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What is a generic?

Generics are safe

Why are generics less expensive?

Who makes generics?

How do I know who to trust?

How are generics helping you?

The choice is yours

A brief look at how pharmaceutical patents work



What is a generic?


Many definitions have been given for the term 'generic,' but in relation to human or animal medicines, nutritional products and health care products, 'generic' usually refers to a product that has the same active ingredient(s) (therapeutic component(s)) and shows the same results as a 'branded' product, and also costs less. Generics offer consumers the opportunity to save money on their animal's health care without compromising on quality.

Although most people are now happy to ask for generic alternatives for their own medications, they may not realise that there are generic equivalents available for many of the products they buy for their animals. 

The animal health generics industry is extensive and several countries have established their own animal / veterinary generics associations. Generic animal health products accounted for about 40% of world animal health sales in 2001. 

This percentage is increasing and, if the trend continues, generics could account for about half of the market by 2010.²

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Generics are safe

The generic of a branded product contains the same active ingredient(s), in the same strength and dosage that has been approved for use by the government. Generics are assessed via the same stringent procedures and strict government licensing standards as brand name products, ensuring they are manufactured to the highest quality standards. 

Only approved products made by approved companies can be offered for sale. 
A generic product goes through the same procedures for its approval and marketing authorization as the original branded product. The efficacy and therapeutic benefits of the product have already been proven through the clinical data and trials of the original brand. 

Once approved, a generic is interchangeable with the brand-name equivalent for all approved indications and conditions of use.

This means that changing from a brand-name animal health product or medication to a generic is safe for your animal. The inactive ingredients (those without medical properties), packaging, colour or shape may vary from the original, but the generic contains the same active ingredient(s) and works in the same way as the original product. 

Active ingredient(s) are clearly listed on product labels as required by government standards.

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Why are generics less expensive?

Although proven to be equal in terms of safety and effectiveness, generics are usually much less expensive than branded products. 

Because a generic medicine or health care product is the equivalent of an original product, the generic does not have all of the initial R&D (research and development) costs associated with it, like the original. 

Generics also tend to be more "value" focused, keeping packaging and advertising simple in order to ensure affordability. Generics may be produced in the least expensive way possible, but low prices do not mean low quality. 

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Who makes generics?

Many people don't know that most generics are produced by the very same reputable pharmaceutical companies or animal health product manufacturing companies that make the branded products. 

In fact, most pharmaceutical companies sell both branded and generic products.

Quite often, generic animal health products will be exactly the same as the branded original because:

the manufacturer will produce one product and market it themselves under  two labels, an original brand-name label and a generic label

or

the manufacturer will produce their original branded product for a second company which then markets it as their own generic (or sometimes as their own branded product as well). 

The distinction between brand-based and generic companies is becoming less clear cut, with companies looking for ways to diversify their business to get a bigger piece of the pie.

Large manufacturing and pharmaceutical companies are seeing the opportunities in producing one product under different labels in order to appeal to different sections of the market. Some generics companies today undertake their own research and development to improve on the original product that they first copied. 

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How do I know who to trust?

We are constantly bombarded with product ads, promotions, give-aways and information from sales people. Sometimes it is difficult to know the motives behind the sales pitch and which information to trust. 

There are ways for the consumer to make effective and informed decisions without feeling bullied by the big manufacturer's advertising or being completely reliant on a sales person. 

Behind every reputable animal health product should be a dedication to the animal health industry, to producing a quality product according to the highest manufacturing standards and to providing support for, and standing by, their product. 
Questions you can ask to help determine the quality of a product are:

Is the product manufactured in a facility that meets veterinary and GMP or ISO9001 standards?  

GMP (Good Manufacturing Practice) is the high standard of production deemed necessary by the government to ensure the quality of a product. ISO (International Organization of Standardization) is a worldwide organization that develops many different kids of standards. ISO9001 represents the Quality Management System Standard and regulates all areas of product design, development, implementation, management and production and is an internationally recognized standard. GMP and ISO9001 are assessed through an application process, strict regulation and auditing of manufacturing facilities, processes and product output. 

GMP and ISO9001 ensure that you can trust that the product inside the container is exactly what the label says it is, and that it will do what the label says it will do.


Is product and veterinary support available?

Is the manufacturer available for customer service support, enquiries or product information? When you or the retailer rings the manufacturer, are they helpful? Can they provide answers to your questions (either immediately or by looking into a problem and getting back to you)? Do they follow-up with you or the retailer? If necessary, is a veterinarian available for assistance with product queries or concerns?


Is product information available? 

Check with your retailer or online for available product information (brochures, informational leaflets or technical notes).

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How are generics helping you?

The days are gone when a generic meant a "budget copycat product from a backyard operation." Strict government controls ensure that a 'generic' today is an approved, proven and regulated product.

Generics benefit the animal health market, animal industry and consumers in many ways:

Generics offer a quality product in the form of a less expensive alternative.


Because generics are usually less expensive, they provide competition to branded products which helps to keep prices down, instead of allowing a potential monopoly of the market.


Due to price competition, safe and tested formulations are available to wider markets that previously may not have been able to afford them.


The competition of generics provides incentive to the brand-based companies to continually improve current medications and products, to identify new ingredients and to develop new products.


Generics companies often make their own improvements to original products.

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The choice is yours

While the distinction between brand-based and generics companies is becoming more blurred, the consumer's choice is becoming clearer. Generics enable consumers to save money on their animal's health care without compromising on quality. The availability of generics also means that certain medications or products, which may have been out of reach for some animal owners, are now affordable.
 
With active ingredients displayed clearly on packaging, consumers can compare for themselves and make informed and safe choices about their animal's health care products. 

If you have any questions concerning any animal health products or medications, ask your vet or animal health retailer, but remember that the choice of what to use is yours. There may be generic products available that could save you money. Your animal's health no longer has to be compromised because of a price tag. 

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A brief look at how pharmaceutical patents work


When a company develops a new medicine, they are granted up to 25 years of patent protection (i.e. a competition-free period). 

This is to protect their intellectual property and investment in the time and money it has taken to research and develop the drug / medicine. It gives them time to run clinical trials, license and register the product, and ultimately to market and sell it exclusively for a number of years before the medication is available to other manufacturers. 

Without such protection, the supply of new products would dry up, because it would not be economical to invest the necessary time and money into research and development.
 
Five years before a patent expires, generics manufacturers can begin non-commercial work on the product. 

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¹ New English Dictionary, Geddes & Grosset, New Lanark, Scotland, 1999

² Generics in the Animal Health Industry, Dr.med.vet. Uwe Gerecke, MRCVS, Animalpharm Reports, 2003

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s displayed clearly on packaging, consumers can compare for themselves and make informed and safe choices about their animal's health care products. 

If you have any questions concerning any animal health products or medications, ask your vet or animal health retailer, but remember that the choice of what to use is yours. There may be generic products available that could save you money. Your animal's health no longer has to be compromised because of a price tag. 

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A brief look at how pharmaceutical patents work


When a company develops a new medicine, they are granted up to 25 years of patent protection (i.e. a competition-free period). 

This is to protect their intellectual property and investment in the time and money it has taken to research and develop the drug / medicine. It gives them time to run clinical trials, license and register the product, and ultimately to market and sell it exclusively for a number of years before the medication is available to other manufacturers. 

Without such protection, the supply of new products would dry up, because it would not be economical to invest the necessary time and money into research and development.
 
Once a patent expires, other companies can apply to manufacture and sell a similar medicine - a generic. 
Australia introduced a 20-year patent protection period in 1988, putting it in line with Japan, the EU and the United States. 

Five years before a patent expires, generics manufacturers can begin non-commercial work on the product. 

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¹ New English Dictionary, Geddes & Grosset, New Lanark, Scotland, 1999

² Generics in the Animal Health Industry, Dr.med.vet. Uwe Gerecke, MRCVS, Animalpharm Reports, 2003

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