Frequently Asked Questions About Generic Medications
What is a Generic Medication?
A generic medication is a drug that has the exact same active ingredient as the brand-name drug and produces the same therapeutic effect. This applies to the dosage, safety, strength, quality, mode of action, way of administration, and intended use. Generic medications are not required to contain the same inactive ingredients as the brand-name product.
Generic medications are significantly less expensive than brand-name drugs once they enter the market. A pharmaceutical company develops new drugs as brand-name drugs under patent protection. This protects their investment in drug research by granting the pharmaceutical company the exclusive right to manufacture and sell the brand-name drug while the patent is in effect.
When patents or other exclusivity periods expire, other manufacturers can file for approval to market a generic version of the brand-name drug.
Are Generic Medications as Safe as Brand-Name Medications?
Yes. The local health agency or ministry must first approve all generic medications before they are marketed, and they require that generic medications be of the same high quality and strength, purity, and stability as brand-name drugs. Generic medications use the same active ingredients as brand-name drugs and work in the same way. They have the same risks and benefits as brand-name medications.
Why Are Generic Medications Cheaper?
Although the active ingredients of generic medications are chemically identical to their brand-name counterparts, they are typically sold at a lower price than the brand-name drug. Generics are less expensive because the drug manufacturer does not have to replicate the original clinical trials to prove their efficacy and safety, reducing the cost of bringing the drug to market. Generics are not less expensive because they are of lower quality.
Are Generic Medications Always Cheaper?
Generally, yes. However, when a generic medication is first approved and marketed, costs may remain high (though lower than the brand-name drug) for 6 months because health agencies may grant the first generic manufacturer a “180-day exclusivity period.” The “180-day exclusivity” is awarded to the generic manufacturer who is the first to file and has done the additional work to bring the generic drug to market. This exclusivity allows the company to be the first (and possibly the only) generic on the market for 6 months. Generic manufacturers may charge higher prices during this time because there is little or no generic competition. Generic companies argue that exclusivity allows them to recoup expenses related to being the first to launch a generic on the market. Often, this is a disadvantage to the consumer, who is left with the higher-priced generic for 6 months.
Why Do Generic and Brand-Name Medications Look Different?
Most global trademark laws do not allow generic medications to look exactly like brand-name drugs. However, the generic drug must have the same active ingredients. The colors, flavors, and other inactive ingredients may be different, but the effectiveness of the drug remains the same.
Does Every Brand-Name Medication Have a Generic?
Not initially. New drugs are developed under patent protection, and most drug patents are protected for years after their filing. However, it may take many years to research and bring the brand-name drug to market. When the patent nears expiration, other pharmaceutical companies apply to the Health Agency or Ministry for approval to begin selling the generic version of the drug. A generic drug can be "tentatively approved" before the brand-name product's patent expires. Several companies may manufacture and sell generic versions of the brand-name product. However, some drugs may never have a generic because manufacturers may find these products unprofitable or too difficult to manufacture.
What Are "Branded Generics"?
"Branded generics" are exactly as they sound: generic drugs that have a brand name. These drugs are developed by a generic drug company or by the original manufacturer once the original product’s patent expires. The branded generic name is owned by the company.
IMS Health defines a branded generic as a prescription product that is a new dosage form of an off-patent product produced by a manufacturer that is not the originator of the molecule or a molecular copy of an off-patent product with a trade name. The branded generic must be bioequivalent to the original brand-name product.
Birth control pills are an example of a branded generic drug manufactured by several companies. For example, Aviane is the branded generic name of an oral contraceptive formulation containing ethinyl estradiol and levonorgestrel. Other branded generics are equivalent to Aviane but have different proprietary names, including products like Orsythia and Vienva.
Why do manufacturers give birth control pills these distinct "brand" names instead of just sticking with the generic name? Their goal is to get consumers to recognize and be loyal to the brand, ensuring they continue using the same product repeatedly. Additionally, many generic drug names, like ethinyl estradiol and levonorgestrel, can be difficult for consumers to pronounce and remember.
Who Can Develop a Branded Generic?
Branded generics, like regular generics, can only be developed after the original brand-name drug’s patent expires. However, any pharmaceutical company willing to file an abbreviated new drug application can manufacture branded generics. In fact, many large pharmaceutical companies that typically only create brand-name drugs are now acquiring or spinning off generic companies to tap into this lucrative business. According to the Generic Pharmaceutical Association, brand-name companies manufacture about 50% of the generic drugs on the market.
Are Branded Generics More Expensive Than Generics?
Branded generics are not always as affordable as true generics. With a brand name, some consumers may mistakenly assume that the branded generic is a higher-quality product than a true generic, but that is usually not the case. However, branded generics can be less expensive than the original brand-name drug.
What Are Authorized Generics?
An "authorized generic" is an exact copy of the brand-name version authorized by the original patent holder of the drug. An authorized generic is a prescription drug produced by a brand-name company under a New Drug Application (NDA) and marketed as a private-label generic. It is identical to the brand-name product in appearance (shape, color, markings) and, unlike a generic, the authorized generic has exactly the same inactive ingredients.
For example, Greenstone is an authorized generic provider and a wholly-owned subsidiary of Pfizer Pharmaceuticals. Greenstone is one of the oldest authorized generic distributors in the U.S.
For instance, Greenstone can market the authorized generic of sildenafil (VIAGRA), a widely used drug for erectile dysfunction originally manufactured by Pfizer.
Is a Biosimilar Also a Generic Drug?
No, a biosimilar is not considered "generic" in the same way that a traditional drug is deemed generic. A biosimilar is a biological product that is "highly similar" to a licensed reference biological product and has no clinically meaningful differences between the biological product and the original brand-name product in terms of safety, purity, and potency. The approval process for biological and biosimilar products is somewhat different.
Biosimilars are similar, but not exact, copies of active ingredients, as is the case with small-molecule drug generics. According to regulations promulgated by Global Pharmaceutical Agencies, a biological product can be considered "biosimilar" if data show that the product is "highly similar" to an already approved biological product. However, like generics, biosimilars will result in cost savings for the healthcare system and consumers; nonetheless, these products can still be very expensive.
Examples of approved biosimilars include:
- Nivestym (filgrastim-aafi), a biosimilar to Neupogen
- Ixifi (infliximab-qbtx), a biosimilar to Remicade
- Eticovo (etanercept-ykro), a biosimilar to Enbrel
- Amjevita (adalimumab-atto), a biosimilar to Humira
- Mvasi (bevacizumab-awwb), a biosimilar to Avastin
- Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin
Can I Get Information About Generic Medications From You (PanAmFarma)?
Of course, yes, we would be happy to assist you in finding a generic alternative at better prices if available.
Or you can ask your doctor or pharmacist for information about your generic medications. Keep in mind that your generic medication may not look like the brand-name product. When using generics and getting refills, your generics may not look the same from one refill to another because the pharmacy may have different generic manufacturers for your medication.
Most prescription drug labels now include the manufacturer’s brand-name drug and the generic name in parentheses.