What Is The Difference Between Tadalafil And Cialis®?

You may have previously received a prescription for Cialis® from your doctor for your erectile dysfunction (impotence) and noticed that your new prescription says Tadalafil. Perhaps your prescription has always been for Tadalafil, but when you collected your medicine from the pharmacy the name on the packaging of your medicine was Cialis®. However, now the label on the box of tablets says Tadalafil. Or, maybe, your tablets look different from the ones you collected last time from the pharmacy – they are a different colour and/or shape. You may, therefore, be wondering if they are the same thing or if someone has made a mistake and given you a different medicine.

The answer is no, most likely there is no mistake. In this article, we will look at why your medicine appears to have changed names and why your medicine may look different.

 

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Why has the name of my medicine changed?

Some medicines will have only one name, but most medicines are known by several names. All medicines will have at least one common or official generic name, which usually describes the chemical composition of the active drug, or if the chemical name is complicated, a simpler name. The simpler name may be a shorter form of the chemical name or may be related to the way it works. The generic name, also known as the non-proprietary name, will be used to describe the medicine wherever in the world it is used. You can imagine the confusion if every country decided to call the same medicine by a different name! The World Health Organization (WHO) is responsible for managing the international non-proprietary names (INN) system.1

prescription-webHowever, that said, there are some national medicine naming schemes, which differ from the INN scheme meaning that some medicines can have more than one generic name, though this is rare. For example, the common painkiller known by the generic name paracetamol in the United Kingdom (UK), is known by the generic name acetaminophen in the United States of America (USA).1 Both are shortened versions of the chemical name, i.e. para-acetylaminophenol and para-acetylaminophenol.

Apart from the generic name, a medicine may be known by a unique brand name given to it by the drug company that first developed the product. The branded medicine will be protected by patent and the name cannot be used by another drug company to describe their medicine with the same active generic ingredient. The patent will protect, not just the chemical composition and form (e.g. tablet, liquid, inhaler, etc.) of the medicine, but also amongst other things, the shape and colour of the medicine. Later in the article, we will discuss in greater detail the relationship and differences between branded and generic medicines.

But, just to muddy the waters, a drug company may give their medicine a different brand name in different parts of the world. There are several reasons why this may be necessary. For example, there may be a different medicine in one country with the same or similar-sounding name. So, the authorities in that country may decide it should have a different name to avoid doctors prescribing or pharmacists dispensing the wrong medicine, or healthcare workers or carers giving the wrong medicine, or even the patient themselves mistaking it for another medicine. Another reason could be that the name of the medicine has an undesirable meaning in another language.

That is not all! Just to confuse matters further, some drug companies may choose to give their generic medicine a brand name. This is what is called a branded generic medicine. In addition, the company that produced the original branded medicine may also decide to produce a generic version of their own brand medicine.

So, although the medicine you have received has a different name and/or looks different from what you are used to, the active ingredient it contains is the same. However, while there can only be one medicine with a particular brand name, there can be several different generic versions of the medicine.

Confused? Let’s take a closer look using the specific example of the medicines used to treat erectile dysfunction, of which Cialis® is one.

 

Where does Cialis® fit in with other medicines for erectile dysfunction?

Viagra®, also known by the generic name Sildenafil, was the first oral medicine available to treat erectile dysfunction. The medicine, first available in the UK in September 1998, was, not surprisingly, hugely popular. With the overwhelming success of Viagra®, the race was on to develop similar medicines. Other drug companies scrambled to get on the bandwagon in an effort to make the most of a potentially huge market, by producing their own brand.

To date, five oral medicines in the same chemical class as Viagra® have been developed for treating erectile dysfunction. While these medicines have a similar structure and work in a similar way to Viagra®, they are different enough that they can, therefore, have their own generic names and are also given different brand names by the companies that developed them. One of these medicines is Cialis® (brand name) or Tadalafil (generic name).

 

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Cialis & Tadalafil (As Needed)

£16.98£260.00

Cialis works in a similar way to Viagra and is quicker acting and lasts longer. It can be taken when needed, 30 minutes before intercourse.

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Product Description

About Cialis

At least one in ten men has trouble getting an erection at some time. Cialis helps men to get and maintain an erection when sexually stimulated and/or excited. The medicine relaxes the blood vessels in the penis which results in more blood flowing to the penis. It reduces the action of the natural chemical in your body that makes erections go away.

How to take it?

You should take Cialis at least 30 minutes before intercourse. Cialis remains effective for 36 hours, meaning it will be easier to keep and maintain an erection when you are sexually excited. It doesn’t matter if you take this medicine with or without food; food has no impact on its effectiveness.

This medicine will only work when you’re sexually excited. You won’t get an erection just by taking Cialis.

What dose should I take?

The recommended starting dose for Cialis is 10mg tablets. If this dose is not effective you can try 20mg tablets. A maximum of one tablet should be taken in 24 hours, however it’s not recommended to take either the 10mg or 20mg tablet every day.

For patients who anticipate sexual activity at least twice weekly, the 5mg “daily” Cialis dose is more appropriate.

Patient Information Leaflet

Always read the patient information leaflet before commencing treatment. The Patient Information leaflets can be found here for 10mg and 20mg dosages.

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Why did these companies not just produce a generic version of Viagra®?

Let us take a step back here and discuss how generic medicines become available. Developing a new medicine involves a massive investment of time and money. Drug companies must carry out research on the chemical compound, as well as clinical studies to make sure the medicine works effectively and will not harm patients. This can take 10 to 12 years from the first stages to the time it takes to get approval from the bodies that licence medicines (e.g. the Food and Drug Administration’s (FDA) in the US or the European Medicines Authority in Europe) and to get to market. In addition, the company will invest in advertising, marketing, and promoting their medicine. The cost of this process has been estimated to be approximately $2.6 billion.

Because of this, drug companies are allowed several years after the medicine is available on the market to recover their investment. How does this work? When they register their medicine (which may be years before the medicine comes to market), the licencing body will not allow any other company to make and market the same medicine for the same disease or condition during a specified period. This can vary from 10 to 15 years, and up to 20 years in the USA. This process is called patent protection. It is not unusual for a company to licence their medicine in many different countries so that they can benefit as much as possible from their investment.Tadalafil_8TAB 20MG

However, once this period has passed (i.e. the patent has expired) other companies can make the same medicine, with the same active ingredient and market it for the same disease or condition, without having had to invest similar amounts of time or money.

So, to answer the question, companies were prevented from producing a generic version because Viagra® was protected by patent. What they could do instead, was invest in researching and producing a medicine similar, but different, in chemical composition, to Viagra®.

Because these medicines were sufficiently different from Viagra® in composition, they were considered new medicines and not generic medicines. Therefore, the companies could register their own patents for these new medicines and enjoy the same protection from competition to allow them to profit from their investment.

 

What does it take to get a generic medicine approved?

In order to get their generic medicine approved by the licensing body, the manufacturer must show the licensing body that their version works just as well as the branded medicine and that any side effects are similar to and no worse than the original medicine. It must have the same active ingredient, be the same strength, be used for the same condition, have the same effect and be the same form. They must also show that it reaches the same concentration in the body and to the same extent. In addition, they must show that they have tested it to the same standards applied to the original branded medicine.

 

How are generic medicines different from branded medicines?

Because brand medicines are protected by patent, generic medicines cannot look exactly like the branded version. So, they will differ in appearance. They may be a different shape or colour and the inactive ingredients, such as flavouring and preservatives, may also differ. The packaging will also be different. However, any differences will not affect how well the generic medicines work or its safety.

 

Why are generic medicines so much cheaper than branded medicines?

It is worth noting that some companies prefer not to invest in researching new chemical products as potential medicines. They prefer to wait until the patent expiry of branded medicines and then produce generic versions. As they have not had to invest the years of research and development, and marketing expenses needed to bring a new medicine to market, these companies can take advantage of an established market and sell their medicines at a cheaper price.

 

What do I need to know about branded Cialis® tablets and generic Tadalafil tablets?

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Cialis® (generic name Tadalafil) became available on the UK market in November 2002 and was protected by patent. However, as the patent on Cialis® is due to expire in 2017, other companies will be allowed to produce and market generic versions of Tadalafil. However, they cannot use the name Cialis® to describe their tablets. Some will choose to just market it under the generic name, but some may choose to give their product a brand name (i.e. a branded generic), as we discussed above.

Doctors in the UK are encouraged to prescribe medicines using the generic name, whenever possible and appropriate. Using the generic name means that all doctors and other healthcare professionals are using the same names when talking about medicines. This helps to avoid possible confusion or reduce mistakes that may happen from using different brand names.

However, there are a few medicines that doctors are encouraged to prescribe by brand name. These medicines need be within a very narrow concentration range in your body (you may hear drug concentration in the body referred to as bioavailability). Outside of this concentration range, they may be ineffective or cause side effects. Because there can be some allowable differences in drug concentrations between a branded and a generic medicine (discussed further below), this may cause problems if you switch between different brands or versions of the same generic medicine, as the amount of drug in your body could fall outside of this range. Cialis® is not one of these medicines.

 

Are Cialis® and Tadalafil equally effective?

As we have discussed above, for a generic medicine to be licensed the manufacturer must show that it contains the same active ingredient and works in the same way as the original branded medicine. Therefore, you can be assured that Cialis® and generic Tadalafil will be equally effective. However, there are some points worth noting about the information manufacturers must submit to get their generic medicine licensed, and about how medicines work in the body.

First, let’s start with the evidence manufacturers must submit. To prove that their medicine is equivalent to the branded medicine, manufacturers are required to show that the concentration of the active ingredient in the body after a person takes their medicine is no less than 80% and no more than 125% of what you get when a person takes the branded medicine. So, a tablet of Tadalafil, which is labelled as containing 10 mg of the active ingredient may actually contain a dose between 8 mg and 12.5 mg.

Next, bear in mind that individuals differ in the way that they respond to a medicine. So, one person may respond better to a particular concentration of a medicine than another person. Therefore, when you consider the fact that different generic medicines may have a range of concentrations of the active ingredient, it is possible that you may respond differently to one version than to another or to the branded version. However, for most people, these differences will not matter, as they will get the desired response to the medication within that range of concentrations. It is only for medicines where a narrow concentration range is critical, as discussed above, where this will be important. And we have established that Cialis® is not one of those medicines.

 

In conclusion…

I hope that you are now feeling better informed and understand the difference between Cialis® and Tadalafil. To recap, Cialis® is the brand name given by the manufacturer to their version of tablets used to treat erectile dysfunction and that contain the active ingredient known by the generic name Tadalafil.

The Cialis® brand of Tadalafil has a unique combination of characteristics, i.e. shape, colour, non-active ingredients, etc. that are protected by a patent. This patent is due to expire in 2017, after which time other drug companies will be allowed to make their own version of tablets containing the generic active ingredient Tadalafil. Generic Tadalafil tablets will most likely look different from the Cialis® branded tablets. They may be a different colour or shape and may contain different types of non-active ingredients.

Whichever version of Tadalafil tablets you receive, it will have been thoroughly tested before being approved by the licensing body as suitable to be used to treat erectile dysfunction. Whether you receive the generic version of Tadalafil or the original branded version, Cialis®, the tablets will work in the same way and have a similar effect on most people.

 

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References

  1. International Nonproprietary Names. com. https://www.drugs.com/inn.html. Accessed 21 November 2017.
  2. Pfizer Ltd. Viagra® (sildenafil). Summary of product characteristics. June 2016. https://www.medicines.org.uk/emc/medicine/1474. Accessed 20 November 2017.
  3. The high cost of inventing new drugs — and of not inventing them. Forbes: From Hope to Cures, News. // April 11, 2015. http://www.fromhopetocures.org/the-high-cost-of-inventing-new-drugs-and-of-not-inventing-them.
  4. Tufts Center For The Study Of Drug Development. Cost to develop and win marketing approval for a new drug is $2.6 billion. News. November 18, 2014. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study.
  5. US Food and Drugs Administration. Frequently Asked Questions on Patents and Exclusivity. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm#howlongpatentterm. Accessed 21 November 2017.
  6. US Food and Drugs Administration. Generic Drug Facts. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm167991.htm.
  7. Stoppler M. Generic drugs, are they as good as brand-names? com. https://www.medicinenet.com/script/main/art.asp?articlekey=46204. Accessed 21 November 2017.
  8. Eli Lilly and Company Limited. Cialis® (tadalafil). Summary of product characteristics. April 2017. http://www.medicines.org.uk/emc/medicine/11363/SPC/Cialis+2.5mg,+5mg,+10mg+&+20mg+film-coated+tablets. Accessed 21 November 2017.
  9. Gever J, Fiore K, Neale T. Generics versus brands: are they really equivalent? Medpage Today. August 25, 2009. https://www.medpagetoday.com/productalert/prescriptions/15685. Accessed 21 November 2017.

 

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