What Are the Generic & Brand Names for Fentanyl?

Fentanyl, an opioid with important pain management applications as well as a high potential for misuse, is a generic name for a substance that is included in a number of brand-name formulations.

Fentanyl can be found under various brand names, including these:

• Duragesic (transdermal patch)
• Sublimaze (injectable)
• Actiq (lozenge)
• Abstral (sublingual tablet)
• Subsys (sublingual spray)
• Lazanda (nasal spray) 
• Onsolis (buccal film)

The different names usually differentiate among the many ways to ingest the drug, such as intranasal spray versus a patch or lozenge, or they may indicate a different percentage of fentanyl within the substance.[3] 

Both the generic and brand name versions of fentanyl are overseen by the U.S. Food and Drug Administration (FDA) and monitored closely by law enforcement organizations. Even the smallest amount of fentanyl can be lethal if used incorrectly, so it is important to know the risks of using any amount of fentanyl in advance as well as how to respond if there are negative side effects. 

What Are Generic Drugs?

Generic medications are nearly identical to their brand-name counterparts in terms of active ingredients, dosage strength, method of administration, quality and intended use.[1] 

Generic drugs offer more budget-friendly solutions for patients, as they are often less expensive to begin with and also more likely to be covered by insurance. The lower cost is usually due to the fact that they don’t incur as many expenses associated with research, development and marketing as their brand-name counterparts. 

Even though they’re more affordable than brand-name versions of the drug, they must still comply with strict safety, effectiveness and quality standards set by regulatory bodies like the FDA.[1]

What Is the Process for Getting Generic Drugs Approved by the FDA?

The process for the approval of generic drugs by the FDA involves several steps, including the following:[2]

Submission of an Abbreviated New Drug Application (ANDA)

When producing generic medications, companies first submit an ANDA application with the FDA. This application includes data that shows their similarity with brand-name counterparts as well as assurances that they are safe and effective for patient use. 

Information typically includes active ingredients used, manufacturing processes used, labeling methods employed and intended usage purposes of each version of generic medication produced. 

Thorough Review & Evaluation

In this step, the FDA must conduct a detailed inspection of a drug submission’s chemistry, manufacturing processes and quality controls before performing tests to compare how its qualities stack up against its brand-name counterpart.

Studies to Show Similarity

Generic drugmakers must conduct studies that prove their generic version behaves similarly to its brand-name equivalent in terms of absorption into the body and concentration in the bloodstream. While animal trials can help test this claim, human trials must ultimately take place for validation purposes.  

Assessment of Labeling

The FDA performs an extensive evaluation of generic drug labels in order to make sure that accurate information is provided to healthcare providers and patients.

Factory Inspections

The FDA visits facilities where generic drugs are manufactured to ensure they comply with stringent quality and safety standards.

Awaiting Approval

Based on its review of an ANDA, results of bioequivalence tests, labeling details and manufacturing details submitted, the FDA will decide whether or not to approve the generic drug for the same use as the brand-name version.

Dealing With Patents

Sometimes, there may be patent-related matters to resolve. If the original drug manufacturer believes that patents covering brand-name drugs are being violated, legal action may be taken against the generic drug makers.

Entering the Market

Once approved, generic drugs can be released onto the market after all is clear with the patents. Doctors may prescribe them specifically if there is a shortage of the brand-name version, if the generic version is preferred by the patient or if insurance is more likely to cover the generic version.

Pharmaceutical Brands That Use Fentanyl Compounds & Their Differences

Fentanyl comes in different formulations and brand names, each tailored for specific routes of administration or clinical scenarios. 

Here is a breakdown of these brands and their differences:

Duragesic (Fentanyl Transdermal System)

Duragesic is the brand name of a fentanyl transdermal patch designed to slowly release medication through the skin over an extended period.[3] Every 72 hours, the patch should be changed for consistent pain relief.

Sublimaze

This is an injectable form of fentanyl designed for quick pain relief in urgent circumstances. It is usually only used in emergent situations in a clinical setting.[4]

Actiq

Actiq lozenges contain transmucosal (meaning swallowable) fentanyl intended to be taken sublingually. This medication provides quick pain relief, and it is often prescribed when other pain management methods fail.[3]

Abstral

This is a brand of sublingual tablets containing fentanyl that dissolve rapidly under the tongue.[5]

Lazanda

Lazanda offers a nasal spray formulation of fentanyl for quick and convenient administration and rapid absorption.[6]

Onsolis

This is a brand name for buccal soluble film of fentanyl designed to be placed directly against the inner lining of cheek for efficient absorption.[7]