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The Difference Between Brand Name and Generic Drugs

THE DIFFERENCE BETWEEN BRAND NAME & GENERIC DRUGS

The vast majority of drugs dispensed in pharmacies are generic drugs. In some circumstances, patients request branded products to be distributed, or the prescriber decides to prescribe impressed rather than a generic product. Does it matter which drugs are used by patients? What is the difference between branded and generic drugs? Can the patient request the brand product to be dispensed on a ‘generic prescription’?

What Is The Difference Between Generic Drugs Vs Branded Drugs?

Branded drugs are given a name by a Company that makes a drug. Branded name always differs from the International Nonproprietary Name (INN); the generic name is usually the name of the active ingredient. Branded medication may include drugs developed originally for the first time to treat a specific condition. For example, Lipitor (produced by Pfizer) was the first brand of atorvastatin licensed to treat high cholesterol. After the expiry of patent protection in 2016, other manufacturers began to produce generic versions of atorvastatin which became available at a much lower cost.

A Company producing a generic drug may decide to name it, making it a branded generic product.

Branded drugs: patent protection

When a drug has been developed, a Company that makes it has exclusive rights to produce it. This is secured with patent protection which usually lasts 20 years and is applied at the early stages of drug development. It takes around 10 years to take a drug from the discovery phase to the licensing phase, where drugs are available for patients.

Once a patent expires, other manufacturers can produce generic versions of the same medication after passing all necessary legal requirements, including bioequivalent studies.

In most cases, branded drugs are more expensive, at least during the patent duration, as a Company that makes it needs to recuperate the high cost of drug development.

Generic drugs contain the same active ingredient as branded drugs and are used to treat the same disease using the same dosage regiment.

Are Branded Drugs Better Than Generic Drugs?

Licensing and production of drugs are strictly controlled. The generic manufacturer needs to demonstrate that the new generic medication is equivalent to branded medicine in terms of efficacy and safety and that it is therapeutically equivalent (bioequivalent) (EMA, 2011). This does not mean that the generic medications need to look the same, have the same tablet shape or use the same excipients in the production of the drugs. All of these commonly differ between drugs.

Bioequivalent requirements between branded and generic drugs

Bioequivalent studies are conducted in healthy individuals and must be performed before any medication is given a license. The food and Drug Administration (FDA) and European Medicines Agency (EMA) look at two parameters to determine if two medications are bioequivalent:

  • The area under the curve (AUC)
  • The highest concentration of medicine in the body (CMax)

AUC reflects plasma concentration (amount of the drug) over time after the patient takes the drug. It is measured by taking blood samples of the patient at specific times. This is a valuable parameter as it shows how much medication gets into the body and how fast it is cleared from the body.

Cmax is self-explanatory as it reflects the maximum concentration of drugs in the body after a drug is taken.

AUC and Cmax for new generic drugs must be within 80-125% of a reference drug (branded drug) with a 90% confidence interval (we are 90% certain/confident that our range of results contains the true mean). In other words, 90% of the time, our results for AUC and Cmax must fall within 80%-125%. License is not given to generic drugs which fail to meet those criteria.

The range of 80%-125% has nothing to do with how much active ingredient generic medication contains compared to a branded product.

One of the best examples of systemic review and meta-analysis on branded versus generic drugs is Clinical Equivalence of Generic Brand-name Drugs Used in Cardiovascular Disease. This research paper looked at branded and generic bioequivalent medicines from 1984 to 2008 to treat cardiovascular conditions. This covered 47 studies, of which 81% included randomized controlled trials. The main conclusion of all studies was that branded and generic drugs resulted in similar clinical outcomes (Kesselheim et al., 2008).

Can The Patient Request Banded Product Be Dispensed?

Most of the prescriptions are written generically. Patients may request to have a branded product supplied; however, it is unlikely that the pharmacy will fulfill this request. This is mainly due to the price difference between generic and branded drugs. When a prescription is written generically, pharmacies receive reimbursement (payment) from NHS for the cost of generic drugs. If a branded product is supplied, a pharmacy loses supply. The difference in price between generic and branded drugs can be significant. Occasionally, pharmacies have different deals with branded product manufacturers, and the branded drug is supplied by default.

The table below lists examples of a few drugs to show the price difference between branded and generic drugs and lists reimbursement from NHS for the supply of generic medication (AHH, 2019). Some of the listed drugs include the most prescribed drugs in the UK.

Drug name

Price of branded drug Price of generic drug NHS reimbursement (generic)

Sildenafil 100mg tablets (4)

£23.50 (Viagra) £0.74 £0.80

Amlodipine 5mg (28)

£10.50 (Istin) £0.65

£0.71

Atorvastatin 20mg (28)

£26.64 (Lipitor) £0.77

£0.81

Ramipril 5mg tablets (28)

£9.02 (Tritace) £3.75

£4.63

Sertraline 50mg tabs (28)

£17.82 (Lustral) £1.49

£0.82

Omeprazole 20mg caps(28)

£15.87 (Losec) £0.78

£0.83

Are All Drugs Issued Generically?

Certain medications should only be prescribed by their brand names to maintain the same supply and minimize any risk associated with brand switching. Some common drugs brands prescribe include anti-epileptic drugs, including phenytoin, carbamazepine, phenobarbital, and primidone.

Other examples of a group of medicines prescribed by the brand include drugs with a narrow therapeutic index (the window between therapeutic and toxic levels is small) and modified-release preparations.

In conclusion, generic drugs bring several advantages to patients and NHS. Lower cost for generic medications drives prescribing. Generic drugs contribute to better availability and faster supply to patients. Strict legal requirements (bioequivalent studies) and licensing processes ensure that generic drugs have almost the same therapeutic actions as branded drugs.

Final Words from Druggist

Generic drugs and Branded drugs work the same. The difference you can find is Brand name drugs are sold for a bit high prices, whereas you can get the generic version of any medicine at the lowest cost. Generic drugs contribute to better availability and faster supply to patients. Strict legal requirements (bioequivalence studies) and licensing processes ensure that generic drugs have the same therapeutic actions as branded drugs. There are few variations in inactive ingredients, brand name drugs compared to generic drugs. But both drugs have the same effectiveness in the body.

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