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In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.

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Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.

Common side effects reported from Viagra use include:

  • Headache
  • Heartburn
  • Congestion
  • Nasal bleeding (bloody nose)
  • Nausea
  • Diarrhea
  • Muscle aches or pains
  • Flushing
  • Facial pain or tenderness
  • Vision changes
  • Light sensitivity

More severe side effects include:

  • Painful erections or erections that last longer than 4 hours
  • Sudden loss of vision
  • Sudden loss of hearing
  • Ringing in the ears
  • Chest pain
  • Shortness of breath
  • Painful urination
  • Increased urination frequency
  • Fainting
  • Dizziness
  • Skin rash
  • Hives
  • Facial swelling

If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.

As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.

Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.

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This list is not a complete listing of all medications and ingredients. It is intended only for ways to determine if this list is a correctings of all listings on the Internet. It is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns, talk to your health care provider.

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Viagra generic entry

The story of Viagra’s patents and generic entry of sildenafil citrate is a valuable one because it covers many of the nuances of drug patenting and generic entry in the United States.

This article will describe the multiple patents, patent term extension, pediatric extension, litigation, out-of-court-settlement, and authorized generic fighter brand elements which led to Viagra’s long patent life and limited early entry of generics, and Pfizer’s post generic-entry strategy to limit the impact of competitors.

Protecting Viagra with Multiple Patents and Patent Extensions

Viagra patent 6,469,012

was approved in 1998, and the original patent covering Viagra was, which received a 283-day patent term extension giving it an expiration date of March 29th, 2012. This 14-year patent life is longer than many other drugs, but Pfizer was able extend the patent-protected life even further.

The ‘534 patent was filed in 1990, and in 1994 (four years prior to Viagra’s launch) Pfizer filed a second patent:. Because the ‘012 patent was filed prior to June 8th 1995 its term is17 years from the grant date, rather than20 years from the filing date, which is how expiration is determined for patents filed after Jun 8th 1995. The ‘012 patent was granted on October 22nd, 2002, so the original expiration date was set to October 22nd, 2019 — more than twenty years after the drug’s launch. The patent’s expiration was extended to April 22nd 2020 because Pfizer responded to an FDA request to perform pediatric clinical trials, granting six months of “” protection.

Patent Challenges and Out of Court Settlement

Pfizer v. Teva – Viagra patents

Pfizer successfully defended Viagra’s patents in many over the years, but one lawsuit stands out. Despite prevailing in awhich affirmed the validity of patent 6,469,012, in 2013 Pfizer announced an, granting Teva a license to manufacture and sell genericstarting in December 2017, more than two years before Viagra’s patent expiration. Importantly, this was not a ‘‘ patent settlement, as Teva was required to pay Pfizer a licensing fee to produce the generic.

Launching an Authorized Generic to Fight Generic Entry

Revatio drug price

Generic drugs sell at a discount to the branded version, which hurts branded revenues, but there are things which brands can do to limit the impact. A popular tactic it to launch an. In this strategy the branded firm licenses a third party to market the branded drug under another name, compelling the generic entrant (in this case Teva) to compete in the generic market. The authorized generic for Viagra was and it was.

What About Viagra’s price?

Viagra price trends

Viagra’s 2016 US sales were approximately 1.2 billion, and in 2017 they dropped to less than $800 million. With increased competition from Teva and from Revatio, revenues are expected to keep dropping, and widespread generic competition from the many companies with will further-decrease Viagra sales. It appears that Pfizer is responding to increased competition by increasing Viagra’s price — the has been a general increase over time.

Lessons for Predicting Generic Entry

Viagra tentative approvals

The story of Viagra and the generic entry of sildenafil citrate illustrates the value of data and the need to continuously re-evaluate factors affecting generic entry. Reliance on the first patent would have vastly under-estimated the date of generic entry, and looking solely at the expiration date of the second patent would have missed the December 2017 generic entry. DrugPatentWatch offers the tools to continuously track patents covering drugs, litigations, tentative generic approvals, and other factors essential to making better decisions. For more information, and learn more about our.

Revatio generic entry.

OTAL contribution

The information is intended to serve as a summary of the information about the licensed product(s). It is not intended to substitute for the information that was originally provided to you.

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