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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.

Viagra

Pfizer

All rights reserved.

Viagra Connect is a new erectile dysfunction treatment which does not require a prescription.

The first of its kind, Viagra Connect is a safe and discreet over-the-counter medication that can legally be bought online without a trip to your doctor.

We need to ensure that this medicine is suitable for the person it is intended for. Therefore, it should only be purchased by the person taking it.

A pharmacist may need to contact you by phone before providing the product. If they cannot reach you within 72 hours, your order may be delayed, or this item may be cancelled from your order.

Please ensure your contact details are correct before ordering this medicine.Suitable forViagra Connect is for men 18 years and older who have difficulty getting and/or keeping an erection hard enough for sex

Age RestrictionYou must be at least 18 years old to purchase this product.

Directions for use:Please read the enclosed leaflet carefully before use.

• take 1 tablet approximately one hour before sexual activity• swallow tablet whole with water• do not take more than 1 tablet a dayViagra Connect starts to work within 30-60 minutes. You may take it up to 4 hours before sexual activity.

Hazards and Cautions

Do NOT take if you:

  • do not have an erection problem
  • take any nitrate medicine for chest pain or heart failure
  • take riociguat (or other guanylate cyclase stimulators) for high blood pressure in the lungs
  • take ritonavir for the treatment of HIV
  • have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels
  • have a severe heart or liver problem
  • have low blood pressure
  • have ever had severe vision loss or a rare inherited eye disease
  • have a deformed penis
  • have an allergy to any of the ingredients in this product

Talk to your pharmacist or doctor before taking if you:

  • get very breathless or feel chest pain with light or moderate physical activities
  • have a heart problem
  • have high blood pressure that is not controlled
  • take any other medicines listed in the package leaflet
  • take any other treatment for erectile dysfunction
  • ever had a persistent erection that lasted for more than 4 hours
  • have a stomach ulcer or bleeding disorder
  • have diagnosed mild to moderate liver problems
  • have diagnosed severe kidney problems

As with all medicines, please ensure you read the patient information leaflet before taking this item.

For every 3000 item has been downloaded and supplied, there are single item, non-branded "online' medicines, that can be taken easily by simple browsing and saving your "cart items" to your local pharmacy. Each item may have a "no prior order" status. Additional trackable descriptions of the products and other features of the product can be found in the patient information leaflet inside the cart.

Please note that the total cost of your order may vary depending on what items are "non-branded" within the indication. Some examples include, "stroke" and "minor malignant growth."

There are both generic and brand Viagra Connect available online in each country. You will need to "resubmit" your order before you can finalise your medicines. This can be done by calling 1-800-467-5146.

Some examples include, "stroke" and "minor malignant growth.

Sildenafil

Sildenafil, the active ingredient in Viagra, is the same in all medications. The generic version of Viagra is sildenafil citrate, which works similarly to how Viagra works. It's taken as needed, about 30 minutes before intercourse.

If you take Viagra at the same time every day, Viagra will have a lower potential for side effects compared to sildenafil citrate. However, it stays in your system for as long as four hours.

How does Viagra work

Sildenafil belongs to a class of medications known as phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing muscles found in the walls of blood vessels, which allows more blood to flow into the penis when sexually aroused. This helps produce and maintain an erection.

How long does it take for Viagra to work

Viagra typically starts to work within 30 minutes of taking a tablet. Its effects can last up to 4 hours, depending on the dose.

The best way to determine when Viagra will start to work is to take it about an hour before you plan to have sex. Viagra is a good idea to take about 30 minutes before you plan to have sex.

Sildenafil and other medications

Some medications, like sildenafil citrate, may interact with each other and cause serious side effects. These medications are usually not recommended for use during pregnancy or while breastfeeding.

You should check with a doctor or pharmacist before taking any medication if you are pregnant, planning a pregnancy, or if you have any kidney or liver problems. Your doctor may adjust the dose or recommend specific medications before sex. Ask your pharmacist about these alternatives.

Check with your doctor

Viagra should be used with caution in the following populations: women: pregnant or breastfeeding women; children: only use this medication if clearly needed; men: only use this medication if it is clearly needed.

This medication does not protect against sexually transmitted diseases (such as chlamydia, gonorrhea, syphilis).

Before taking this medication

Do not take Viagra if you are allergic to it, or if you are taking any nitrate medication, isosorbide dinitrate, any amyl or nitrates, or nitroglycerin. You must also not take Viagra if you have a recent heart attack or stroke, have a history of heart attack or heart failure, have low blood pressure, such as low blood pressure, have low blood pressure in a way that your doctor cannot affect your body that will help it, have low blood pressure that you feel is helping your condition, or have a heart problem.

Before using this medication, check with your doctor first because taking it could cause serious side effects. Your doctor will do tests to make sure you are not taking any medication that could interact with Viagra.

What if you have side effects

If you get any side effects, stop taking Viagra and let your doctor know right away.

In the case that you need more help with your condition, your doctor may need to monitor you regularly.

Side effects associated with this medication

Some side effects may be associated with Viagra. These may include:

  • headache
  • nausea
  • muscle pain
  • redness or irritation of the mouth
  • skin rash
  • trouble sleeping
  • swelling of hands or feet
  • vision changes

If you get any of these side effects, stop taking Viagra and let your doctor know right away.

Can I take Viagra with other medications

Taking Viagra with certain medications may affect how well it works.

Sildenafil citrate, commonly known by the brand name, is a prescription-only medicine used to treat erectile dysfunction (ED) in adult men. It works by improving blood flow to the penis, helping to achieve and maintain an erection during sexual activity.

Dosage and Administration

Sildenafil is available in 25mg, 50mg, and 100mg strengths.

  • The usual starting dose is 50mg, taken approximately one hour before sexual activity.
  • Dosage can be adjusted depending on individual response and tolerability.
  • Take only one tablet in 24 hours, with or without food.
  • Avoid grapefruit juice, as it can increase the risk of side effects.
  • A high-fat meal may delay onset of action.

Effectiveness

Sildenafil has been shown to be effective in up to 80% of men with ED, with effects typically noticeable within 30 to 60 minutes, and lasting for up to 4–5 hours.

Side Effects

Common side effects include:

  • Headache
  • Flushing
  • Nasal congestion
  • Indigestion

Less common but serious effects include visual disturbances, hearing changes, or prolonged erections. Seek medical attention if severe or persistent side effects occur.

Contraindications

Sildenafil should not be used by those:

  • Taking nitrates for chest pain
  • With severe heart or liver conditions
  • Under 18 years of age
  • With certain medication interactions (e.g. alpha-blockers, antifungals, antibiotics)

Interactions

Inform your doctor of all medications and supplements before use. Interactions may occur with:

  • Nitrates
  • Alpha-blockers
  • Some antibiotics and antifungal medicines

Alcohol and Heart Conditions

Avoid excessive alcohol while taking sildenafil, as it can lower blood pressure and increase side effect risk. Use with caution if you have any heart-related conditions.

Availability and Cost

Sildenafil is available by prescription only in the UK.

  • Generic versions are more affordable than branded Viagra.
  • Supplied by licensed UK pharmacies such as Online Chemist.
  • Avoid counterfeit products from unregulated websites.

Take Control of Your Sex Life

Don’t let ED affect your confidence or relationships. Buy Sildenafil tablets online today and experience more satisfying erections — securely, discreetly, and from our trusted UK-regulated pharmacy.

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Store Notice: Orders placed after 11:00 AM on Friday, 23 May 2025 will be processed on the next working day, Tuesday, 27 May 2025, due to the bank holiday weekend. Thank you for your understanding.

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