Expiring drug patents and what it means to you
The average life-span of a drug patent is 20 years, but in most cases about half of that time is spent in testing to get the product to the marketplace. That’s because it can take up to eight years for the company get approval from the U.S. Food and Drug Administration (FDA) due to testing, studies and experiments to document the side effects and how effective the drug is on human patients.
Once the patented drug expires, companies can start developing a generic option for the name-brand. In turn, the name-brand sales typically drop by 80% as consumers opt for the less expensive version of the same drug. But is it the same?
The process for developing a generic option for a drug comes with much scrutiny. The companies must produce a drug with the identical makeup of the original drug, and pass the same manufacturing and packaging standards. But before all of that:
- The original patent must be expired.
- The original manufacturer must certify that the patents have not been infringed upon, are invalid, or otherwise unenforceable.
- There have never been any previous patents on the drug or in countries where the drug has no protection by law.
So what’s the difference between the name-brand and the generic version? Cost. Generics have saved Americans $1.67 trillion over the last decade. Generic drugs cost less because the development and marketing costs were built into the cost of the name-brand. Due to trademark laws, generics cannot look or taste exactly like the name brand, but the active ingredients must be the same, ensuring they both have the same medicinal effects.
The following name-brand drugs patents are scheduled to expire this year:
Symlin – Used with insulin, can help control blood sugar in people with diabetes. It’s always used with insulin.
Tecfidera – a fumaric acid ester used to treat relapsing forms of multiple sclerosis (MS).
Flector – can be used as a topical pain reliever for the treatment of acute pain due to minor strains, sprains and contusions.
Cetrotide – can prevent premature ovulation in women undergoing fertility treatments with controlled ovulation.
Omtryg – is used together with diet and exercise to help lower triglyceride levels in the blood.
Bevespi Aerosphere – works to help open airways and keep them open for patients with COPD.
Otovel – is used to treat a type of middle ear infection in children called acute otitis media with tympanostomy tubes (AOMT) caused by certain bacteria.
Byvalson (Nebivolol & Valsartan) – is a combination medicine used to treat high blood pressure (hypertension) in adults.
Rescriptor – can treat HIV, the infection that causes AIDS. It doesn’t cure HIV or AIDS, but combinations of drugs that treat HIV infection may slow the disease progress and prolong life.
Natroba – a topical suspension is used to treat head lice in adults and children who are at least 6 months old.
Kovanaze – is a nasal spray used as dental anesthesia.
Firazyr – for the treatment of sudden attacks of hereditary angioedema (HAE).
Noxafil – can treat or prevent fungal infections, especially in people with weak immune systems.
Cardiotec – is used for nutritional support and dietary supplementation.
Troxyca ER – is an extended release capsule formulation of oxycodone combined with naltrexone.
Yosprala – a prescription medicine used in people who have had heart problems or strokes caused by blood clots, to help reduce their risk of further heart problems or strokes, and who are at risk of developing stomach ulcers with aspirin.
Cystaran – can prevent the buildup of cystine crystals in the kidneys in its oral form. Other forms can treat cystine crystal buildup in the eye (cystinosis).
Lumason (sulfur hexafluoride lipid-type A microspheres) – is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, and in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.
Synribo – is used for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.
Ionsys – is used to treat severe pain.
Brimonidine and brinzolamide ophthalmic – can reduce the amount of fluid in the eye, which decreases pressure inside the eye.
Durezol – can treat eye irritation and inflammation.
Ask one of our pharmacists if your prescription is available as a generic.
Sources: Association for Accessible Medicines, Upcouncil, RxSaver, U.S. FDA