FDA Approved a Generic Version of Viagra- But Will Not be Available Until 2017

[Nelson Vergel]

Posted 10 March 2016 By Zachary Brennan

Teva Pharmaceuticals will take a bite out of Pfizer's blockbuster Viagra (sildenafil citrate) sales as the US Food and Drug Administration approved a generic version of the erectile dysfunction drug on Wednesday.

But the generic savings will not come until December 2017. Teva spokeswoman Denise Bradley told Focus that because of a 2013 pay-for-delay settlement with Pfizer, Teva has agreed to not launch the generic until December 2017.

Generic giant Mylan also agreed with Pfizer not to launch its generic version of Viagra until 2017.

Israel-based Teva won FDA approval for three different strengths of the drug: 25 mg, 50 mg and 100 mg and has been selling its generic version in the EU since 2013.Teva will pay royalties through the expiration of the Viagra patent in the US in April 2020.
- See more at: http://www.raps.org/Regulatory-Focu...l-Not-Launch-Until-2017/#sthash.s98Dx27Z.dpuf

 

[Vince Carter]

More than a generic something OTC would be best but I'm sure there'd be more doom and gloom reporting of horny males with raging boners on the streets accosting females if it were OTC.

 

[Vince]

I won't believe it until it actually happens, it's all about more money for big Pharma.

 

[Jasen Bruce]

Sildenafil has also been available since 2005 in the form of Revatio 20mg tablet (also owned by Pfizer) and also as a compounded generic. Here is a summary of the current status of sildenafil, its availability, and how it is able to be compounded while the patent is still active for Viagra

If the drug is under patent then the compounder is not supposed to compound it, however there are some exceptions. Viagra was patented in 2002 and is still under protective patent until 2019 for use in treating erectile dysfunction. Although pharmacies are not supposed to compound generic Sildenafil, the raw material is still available for sale to US compounding pharmacies. This raw sildenafil powder comes from FDA approved suppliers. It is speculated that the compounding of sildenafil is not resisted/enforced against because of the fact it is compounded in such a large volume and the patent protection for Viagra is close to wearing off. At this point the patent for Viagra is a “lame duck”. A drug that remains under a ‘strong’ patent will usually result in the legal enforcement needed to prevent both compounds and branded generics from penetrating the market while the patent is active. This is their chance to rake in massive profit margins until the patent expires. On a side note, manufactures like Pfizer can pay to extend the patent- they will always assess profitability to determine if having the extension is worth the money paid to extend the patent. The makers of Viagra did not fight the patent for Revatio which is a 20mg Sildenafil indicated for pulmonary arterial hypertension instead of Erectile Dysfunction because Pfizer owns this drug too. Revatio was patented in 2005, the patent expired in 2012 opening the doors for many other generics to hit the market. New introduction of these new generic low dosed sildenadil is what you are seeing in the news. To provide a comparison of cost, the AWP for brand Viagra is $40. AWP for Revatio is $11 per tablet, and Compounded Sildenafil in any strength up to 110mg typically costs $5-$7 to the patient. The wholesale cost is far less than the AWP.

 

[IronSmith]

You guys are a wealth of information here, I'm not able to contribute much but it's sure helpful to have this forum to reference and learn from.

Well done Gents, it's appreciated!

 

[roadglide]

I also use generic Revatio from Health Wherehouse on occasion. I pay 3.40 for 100mg of Sildenafil.

 

[captq]

Why anyone would buy Viagra when you can get the same thing in a generic for a fraction of the cost
I just picked up 90 20mg tabs for $59.22 at Costco using the good RX coupon

https://www.goodrx.com/sildenafil?=...ity=90&days_supply=&label_override=sildenafil

No shipping or customs issues and made in the US

 

[Steelballs]

Ok I have a stupid question. Does it still require a prescription?

 

[captq]

Ok I have a stupid question. Does it still require a prescription?

It does in my state