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The long-awaited U.S. introduction of the first generic versions of Viagra came with relatively little fanfare on December 11, 2017. Given the market impact the arrival of generic alternatives to Pfizer’s iconic little blue pill is likely to have, the debut captured a few headlines but little more.
Teva Pharmaceuticals, the world’s leading generic drug manufacturer, introduced its generic formulation of Viagra, which will be marketed simply as sildenafil citrate, the active ingredient in Pfizer’s groundbreaking ED drug. It did so under a licensing agreement with Pfizer that will require Teva to pay Pfizer a royalty for the privilege of marketing a Viagra generic.
Pfizer Markets Its Own Generic
On the same day Teva’s generic Viagra debuted, Pfizer itself brought to market a generic version of its popular drug. The company’s generic alternative copies the stylized diamond shape of Viagra but is white and not the shocking blue of the original brand-name drug. Pfizer’s generic Viagra will be manufactured and marketed by Greenstone LLC, a Pfizer subsidiary that specializes in generic drugs.
Both generic versions of Viagra will be sold for roughly half the price currently posted for the brand-name drug. These less expensive alternatives to brand-name Viagra will undoubtedly capture a significant share of the Viagra market and may well tempt users of other brand-name ED drugs to switch to generics.
ED Drug Relief Now More Affordable
Because the price tags on Viagra and other brand-name ED medications have been so high, many lower income men who could use help getting an erection have simply been unable to afford them on a regular basis. The availability of generic substitutes at roughly half the price of the brand name medications could also broaden the market for such drugs by increasing the number of men who can now afford to buy them.
The way was cleared for generic competition to Viagra in the closing days of December 2013 when Pfizer struck an agreement with Teva to allow the latter to introduce a generic version of Viagra beginning on December 11, 2017. At roughly the same time, Pfizer negotiated a similar agreement with Mylan N.V., another major player in the generics market.
Pfizer’s US Patent on Viagra Still Valid
Under the terms of the agreements, the generic drugmakers recognized the validity of Pfizer’s U.S. patent on Viagra and its expiration date in April 2020. In return, Pfizer agreed to let them introduce generic formulations of the drug before 2020 in return for royalties to be paid until Pfizer’s patent expires.
These agreements came after several years of litigation over the question of Pfizer’s U.S. market exclusivity on Viagra. As early as 2010, Teva had announced its intention to market a generic version of the little blue pill as soon as possible. Pfizer went to court to stop Teva and any other upstart generic drugmakers bold enough to challenge Pfizer’s market exclusivity on the drug.
Years of discussions, in and out of court, led in late 2013 to agreements that paved the way for the introduction of Teva’s generic version of Viagra in December 2017. Under the agreement between Pfizer and Mylan, the latter could introduce its generic formulation of the drug in the near future.
Viagra Was First of Its Kind
Viagra, of course, was the first of a new class of oral medications designed to treat erectile dysfunction caused by insufficient blood flow to the penis, the single biggest cause of ED. Its 1998 approval by the U.S. Food and Drug Administration set off something of a tidal wave of print and broadcast coverage, anticipating the huge impact the drug was expected to have. And it didn’t disappoint. Although it’s hard to imagine in this era of super-candid — and often risque — marketing campaigns, one of Viagra’s earliest commercial spokesmen was former U.S. Senator Bob Dole, whose plug was plain-spoken but far from racy.
As has been the case with other important pharmaceutical discoveries, sildenafil citrate, Pfizer’s active ingredient, was first tested as a treatment for disorders totally unrelated to erectile dysfunction. The chemical formula, developed in Pfizer research laboratories in Sandwich, England, in 1989, was first considered a possible medication for angina and hard-to-control high blood pressure.
A Surprising Side Effect
Clinical trials of sildenafil citrate’s efficacy as a treatment for those original purposes produced disappointing results, but one very intriguing side effect was observed in male participants in the study. While the drug did little to relieve angina symptoms, it had a rejuvenating effect on erectile function in these men, many of whom had been diagnosed as impotent. Suddenly, those taking the new drug found it much easier to get and keep an erection.
Weighing these unanticipated — but impressive — side effects against the drug’s lackluster performance as an angina treatment, Pfizer decision makers announced that the company would take its study of the drug in a totally new direction. Several years later, sildenafil citrate made its debut as Viagra.
Prior to Viagra’s introduction, the prevailing view of male impotence held that it was primarily psychological in origin and unlikely to be treated successfully without counseling to discover the underlying cause. Viagra and the drugs that followed proved conclusively that the primary cause of ED was insufficient blood flow to the penis, accounting for up to 80 percent of all ED cases.
Levitra Makes Bow in Late 2003
Pfizer’s little blue pill had a monopoly on the ED drug market until the latter half of 2003. In August of that year, the FDA approved Levitra, the second of the so-called PDE5 inhibitors. Levitra’s approval was followed a few months later by Cialis, which distinguished itself as a far longer-acting — 36 hours vs. 4 to 6 hours — ED drug than either Viagra or Levitra.
As previously noted, the active ingredients in Viagra, Levitra, and Cialis all belong to a family of medications known as PDE5 inhibitors, so called because they temporarily sideline an enzyme known as phosphodiesterase-5 that can interfere with erectile function, particularly in men whose vascular systems have been compromised.
How PDE5 Inhibitors Work
One of the PDE5 enzyme’s primary responsibilities is to break down a substance known as cyclic guanosine monophosphate, or cGMP, a key player in erectile function. The erection process begins when the brain, responding to physical stimuli to male erogenous zones or feelings of sexual desire, sends copious quantities of nitric oxide to the pelvic region.
On its way, nitric oxide, a powerful neurotransmitter, sets off secondary chemical reactions, one of which produces cGMP, which in turn signals the smooth muscle tissue lining arteries to relax, increasing blood flow. As noted, the PDE5 enzyme breaks down cGMP, which poses no great problem in men whose vascular function is robust. As some cGMP is broken down, the body quickly produces more to replace it. However, in men whose vascular function is compromised, the PDE5 enzyme can wipe out cGMP faster than the body can replace it.
By temporarily disabling the PDE5 enzyme, Viagra and the other PDE5 inhibitors give men with vascular-related ED a window of time during which they can more easily get and keep an erection suitable for intercourse. Once the effects of these drugs wear off, these men will find it difficult, if not impossible, to achieve erection on their own.
FDA Has Strict Generic Regulations
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Under FDA’s regulations governing generic drugs, such alternatives to brand-name medications must use the same active ingredient in identical dosage form(s), strength, and route of administration. The generic may contain inactive ingredients, typically used as filler or coloring agents, that differ from those in the brand-name drug.
While Viagra is the first of the PDE5 inhibitors to face generic competition in the United States, it could be joined by one or more generic formulations of Cialis as early as late September 2018. And it’s only a matter of time before some of the other brand-name ED drugs face off against generic alternatives in the American market. Bayer HealthCare Pharmaceuticals’ main U.S. patent on Levitra expires in 2018, so its generic may hit the market not long thereafter.
ED Drugs Sold Only by Prescription
Under current U.S. regulations, all oral ED drugs, whether brand-name or generic, can be sold only by prescription. While an over-the-counter version of Viagra will go on sale in the United Kingdom in the spring of 2018, no such plans have yet been announced in this country. Your regular doctor or urologist can write a prescription for an ED drug, which can then be filled at a local pharmacy or used to order the medication from a reliable online supplier such as eDrugstore.com.
If you decide to order online, you can fax your prescription or scan and email it to eDrugstore along with your order. If you don’t have a prescription and would prefer to avoid the added cost of a visit to the doctor’s office, eDrugstore can set up a complimentary online consultation with one of its team of licensed U.S. physicians. If the consulting doctor determines you’re an appropriate candidate for the drug, a prescription will be authorized.
If online ordering appeals to you, click below to access eDrugstore’s Erection Problems page. There you will learn more about erectile dysfunction and its causes, as well as the various drugs available to treat it. These include the five brand-name ED drugs — Viagra, Levitra, Cialis, Staxyn, and Stendra — and sildenafil citrate, the newly introduced generic alternative to Viagra.
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