Why Generic Levitra Is Now Available
What is a generic drug?
A generic drug is a pharmaceutical drug that has the same active ingredient as that that was originally developed and patented by the pharmaceutical company that first discovered and/or developed the drug.
When a pharmaceutical drug is first patented, it is usually marketed under a brand name. In most cases, a drug patent lasts for about twenty years. However, as pharmaceutical companies tend to apply for patents even before a drug has undergone adequate clinical trials, the actual duration of the patent is likely to be much less than that.
The benefit of having a drug patent is that only that pharmaceutical company can market and sell the patented drug for the duration of the patent. This gives the pharmaceutical company enough time to recoup its costs of manufacturing the drug.
Generic drugs can be manufactured and sold by other pharmaceutical companies after the expiration date of the patent given to the pharmaceutical company that first developed the drug.
For generic drugs to be authorised in most countries, including the UK, they must be identical to the branded drug in terms of their efficacy, safety, usage, route of drug administration, pharmacokinetics and pharmacodynamics. Thus, generic drugs can be interchanged with the branded versions.
However, on some rare occasions, the branded version is not interchangeable with the generic version. Where this happens, in the UK, the MHRA (Medicines and Healthcare products Regulatory Agency) requires the generic medicines to have a brand name of their own so that patients may be maintained on a single manufacturer’s product.
Once an original branded drug loses its patent protection, generic equivalents of the branded drug are launched, typically by many manufacturers. The competition between these manufacturers drives down prices, often leading to a price reduction of up to 90% or more within a few weeks of the patent expiration.
The benefit of this is that generic medicines make the drugs bill affordable and promote innovation.
To summarise, a drug can be manufactured as a generic drug when any of the following apply:
- The drug’s patent has expired
- The company that would manufacture the generic drug certifies that the patents held on the drug are either unenforceable, are invalid or would not be infringed upon
- There have never been any patents on the drug before
- The generic drug is to be manufactured in a country or countries where the drug has no patent protection
What is Levitra?
Levitra is the brand name of a medication called Vardenafil (Hydrochloride) and is manufactured by Bayer Plc. Levitra is available as 5mg, 10mg and 20mg film-coated tablets and 10mg orodispersible tablets.
It belongs to the pharmacotherapeutic group known as Urologicals and is indicated for the treatment of erectile dysfunction in adult men. It is not indicated for use by women. With sexual stimulation, Levitra works to restore impaired erectile function by increasing blood flow to the penis.
The active ingredient, Vardenafil, is a potent and selective inhibitor of the cGMP (cyclic guanosine monophosphate) specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum. Vardenafil potently enhances the effect of endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5. When nitric oxide is released in response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum levels of cGMP. Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.
As the film-coated tablets, Vardenafil is rapidly absorbed and its maximum observed concentrations in the plasma are reached in some men as early as 15 minutes after oral administration. However, 90% of the time, the maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing when taken on an empty stomach.
That said, when Vardenafil film-coated tablets are taken with a mean with a high-fat content (containing at least 57% fat), the rate of absorption of Vardenafil is reduced. This consequently leads to an increase in the median time taken to be effective to 1 hour and a mean reduction in maximum plasma concentration of 20%.
Vardenafil is rapidly absorbed after administration of Vardenafil 10 mg orodispersible tablets without water. The median time to reach its maximum plasma concentration varied between 45 to 90 minutes after administration.
After the tablets have been taken orally, Vardenafil is excreted as metabolites predominantly in the faeces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose).
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What do Levitra tablets look like?
- Levitra 5 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “5” on the other side.
- Levitra 10 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “10” on the other side.
- Levitra 20 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “20” on the other side.
- Levitra 10mg Orodispersible tablets: White round tablets.
It is important to note that Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10 mg film-coated tablet and cannot be used interchangeably.
List of excipients of Levitra film-coated tablets
Tablet core:
- Crospovidone.
- Magnesium stearate.
- Microcrystalline cellulose.
- Silica, colloidal anhydrous.
Film coat:
- Macrogol 400.
- Hypromellose.
- Titanium dioxide (E171)
- Ferric oxide yellow (E172)
- Ferric oxide red (E172)
List of excipients of Levitra Orodispersible tablets
Tablet core:
- Crospovidone.
- Magnesium stearate.
- Microcrystalline cellulose.
- Silica, colloidal anhydrous.
Film coat:
- Macrogol 400.
- Hypromellose.
- Titanium dioxide (E171)
- Ferric oxide yellow (E172)
- Ferric oxide red (E172)
Anyone is who is allergic and/or hypersensitive to Vardenafil or any of the excipients is not to take Levitra.
Why is generic Levitra now available?
It is not uncommon for a drug to have several patents that covers several things including the active ingredient and the delivery mechanism. Thus, any one drug can have several patents that protect different aspects of its formulation and/or the final product. If the patent application for the different aspects were submitted at different times, it is possible that all the patents for that one drug, in particular, could be years apart.
This makes pinpointing the exact expiration date of a patent, not the easiest thing to do.
That said, it is expected that Bayer Plc’s patent for Levitra is set to expire on the 31st of October 2018.
This means that other pharmaceutical companies can sell the generic version of Levitra under the name Vardenafil (Hydrochloride) and at a lower price.
Whether the medicine is marketed as Levitra or Vardenafil, they work in the same way to treat the same condition and should be just as effective as each other.
The pharmaceutical company TEVA has received tentative approval for it to manufactured its own generic version of Levitra as Vardenafil.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important as it allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and members of the public are encouraged to report any suspected adverse reactions via the Yellow Card Scheme.
You can find out more about the Yellow Card Scheme on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
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References
- https://www.news-medical.net/health/Drug-Patents-and-Generics.aspx
- http://www.britishgenerics.co.uk/about-generics
- https://www.nhs.uk/conditions/medicines-information/
- https://www.medicines.org.uk/emc/search?q=levitra
- http://www.bayer.co.uk/en/businesses/pharmaceuticals/specialty-medicine-general-medicine/our-products/
- https://bnf.nice.org.uk/drug/vardenafil.html#indicationsAndDoses
- https://medcitynews.com/2018/01/drug-patents-expire-2018/?rf=1
- https://yellowcard.mhra.gov.uk/
- https://medcitynews.com/2018/01/drug-patents-expire-2018/?rf=1
- https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=021400&Appl_type=N
- https://markets.businessinsider.com/news/stocks/some-branded-drugs-going-generic-in-2018-1013567302
- https://www.drugs.com/availability/generic-levitra.html
- https://www.medicines.org.uk/emc/product/7628/smpc
- https://www.medicines.org.uk/emc/product/7629#EXCIPIENTS
Mens Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].