Generic Frontline available

[MagRam]

For those of you still using Frontline and Frontline Plus apparently then patent protection expired in March. Generics are starting to hit the market now. The first is called Pet Armor and is currently available only at Sams Club and Walmart. More generics are expected on the market soon. The cost is about 3 - 4 per dose less than Frontline.

[Rave]

Vet friends have told me while the main ingredient in these generics is the same as Frontline, the delivery mechanism (i.e. how it gets into the dog's system) may be different and may not be as effective. Caveat emptor.

[MagRam]

Vet friends have told me while the main ingredient in these generics is the same as Frontline, the delivery mechanism (i.e. how it gets into the dog's system) may be different and may not be as effective. Caveat emptor.

 

Most vets sell Frontline in their offices - often for higher prices than available in the store. I have even had some (falsely btw) try to tell me I needed a prescription or an office visit to buy Frontline. There is a financial incentive for vets to continue to push FrontLine over generics. Plus there is the natural tendency to simply stay with what works.

 

Generic drugs are, however, subject to the same rigid controls by the FDA. See FDA Statement on Generic Drugs

 

See the following excerpt from the FDA about generics. Obviously it is referring to human testing as that is most of what they do but the same standards apply:

 

Myths and Facts about Generic Drugs

MYTH: Generics take longer to act in the body.

FACT: The firm seeking to sell a generic drug must show that its drug delivers the same amount of active ingredient in the same timeframe as the original product.

 

MYTH: Generics are not as potent as brand-name drugs.

FACT: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs.

 

MYTH: Generics are not as safe as brand-name drugs.

FACT: FDA requires that all drugs be safe and effective and that their benefits outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.

 

MYTH: Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.

FACT: FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year in all firms to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

 

MYTH: Generic drugs are likely to cause more side effects.

FACT: There is no evidence of this. FDA monitors reports of adverse drug reactions and has found no difference in the rates between generic and brand-name drugs.

 

What Is Bioequivalence?

Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug.

 

One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.

 

Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them.

[Rave]

These were vet friends who are quite honest, not anyone trying to sell me anything. I'm a huge fan of generics, but I plan to wait and see if these work as well as Frontline does for my pups.

[MagRam]

These were vet friends who are quite honest, not anyone trying to sell me anything. I'm a huge fan of generics, but I plan to wait and see if these work as well as Frontline does for my pups.

 

That's fine. I just wanted to point out generics are also subject to stringent manufacturing protocols and required to show bioequivalency. The generics are required to go through FDA approval as to their quality - just not required to fully replicate all clinical tests because they have already been done.

 

I think it is common to be a bit skeptical until the generics have been out for a while. I trust generics for myself so I am inclined to trust them for my dogs as well. Each person should make their own decisions on that but since I did not know this was available until my wife saw the ad on tv last night I thought I would let people know. I have no interest in either company or sale of either product. I just know many of my friends are on constant lookout for ways to cut expenses when they can so I thought I would share.

 

BTW - I asked a vet friend also and he was not yet aware of generic but his colleague thought there was more than 1 generic already available with similar results to Frontline.

[gcv-border]

I approach using generics with caution. Although the FDA says that:

 

"One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug." from the FDA Statement on Generic Drugs.

 

BUT, the meaning of bioequivalence is pretty flexible. Here is a quote from another medical website (adultadd.info)-- "The generic medication must also be “bioequivalent” to the brand name drug, meaning that it must “be shown to give blood levels that are very similar to” the brand name product. More specifically, it must reach a blood serum level that is 80% to 125% of what the brand product achieves. While the spread is generally much smaller, in extreme cases this could be a difference of over 50%."

 

To me, a difference of 20-25% in blood levels is pretty significant. Without access to the actual data or how it was analyzed, I can not tell if the 80-125% levels are based on an average of all patients or if it is based on individual data points. I would assume that a brand-name drug (or pioneer drug as it is also called) would also have a range of blood levels.

 

I base my decision on use of generics dependent on how exact I believe that the dosage should be. For one of my medications, I use a generic because I don't think that achieving a precise blood level is critical, whereas for my second medication, I feel more comfortable using the brand-name since I believe/hope that the dosage is more exact. Although I must admit that one can not know the exact blood level dose in an individual without testing specifically for blood levels.

 

For Frontline, I would believe that a generic should be similar enough to the brand-name (assuming that the delivery system is equivalent) since the Frontline 'dosage' is not very exact - i.e. one packet treats a fairly wide range of weights (for example, 30-50 lbs).

 

JMO, yours may differ.

 

Jovi

[juliepoudrier]

For Frontline, I would believe that a generic should be similar enough to the brand-name (assuming that the delivery system is equivalent) since the Frontline 'dosage' is not very exact - i.e. one packet treats a fairly wide range of weights (for example, 30-50 lbs).

 

JMO, yours may differ.

 

Jovi

^^I agree with this. I also think that if you're (general you) one of the folks who has found either Frontline or Advantix/Advantage to be less effective of late, then there can't be any real harm in using the generic and saving some money, because if the brand name isn't working well for you, then perhaps the generic will work better (the different carrier may actually increase efficacy) or at the least, not be any worse. For people with a lot of dogs and/or not a lot of income, it could be the difference between some protection and no protection at all (that is, a cheaper product that isn't quite as effective is still better than using nothing if you can't afford the more expensive alternative).

 

J.

[Mark Billadeau]

the Frontline 'dosage' is not very exact - i.e. one packet treats a fairly wide range of weights (for example, 30-50 lbs).

This is true for every drug. I know of no drug which is sized for the exact weight of every patient (drug doses are in mg/kg of body weight). The only way manufacturers can prepackage drugs is to make weight ranges which start at the 1x the minimum effective dose and go up in dose but stays below a dose that shows adverse reactions. In the example of 30-50lbs this means the dose is between 1x (50lbs) and 1.67x (30lbs) of the effective minimum dose depending upon where in the weight range the patient's body weight falls.

[gcv-border]

This is true for every drug. I know of no drug which is sized for the exact weight of every patient (drug doses are in mg/kg of body weight). The only way manufacturers can prepackage drugs is to make weight ranges which start at the 1x the minimum effective dose and go up in dose but stays below a dose that shows adverse reactions.

 

Duh! Of course. Light bulb moment for me! (as I bang head against wall). Most of my 'medicating' is on my livestock for which I dose mostly by weight - so my mind immediately went to that scenario. Interesting to me to realize that I can be more accurate with dosing for my animals than for myself (since any meds I take -although I don't take many - are in tablet/pill/capsule form). Sheesh!

 

P.S. Just in case I am misunderstood, I meant Duh! directed to me - since I had not thought about the inexactness of dosing in human medicine. It is good to be shown the error of my thinking.

 

Jovi