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Archived from the original on 12 October 2020. ^ "Viagra 25mg film-coated tablets Summary of Product Characteristics (SmPC)".

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In 2026 a chocolate syrup called Boner Bears from Lockout Supplements was recalled through the FDA because of it containing Sildenafil as an undisclosed ingredient. Counterfeit Viagra, despite generally being cheaper,[88] can contain harmful substances or substances that affect how Viagra works, such as blue printer ink, amphetamines, metronidazole, boric acid, and rat poison. Viagra is one of the world's most counterfeited medicines. [90][91] According to a 2012 Pfizer study, around 80% of sites claiming to sell Viagra were selling counterfeits. An October 2023 release stated that erectile dysfunction medicines were the most seized drugs by the Interpol[92] accounting for 22% of seizures.

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In 1992, Pfizer filed a patent covering the substance sildenafil and its use to treat cardiovascular diseases. [96] This would be marketed as Revatio. The patent was published in 1993 and expired in 2012. The patent on Revatio (indicated for pulmonary arterial hypertension rather than erectile dysfunction) expired in late 2012. Generic versions of this low-dose form of sildenafil have been available in the US from a number of manufacturers, including Greenstone, Mylan, and Watson, since early 2013. ^ "Viagra Connect 50 mg film-coated tablets Summary of Product Characteristics (SmPC)". Archived from the original on 13 August 2020.

Archived from the original on 11 October 2020. Archived from the original on 11 November 2020.

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Sales of PalPal by Hanmi Pharmaceuticals totalled ₩22 billion or about 86% the market sildenafil citrate tablets 150 mg share of Viagra that year. [125] By 2017, there were over 50 generic sildenafil pills available. During that year Viagra sales slumped to 38% that of Palpal. There were 2,958,199 prescriptions for Sildenafil in 2016 in England, compared with 1,042,431 in 2006. In 2018, Viagra Connect, a particular formulation of Sildenafil marketed by Pfizer, became available for sale without a prescription in the UK. ^ Nichols DJ, Muirhead GJ, Harness JA (6 March 2002).

"Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality".

• Sildenafil OTC refers to over-the-counter availability of the medication.
• It is used primarily to treat erectile dysfunction in men.
• Sildenafil works by increasing blood flow to the penis.
• OTC status varies by country; in many, it's prescription-only.
• Common side effects include headaches, flushing, and nasal congestion.
• It should be used with caution in individuals with heart conditions.
• Interactions may occur with nitrates and certain blood pressure medications.
• Dosage and timing are important for effectiveness and safety.
• Buying sildenafil OTC without consultation can pose health risks.
• Fake or counterfeit sildenafil is common in unregulated markets.
• Always check for proper labeling and original packaging.

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[97] Health care providers may prescribe generic sildenafil for erectile dysfunction. [98] For a time, the generic was not available in the same dosages as branded Viagra, so using dosages typically required for treating ED required patients to take multiple pills. In 1994, Pfizer filed a patent covering the use of sildenafil to treat erectile dysfunction. [99] This would be marketed as Viagra. This patent was published in 2002 sildenafil tablets 125 and expired in 2019.

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Teva sued to have the latter patent invalidated, but Pfizer prevailed in an August 2011 federal district court case. [100] An agreement with Pfizer allowed Teva to begin to provide the generic drug in December 2017. In the United States, Pfizer received two patents for sildenafil: one for its indication to treat cardiovascular disease (marketed as Revatio) and another for its indication to treat erectile dysfunction (marketed as Viagra). The substance is the same under both brand names. Sildenafil is available as a generic drug in the United States, labeled for pulmonary arterial hypertension,[98] and to treat erectile dysfunction, as the patent expired in April 2020. Archived from the original on 23 April 2020. PDE-5 inhibitors appear to have significant but moderate efficacy in secondary [Raynaud's phenomenon].

• Sildenafil enhances nitric oxide activity in blood vessels.
• OTC products may be less potent or have different formulations.
• Always follow the recommended storage instructions.
• Some OTC products claim to be " Viagra alternative."
• Use in conjunction with a healthy lifestyle improves outcomes.
• OTC sildenafil isn't a substitute for medical diagnosis.
• Regular check-ups are advised if using sildenafil long-term.
• Always verify whether OTC sale is legal locally.
• Reports of adverse reactions should be documented and shared.
• Keep detailed records of doses and side effects.
• Education about risks and benefits helps safe use of OTC sildenafil.

"Sublingual sildenafil in the treatment of erectile dysfunction: faster onset of action with less dose". "The Serendipitous Story of Sildenafil: An Unexpected Oral Therapy for Erectile Dysfunction". ^ "Drug Approval Package: Viagra (sildenafil citrate) NDA #020895". U.S. Food and Drug Administration (FDA). Archived from the original on 31 March 2021. Archived from the original on 12 August 2025.

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[114] Finally, on 22 April 2013, the Supreme Court of Canada invalidated Pfizer's patent altogether. Manufacture and sale of sildenafil citrate drugs is common in China, where Pfizer's patent claim is not widely enforced. Egypt approved Viagra for sale in 2002, but soon afterwards allowed local companies to produce generic versions of the drug, citing the interests of poor people who would not be able to afford Pfizer's price. In June 2013 Pfizer's patent on sildenafil citrate expired in some member countries of the European Union, including Austria, Denmark, France, Germany, Ireland, Italy, The Netherlands, Spain, Sweden, the United Kingdom, and Switzerland. [117][118][119] A UK patent held by Pfizer on the use of PDE5 inhibitors (see below) as treatment of impotence was invalidated in 2000 because of obviousness; this decision was upheld on appeal in 2002.

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Manufacture and sale of sildenafil citrate drugs known as "generic Viagra" is common in India, where Pfizer's patent claim does not apply. Brand names include Kamagra (Ajanta Pharma), Silagra (Cipla), Edegra (Sun Pharmaceutical), Penegra (Zydus Cadila), Manly (Cooper Pharma) and Zenegra (Alkem Laboratories). Sildenafil was reclassified in New Zealand in 2014 so it could be bought over the counter from a pharmacist. It is thought that this reduced sales over the Internet and was safer as males could be referred for medical advice if appropriate. In 1999 South Korea granted two patents to Pfizer related to sildenafil. ^ "Sildenafil Drug Usage Statistics, United States, 2014 - 2023". "Generic Viagra: Two versions of sildenafil hit the market today". Archived from the original on 25 November 2018.

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In February 2007, it was announced that Boots, the UK pharmacy chain, would try over-the-counter sales of Viagra in stores in Manchester, England. Males between the ages of 30 and 65 would be eligible to buy four tablets after a consultation with a pharmacist. [75] In 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) enacted legislation that expanded this nationwide,[76] allowing a particular branded formulation of Sildenafil, Viagra Connect (50 mg), to be sold over the counter and without a prescription throughout the UK from early 2018. While the sale remains subject to a consultation with a pharmacist, the other restrictions from the trial have been removed, allowing customers over the age of 18 to purchase an unlimited number of pills. In May 2013, Pfizer, which manufactures Viagra, told the Associated Press they will begin selling the drug directly to people on its website.

3) Eat a healthy diet

Pfizer's patents on Viagra expired outside the US in 2012; in the US they were set to expire, but Pfizer settled litigation with each of Mylan and Teva which agreed that both companies could introduce generics in the US in December 2017. [79][80] In December 2017, Pfizer released its own generic version of Viagra. As of 2018[update], the US Food and Drug Administration has approved fifteen drug manufacturers to market generic sildenafil in the United States. Seven of these companies are based in India. The patent for Pfizer's Viagra sildenafil to treat erectile dysfunction expired in April 2020. Archived from the original on 12 February 2022.

"With Viagra Now Available Over-The-Counter In The U.K., Will The U.S. "Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus".

"Strategies for managing sexual dysfunction induced by antidepressant medication".

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The first document guaranteed sole production and sale of the substance until 2012, while the second gave Pfizer the exclusive use to treating erectile dysfunction with sildenafil until 2014. [123] In 2011 Hanmi Pharmaceutical and CJ CheilJedang launched a suit against the exclusive use patent. The Korean Court system made a ruling against Pfizer in June 2012, allowing for the unhindered domestic production of generic prescription sildenafil. In 2012, Viagra lost its position as the top selling erectile dysfunction treatment in South Korea. This development was credited largely "due to the introduction of generic products." Generic sildenafil became publicly available in May. The Cochrane Database of Systematic Reviews (5) CD003382. Archived from the original on 10 October 2020. "Efficacy and safety of sildenafil treatment in pulmonary arterial hypertension: a systematic review".

• The FDA strictly regulates sildenafil prescription sales in the USA.
• Some countries have recent legislation allowing OTC sales in pharmacies.
• Side effects can include prolonged erections needing medical attention.
• OTC sildenafil is often part of "sex enhancement" supplements.
• Natural alternatives to sildenafil include lifestyle changes and herbal remedies.
• Lack of clinical testing in OTC products increases risks.
• Always read the label for dosage and contraindications.
• OTC sildenafil should not replace professional medical advice.
• Adverse effects may be more severe in older adults.
• Some OTC products contain undisclosed prescription drug ingredients.
• Responsible use minimizes health risks associated with sildenafil.

Archived from the original on 29 August 2021.

Overdose/Missed Dose

In the US, Revatio and Viagra are marketed by Viatris after Upjohn was spun off from Pfizer. In Canada, Pfizer's patent 2,324,324 for Revatio (sildenafil used to treat pulmonary hypertension) was found invalid by the Federal Court in June 2010, on an application by Ratiopharm Inc.[106][107] On 8 November 2012, the Supreme Court of Canada ruled that Pfizer's patent 2,163,446 on Viagra was invalid from the beginning because the company did not provide full disclosure in its application. The decision, Teva Canada Ltd. v. Pfizer Canada Inc., pointed to section 27(3)(b) of The Patent Act which requires that disclosure must include sufficient information "to enable any person skilled in the art or science to which it pertains" to produce it.

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It added further: "As a matter of policy and sound statutory interpretation, patentees cannot be allowed to 'game' the system in this way. This, in my view, is the key issue in this appeal. Teva Canada launched Novo-Sildenafil, a generic version of Viagra, on the day the Supreme Court of Canada released its decision. [109][110][111] To remain competitive, Pfizer then reduced the price of Viagra in Canada. [112] However, on 9 November 2012, Pfizer filed a motion for a re-hearing of the appeal in the Supreme Court of Canada,[113] on the grounds that the court accidentally exceeded its jurisdiction by voiding the patent. "Raynaud's phenomenon and digital ischaemia--pharmacologic approach and alternative treatment options".

• Speed of effect varies depending on individual health and food intake.
• OTC sildenafil is often marketed with emphasis on privacy.
• Remember that natural or herbal products are not always safe.
• Be aware of side effects like vision flickering or color changes.
• Always consult a healthcare provider if you experience adverse effects.
• OTC sildenafil does not treat underlying health conditions.
• Cost varies significantly between brands and sources.
• Use only FDA-approved or certified OTC products.
• OTC sildenafil should not be combined with other ED medications.
• Watch for counterfeit products in online marketplaces.
• Proper consultation can prevent potential drug interactions.

"Efficacy of Sildenafil on healthy humans in high‑altitude hypoxia at rest and during exercise: A meta‑analysis". "Interventions for preventing high altitude illness: Part 1.