On the shelves of a drug store, you will often see multiple versions of the same medicine. For example, when shopping for over-the-counter pain medication, you may find Tylenol and Advil on the shelves, as well store brand acetaminophen and ibuprofen. The former are brand-name drugs, while the latter are generics. Brand name and generic versions contain the exact same active ingredients and work in the same way, but the generic is usually significantly cheaper.
This same distinction exists for prescription medications – 90% of all prescriptions filled in the US are for generic drugs. When a new drug is introduced to the market, however, it will generally only be available as a brand-name. That is because most new drugs are usually under patent protection, a legal mechanism that gives the company that invented or brought it to market exclusive rights to sell it for a period of time.
Patents are meant to encourage innovation by providing a financial incentive to invent new drugs and helping to cover the massive costs of drug development. When a company owns a drugs’ exclusive rights, they can charge higher prices because they do not face any competition. However, in the interest of keeping prices down over the long-term, these rights are not permanent – most drug patents last 20 years. Once this patent period runs out, other manufacturers may produce generic, cheaper versions of the drug.
Generics vs. Brand-Name Drugs
All drugs, even those that are still under patent protection, will have a generic name. An example in ALS is edaravone, which is the generic name for the drug that is sold under the brand name Radicava in the US. The generic version may look slightly different from the brand-name but it must have the same active ingredients, dosage, and route of administration.
There are many pharmaceutical companies that specialize in manufacturing generic versions of drugs whose patents have run out. Generic drugs face a much simpler approval process than new treatments, which must go through multiple phases of clinical trials to demonstrate safety and efficacy. Manufacturers only need to prove that a generic is bioequivalent to the original treatment, meaning that they both work in the same way and provide the same clinical benefit. This is usually accomplished through a simple trial in which volunteers alternate between the generic and brand-name versions to ensure they both have the same therapeutic effect.
Generics and Drug Pricing
Prices for these generic drugs are usually much lower than their brand-name predecessors. This lower cost is due in large part to the fact that generic manufacturers do not have to invest in expensive research and development for their drugs, as that work will have already been completed by the original sponsor. Additionally, multiple generic pharma companies may produce versions of the same drug, leading to competition that can also help keep prices down.
This system is meant to create a balance between allowing companies to generate profit from their inventions and keeping drugs affordable for patients. It allows drug sponsors to maintain exclusivity for a window of time that will help them to recoup their R&D costs, generate profit, and provide dividends for their investors. Then, when the patent clock wears out, the hope is that competition from generic medicines will bring prices down and the drug will be more affordable from that point on.
Riluzole: An Example in ALS
For ALS progression, there is currently only one treatment with generic availability: riluzole. In 1995, riluzole became the first treatment approved in the US to treat ALS progression, after trials demonstrated it could have a modest benefit for people with the disease. Following approval, the drug was sold as an oral tablet under the name Rilutek. In 2018 and 2019, additional formulations of the drug as a liquid suspension, Tiglutik, and a film that can dissolve in the mouth, Exservan, were also approved. New formulations of a drug such as these are often sold under different brand names than the original. A new formulation is also eligible for its own drug patent, with its own 20-year period of exclusivity.
In 2003, generic forms of Rilutek first became available, as the original drug patent expired. (The 20-year clock for drug patents begins when the patent is filed, not when the drug is approved.) Since then, many companies have introduced generic forms of riluzole oral tablets. However, because the liquid and film formulations were invented more recently, they are still under patent protection, and only the brand-name versions are currently available.
ALS TDI: Working to Find Treatments for Everyone with ALS
ALS is an extremely complex disease. At the ALS Therapy Development Institute (ALS TDI), we know this means that it will take many treatments to end ALS for everyone with the disease. That’s why every day we’re working to identify effective treatments for the disease. As the Drug Discovery Engine for ALS, it is our mission to continue this work until there are effective treatments for everyone with the disease.
To learn more about our research to end ALS, visit: https://www.als.net/als-research
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