This is a serious debate. The amendment offered by the senator from Oklahoma makes a mockery of the Senate, the debate and the American people." The amendment was defeated 57-42.

ED drugs recurringly draw the ire of legislators, who have often prodded the Centers for Medicare & Medicaid Services to limit federal payments for such products. Since 2007, for example, CMS has instructed that such drugs are not covered by Medicare Part D for the treatment of sexual or erectile dysfunction (Pfizer markets Viagra's active ingredient sildenafil under the trade name Revatio for pulmonary arterial hypertension; that type of use is covered).
Part of the problem may be that legislators don't like ED advertisements and often try to curb them. (Alas, no fond memories of Bob Dole's time in office?) Last year, for example, House Democrat Jim Moran introduced legislation that directs the Federal Communications Commission to consider any advertisement for ED treatment or male enhancement as indecent for purposes of broadcasting between 6 a.m. and 10 p.m. Pfizer's current TV ads ask "Isn't it time you had the Viagra talk?

Despite such diversions, the Senate cleared the reconciliation bill later the same day. (For a recap of key pharma provisions, see last week's issue of "The Pink Sheet".) A couple minor education-related provisions were deleted, so the measure will need one final House vote. Meanwhile, we are eager to see what sizzling issues Coburn may similarly detect in upcoming legislative initiatives like financial reform.

- By Lauren Smith

Viagra and Mad Men: A Match Made in Heaven...

Forget "wild man." Viagra may have found the perfect marketing tie-in, at least on our local cable provider in DC: as the sponsor of "On Demand" replays of AMC's Mad Men.

If you are not a fan, Mad Men is a show about an advertising firm circa 1960 (Ad men+ Madison Avenue=Mad Men). It revels in depicting the corporate culture of that era: three-martini lunches, chain smoking executives, and sexual harassment as office sport.

What better vehicle to promote the quintessential product of the direct-to-consumer advertising era than a program about the invention of Madison Avenue itself?

The placement of Viagra on the season two premier was even more perfect. The episode in question, entitled "For Those Who Think Young," is set on Valentine's Day. And the ad break came after a pivotal scene. Here is how the episode summary describes the action:

Upstairs in their hotel room, Betty emerges from the bathroom, in heels, stockings, and a bustier. "Wow," says Don (pictured above), although later he can't pull the trigger in the midst of lovemaking. "I wish you'd just tell me what to do," Betty says afterwards. They order room service and watch Jackie Kennedy’s televised White House tour.

Cue "Viva Viagra."

There is one other reason why this sponsorship may be perfect. Mad Men's entertainment relies on the almost over-the-top behavior of its ad men--but it also makes unflinchingly clear that the world was most definitely not a better place in those "good old days."

We can't help but think that one day industry may look back on broadcast TV ads in the same light. It seemed fun at the time, but was it really the right way to do things?

Viagra for All: The Political Backlash Continues

Interesting item in the National Journal that caught our eye: the Congressional vote in 2005 to cut off federal funding for erectile dysfunction therapies has become an issue in the Missouri governor's race.

Rep. Kenny Hulshof, one of the candidates vying for the Republican nomination in Missouri, was among the minority who voted to continue paying for Viagra and the other ED therapies in Medicaid and Medicare. State Treasurer Sarah Steelman is using that vote against him, including in this campaign ad.

As we wrote at the time of the vote, the debate over federal coverage of Viagra is more than a slap in the face to the companies in that market. It is also an object lesson in the consequences of the backlash against direct-to-consumer advertising, as well as the impact of Congressional meddling in federal coverage policies now that pharmaceuticals are included in the Medicare program.

Three years later, the political potency (no pun intended) of the issue is undiminished. And Big Pharma's reputation continues to be intertwined with the ED market to an extent that should make almost everyone uncomfortable.

Bear in mind that these are two Republican candidates, neither of whom is defending the proposition that taxpayer money should support the ED market. As the Journal reports, Hulshof is fighting back against Steelman by arguing that she also voted to support Medicaid funding for Viagra at the state level.

Was it really less than a decade ago that Bob Dole was doing commercials on behalf of Pfizer about ED, and effectively defining the market as medical--not recreational? Dole, we think, is still a Republican hero in the heartland. Of course, he is from Kansas.