Medically reviewed by: Thomas Fischer (Pharmacist). This article has been written according to strict guidelines and medical standards.
Medically reviewed by: Thomas Fischer (Pharmacist)
Cialis is a prescription brand name drug meant for patients with erectile dysfunction (ED), benign prostatic hyperplasia (BPH), or both. The active ingredient is tadalafil, which comes from a family of drugs, considered PDE5 inhibitors. It’s available in 2.5, 5, 10, and 20 mg doses. The right dose for each patient differs.
Patients who have erectile dysfunction can use Cialis to assist with relaxing the blood vessels in and around the penis. This facilitates the circulation of blood in the region. Some consider it a nuisance, at times, because it can cause erections that last much longer than anticipated. Those with BPH can use the drug to relax muscles that control the bladder, making it easier to urinate.
While Cialis is fantastic and has been a great option in the past, its patent expired. This has propelled its active ingredient, tadalafil, into the generic market. There’s plenty to look into and consider surrounding this event. This situation has impacted the prices, popularity, and use of the active ingredient around the world.
Why Would the Cialis Patent Expire?
Tadalafil, and subsequently Cialis, was discovered in 1991 by GlaxoSmithKline. Seven years later, Lilly started manufacturing the drug. This led to a great alternative to Viagra for ED. The main draw for this drug is its 17-hour half-life. So, instead of a small period of 4 hours where a patient can enjoy a healthy or enhanced erection, Cialis helps men achieve an erection at any time within 36 hours.
Patents for medication run out after a certain amount of time, or when a company fails to issue a new one. Typically, these last for 20 years. Interestingly enough, some expire in different parts of the world before others. So, you might find generic versions of medication in the UK, while only brand versions exist in the US.
There are ways to extend the original. For example, Pfizer was able to patent Viagra. When this was set to expire, they filed additional applications and furthered the initial one for many more years. The case for Cialis, however, is different.
Cialis, whose active ingredient is tadalafil, was patented during its approval process. This can take quite a long time. If an approval process takes five years, and a patent is issued a year into it, then the license upon release will last 16 years.
Did you know?
When is the Cialis Patent Set to Expire?
The Cialis patent isn’t set to expire, because it already has. Lilly lost its exclusivity to sell tadalafil in the UK in 2017. Other companies quickly jumped in to start producing generic alternatives.
As mentioned, this was because the patent expired after 20 years, and Lilly failed to renew or file additional patents. An early patent filing caused part of this during the approval process.
In the US, the patent expired in September of 2018. The situation was supposed to be different, however. The idea was a final date somewhere in April of 2020. But, because of disputes over the packaging and administration of tadalafil, the expiration was set back by two years. This two-year difference was meant to guarantee exclusivity. Lilly made the following statement: “This is a royalty-bearing license agreement that provides us with more certainty regarding our US exclusivity.”
While they were successful with their attempt, this shortened the patent and pushed the active ingredient into the open market. The result involved many labs jumping in to start producing generic alternatives.
Generic Alternatives - Viable Option After Cialis Patent Expiration?
As soon as the patent for tadalafil expired, the flood gates for generic alternatives flew open. The previous prices for the drug presented as brand-name Cialis hovered around $2000 for a box of 30 tablets. The free market did what it does best: allow competition. The end result was a more affordable alternative for customers and patients.
Generic alternatives are presented and sold for less than half of what Cialis is worth. This price drop makes tadalafil available to more people around the world. So, you might consider it a viable option after the Cialis patent expiration. However, because of its availability, it’s important to keep in mind that you should only use the drug after seeing a doctor. There are many side effects that might apply if you’re an individual with a high-risk status.
- Generic Cialis Without A Prescription – Risks To Consider
- Ordering Tadalafil Without A Prescription – Risks To Consider
- How to Buy Generic Tadalafil Online In The USA
- How To Order Generic Cialis Safely Online
- Buying Tadalafil from a Canadian Pharmacy – What Risks Are Involved?
- Ordering Tadalafil from India – Is This Legal?
- Paying Generic Cialis With PayPal: Is This Possible?
Is it Risky to Buy Cialis Without Patent Protection - Counterfeits and More
Many consider patent protection as a sort of stamp that guarantees the safety and regulation of a drug. However, a patent is only meant to protect the rights that a person, or company, holds on a product over a certain period of time. While it might add some validity and authority to a product, it has no direct correlation with how legitimate a product or service is.
Buying Cialis nowadays is no different. While the company no longer holds a strict patent on the drug, it’s still regulated and only sold under approval of each country’s government authorization. If it’s allowed in your region, it’s most likely safe. However, counterfeits are still an issue. The only way to avoid impersonations of certain drugs is to buy them from properly licensed and regulated pharmacies.
So, while patent protection has little influence on the safety or concern one might have over a drug, it’s still essential to check the legitimacy of the seller and where it’s produced. If you’re buying in the US, however, and you are vigilant with your pharmacy choice, it’s very unlikely you’ll stumble across counterfeit versions. All the same, you should always double-check.
Our tip: How to buy Cialis with online prescription
Can Generic Cialis Have a Patent?
Generic Cialis, or tadalafil, can’t have a patent. This would negate the entire objective set by the scheme. These are meant to protect the rights that a person or company has over the product or service, thus making it impossible for a generic alternative to hold this type of protection.
In fact, generic options are meant to provide a choice for consumers. So, patients can opt for a cheaper or more accessible version of the drug instead of purchasing a brand-name medication. If it has a patent, then it isn’t a generic version, it’s actually the brand-name until the license runs its course.
Sexual Enhancers Without a Patent - What to Watch Out For
There are a few things to consider if you’re interested in buying sexual enhancers in the US. First of all, mainstream medication, like Viagra and Cialis, have active ingredients that are trusted and hold a well-known rate of efficacy. While these two companies no longer hold the patents for their respective active ingredients, there are some alternatives that you should watch out for.
Some drugs without a patent can cause you harm. In fact, the FDA has warned consumers in the past regarding these alternatives. Their primary focus is on dietary supplements. Many of these claim to enhance sexual performance, improve weight loss, or multiply efforts in bodybuilding.
While these dietary supplements, and the active ingredients they contain, don’t hold a patent, they’re considered dangerous for other reasons. First of all, they don’t require a prescription. Thus, they aren’t regulated or observed consistently by medical personnel or investigators. This lets the companies that produce these drugs to run wild with claims, all in the name of marketing and boosting sales.
Before buying sexual enhancers that don’t hold a patent, you should check for other, more important, indicators of the validity a drug might have. You can consult online indexes for approved and regulated medication that’s available over-the-counter.
First and foremost, always consult a doctor before following through with treatment. Erectile dysfunction, or other afflictions that damage sexual performance, can lead to dangerous situations when treated without a consultation. Self-dosing without medical advice could be deadly. Side effects, interactions, and contraindications need to be fully understood before using any form of medication.
Article Sources
- Questions and Answers for Cialis (tadalafil). In: U.S. Food and Drug Administration. URL: https://www.fda.gov/
- Parker-Pope, Tara (August 28, 2009). “The Cost of Treating Erectile Dysfunction“. New York Times.
- CIALIS- tadalafil tablet, film coated. Eli Lilly and Company. URL: https://uspl.lilly.com/
- Mallor, Jane. BUSINESS LAW: THE ETHICAL, GLOBAL, AND E-COMMERCE ENVIRONMENT (15th ed.). McGraw-Hill/Irwin. p. 266.
- Heller, Michael; Eisenberg, Sue (May 1, 1998). “Can Patents Deter Innovation? The Anticommons in Biomedical Research“. Science. 280 (5364): 698–701.
- “Patents: Frequently Asked Questions”. In: World Intellectual Property Organization. Archived from the original on 20 June 2015. Retrieved 15 July 2020.