When can Viagra go generic – first approval of generic drug by US FDA

Medical remedies are not cheap these days, and often, coming to the pharmacy in order to buy a branded medicament, a person is shocked by its high price. In such cases, pharmacists often offer to replace the expensive pills by cheaper ones – generic variants.

What is generic version of the medicament?

How do generic variants of medical remedies appear on the market? This usually occurs by the following scheme: a large pharmaceutical company with strong scientific and technical possibilities develops a new effective medicament. The company secures a patent for it and then starts to produce and sell it. Other companies don’t have the right to make a medicament with the same active agent (sildenafil in the case of Viagra). Generally, the term of a new patent document is twenty years from the date of issuing. After expiration of this term, an inventor company loses its exclusive rights to the medicament, but its name remains in its intellectual property. Therefore, other companies start to release medicaments with the same active ingredient but under a different name. These “twin” medicaments are called generics.
Generics can be found in pharmacies all over the world, their share in the total number of marketed drugs may reach from 25% to 80%. It seems that these indicators depend on the general welfare of the population. Generic medicaments differ from originals primarily by cost. They can be ten times cheaper than the originals. For instance, one tablet of Viagra generic may cost 5 dollars, while its branded version costs around 50 dollars.

When can Viagra go generic negotiations in US

In 2013, Pfizer (the developer of branded Viagra) reached a settlement with Teva drug-making company, according to which the latter was allowed to release a replica of the popular blue anti-impotence tablet in 2017.

Representatives of Pfizer said that the drug-maker had to pay a royalty (the amount of royalties was undisclosed) for a special license to manufacture a generic variant of Viagra.
Pfizer’s patent protection of the medicament from generic competitors will expire in 2020, nevertheless, Teva will be granted a right to release its generic variant on the US territory in late 2017. Teva USA is a large branch of Teva Industries Company based in Israel.

When can Viagra go generic decision by FDA

In March 2016, Teva got an approval from FDA. According to this approval, the company can launch a generic variant of the medicament in December 2017. Three different dosages of the medicament were approved: 25 milligrams, 50 milligrams and 100 milligrams. So, Viagra go generic in the late 2017 – in early 2018. It should be noted that there are at least 9 other generic manufacturers wishing to obtain a permission to produce and sell copies of Viagra.

 

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