Patient Information Leaflet Always read the patient information leaflet before commencing treatment. Patient information can be found here. A generic medicine contains the same active medicinal substance as an originator pharmaceutical product. Because it acts in the same way in the human body, it is interchangeable with the originator product. Generic medicines are launched when the originator product's patent has expired.
In the EU a generic medicine is identified either by a company name plus its International Non-proprietary Name INN , or by its own invented brand name. Generic medicines are increasingly used by general practitioners, specialists, and hospitals as equally effective alternatives to higher-priced originator pharmaceuticals. Is there a difference between generic medicines and originator medicines? Generic medicines contain the same active ingredients as originator pharmaceuticals and act in the same way on patients.
Equivalent generic medicines may contain different non-active ingredients such as colourings, starches, sugars, etc.
In some cases, the active ingredient in generics and originators may also differ in salts and esters. And just as when originators modify the non-active ingredients, salts or esters in their products, these differences must not affect the therapeutic equivalence between the different products.
Who checks the quality, safety and efficacy of a generic medicine? In the EU, all medicines, originator or generic, have to be authorised before they may be produced and distributed to patients. To receive market approval, a generic medicine must be 'bioequivalent' to the originator product - i. Generic medicines are subject to the same European procedures as originator products and are carefully scrutinised by the competent authority.
Are generics really as good as their originals? Generic medicines must comply with exactly the same standards of quality, safety and efficacy as all medicinal products. And, just like originator products, once a generic medicine is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.
Are generic medicines really less expensive? Yes and the savings are significant. In addition, competition from rival generic products forces originators to reduce their own prices after - or sometimes before - patent expiry. How do generic medicines benefit patients and the national healthcare systems? When we use generic medicines, our national healthcare systems save considerable sums of money - many billions of Euros.
This frees up money to pay for other, more expensive treatments and services that patients need, including funding the research into new treatments and medicines. Generic competition also acts as an important stimulus for originator companies to focus on new research to create new patented medicines. When can EU patients have access to generic medicines? Generic medicines can be made available to patients in the EU only after the relevant patents on the originator product have expired.
How many years does a patent last on an original brand pharmaceutical product? As in other industries the standard patent is 20 years. But, uniquely for pharmaceuticals and plant technologies, this can be extended by up to a further 5 years by gaining a Supplementary Protection Certificate SPC. Can a medicinal product have more than one patent? Pharmaceutical products are covered by a number of patents, sometimes by as many as 30 to 40 patents or more.
In addition, a patent on a new use 'indication' , formulation, salt or ester can block the registration or marketing of a generic medicine for treatments where the base patent has already expired.
This is a strategy known as 'evergreening', which aims to prevent or delay competition from generic medicines by extending market protection through patents on minor changes to the original product. How long does it take to register a generic medicine in the EU? The registration of a generic medicine usually takes 1 to 2 years, but can sometimes take longer.
Moreover, access to the market in many EU Member States is delayed for generic medicines - as for originator products - by having to wait for pricing and reimbursement status. Generic medicines manufacturers also spend considerable time and money on developing their products, which are not, as sometimes alleged, mere 'copies' of the originator product.
In Australia, the European Union , [30] and the United States, certain formulations of orlistat have been approved for sale without a prescription. Patent and Trademark Office. The extension was granted on 20 July , [36] and expired on 18 June In Austria, orlistat is available under the brand name Slimox.
In Malaysia, orlistat is available under the brand name Cuvarlix and is marketed by Pharmaniaga. Society and culture[ edit ] Cost[ edit ] At times, such as in spring , orlistat has come into short supply, with consequent price increases because of nonavailability of one of the drug's components. Food and Drug Administration issued an alert stating that some counterfeit versions of Alli sold over the Internet contain no orlistat, and instead contain the weight-loss drug sibutramine.
If you miss a dose, it can be taken up to 1 hour after a meal and still be effective. However, if it is greater than an hour when you remember, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature in the original package, protect it from moisture, and keep it away from heat and out of the reach of children. Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Who should NOT take this medication? Do not take this medication if you: Many medications can cause side effects.
A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication.
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