There’s both good news and bad news for the legions of men — and their love interests — who’ve waited patiently for a generic alternative to Viagra, Pfizer’s little blue pill that forever transformed the treatment of erectile dysfunction.
Nearly two decades after the Food and Drug Administration first approved Viagra in 1998, that same agency has cleared the way for the introduction of a generic version of the drug beginning in 2017.
The bad news? At the earliest, the generic version of Viagra won’t be available to users until the closing days of 2017, thus guaranteeing additional months of waiting for the start of a downtrend in prices.
Teva’s Generic Already Approved
Months ago, in March 2016, the FDA gave the green light to a generic formulation of sildenafil citrate — the active ingredient in Viagra — that Teva Pharmaceuticals proposes to bring to market in December of 2017. With that approval of the first generic version of Viagra, the agency also gave to Teva 180 days of market exclusivity during which time Teva’s generic will be the only one available.
Under FDA regulations, the first generic version of a brand-name drug to win the agency’s approval also wins roughly six months of market exclusivity. After that 180 days, other generic versions of sildenafil citrate will be allowed to enter the market.
How Much Cheaper?
Teva’s generic version will undoubtedly carry a significantly lower price tag than Viagra itself. However, because competition will be confined to Viagra and Teva’s generic for at least six months, it may not be the huge price drop Viagra users have been hoping for.
Downward price pressure will increase when other generic versions of sildenafil citrate hit the market sometime near the middle of 2018. As multiple generics compete with brand-name Viagra for market share, prices are almost certain to decline further. However, as things now stand, the very first generic competition to the little blue pill will not hit the market until the closing days of 2017.
Pfizer’s Patent Valid Till April 2020
Pfizer, which won FDA approval of Viagra in late March of 1998, holds a patent on the drug until April 2020. However, to resolve a long-running patent litigation with Teva, Pfizer in 2013 agreed to allow Teva to begin producing and distributing a generic version of the ED medication starting in December 2017. Because Pfizer’s patent on Viagra will still be in effect, Teva in return must pay Pfizer a royalty for the privilege of producing the generic until April 2020.
In 2015 Pfizer struck a similar agreement with Mylan N.V., another major generic manufacturer and distributor. Although the terms of that agreement would allow Mylan to introduce a generic formulation of sildenafil citrate no earlier than December 2017, it would seem that the Mylan generic will have to wait at least until the middle of 2018 when Teva’s market exclusivity will expire.
Teva Is a Leader in Generics
Teva Pharmaceuticals is a multinational pharmaceutical company headquartered in Israel. It manufactures and distributes both branded and generic drugs. However, it is best known for its wide array of generics, which account for roughly one in seven of all generic prescriptions filled in the United States. According to Teva’s corporate website, it produces more than 64 billion tablets and capsules every year. The company employs 58,000 employees in 60 different countries.
As previously noted, Teva’s generic formulation of sildenafil citrate has already won approval from the FDA, so it’s ready to go to market in late 2017. For those curious about how generics compare with the brand-name medications they copy, the FDA points out that generics “are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.”
FDA Requirements for Generics
To win FDA approval, a generic drug must:
- Be bioequivalent to the brand-name drug it copies.
- Contain the same active ingredient(s) as the brand-name drug.
- Have the same use indications.
- Be identical in dosage form, route of administration, and strength.
- Meet the same batch requirements for identity, purity, quality, and strength.
- Be produced under the same strict standards of FDA’s good manufacturing practice regulations for brand-name products.
While a generic’s active ingredient must be the same as that found in the brand-name drug, a generic manufacturer is not required to use the same inactive — or inert — ingredients as the brand-name drug. Inactive ingredients include substances used as fillers, coloring agents, and flavoring agents.
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