Are generic drugs equal to brand name products?

I was on a brand name drug for over a year with no problems and the drug went to a generic version and slowly over three months my symptoms came back. I have since gone back on the brand name – paying 7 times as much for one month and have seen tremendous results. I am starting to feel back to the way I was before the generic drugs but am not sure how I am going to pay for the medicine. I am having talks with my insurance and will see if there are any other types of the same drug but not in generic form. Most people didn't/don't believe me when I say that the generic wasn't working, but I know that it wasn't...I'm the one using it! I am mad that insurance companies won't cover brand name medicines when a generic becomes available...especially if you try the generic for a few months and don't get results...the insurance companies are controlling our quality of life! How can someone who pays say $50 a month for medicine now come up with $400 a month? That is more than a car payment! I realize there is no amount of money that you wouldn't want to spend to feel healthy, but how do you come up with that kind of money every month? I would definitely recommend to anyone on generic and not having the same results to talk to their doctors. My doctors did switch me to a different brand name drug and I am going to try it and see what the results are.

Bravo Dr. Gupta,
I am exposed to this same question and processes on a daily basis.

The public DOES want to know why the cost difference of generic v. brand/trade name. You have touched the most key point of active and inactive ingredients.

The fact that the average Pharmaceutical manufacturer, in 2007 and probably more in 2008, spent approx. $850Million dollars in bringing their "wonder" drug from research to market. This drug is granted 20 years to recoup their expense. The Generic manufacturer files an application with the FDA to manufacture their generic version after loss of these patents, at a greatly reduce expense. We still need the inspiration of the originator to be rewarded, if possible.

Allergic reactions are another main topic on substitution. We should VALUED Both sides of the marketing of our medications.

Sincerely,
J.A. Tinervia CPhT, MBA
Pharm Tech Faculty

I take a number of generic with good response, the name brand are specified but I appreciate hearing Dr. Gupta's remarks.

You should always check with your pharmacist first. If you are prescribed a controlled release drug, you might not want to take the immediate release generic brand. Not only do you have to take the drug more often, the side effects can be more severe.

Just would like to clarify... brand name drugs cost a lot more than generics because it costs about a billion dollars and 10 years to discover and develop them. Marketing the brand does cost money, yes, but a fraction of what it takes to develop a drug and run clinical trials to make sure they're safe and effective. Once the patent is expired, a generic company doesn't have to do any of the legwork. It's all been done for them. No wonder they can sell them so cheaply.

As a physician and former research fellow at the NIH, I have found that there are even differences between the same active ingredients. The proprietary synthesis and crystallization of the active ingredient is different for the brand name drug versus the generic. Whether that difference translates into real clinical differences in efficacy or side effect profile may not be known, but the studies that originally validated the drug in the first place are based upon the brand.

As a pharmacist, Joseph does a great job summarizing the issues facing big companies. He mentioned that it cost drug companies about "$850Million dollars in bringing their “wonder” drug from research to market," but what is not seen is that it takes about 200 new drugs to go to trial before one usually makes it to market. Companies must offset the expense of drugs that go to testing but fail to make it to market. Another issue that he mentions is that the patent is only given for 20 years, but that change is recent. Until recently, drug patents were only given for 17 years from the date of drug application which gave companies even less time to reap the benefits. "The recent change aligns U.S. law with the provisions of the Uruguay Round Agreements under the General Agreement of Tariffs and Trade (GATT)." The financial situations that these drug companies is a tough one.

Hi Don:

I believe that most meds you can do the generic. But I was told by two doctors, that when it comes to thyroid medication, you should take the brand name, because there is a slight difference in strength. I also wanted to ask Dr. Gupta if he can recommend a very good Thyroidologist, or a Endocrinologist for me. I would really appreciate it if he could. This is for someone who lives in New York City, but would be willing to travel, if he knows someone who is great.

Thank you,

Marcia

If, as Dr Gupta says, the so-called inactive ingredients that can alter how a drug is released ... seems like they aren't so inactive then, especially in an extended release form.

Like Ireland, I had no problems with my name-brand drug (for blood pressure) but, had alternating bp spikes and light-headedness on the generic which is the only thing my government insurance now covers so, I pay for my own name-brand. (Additionally, there has been a recall of the generic and still the government insurance won't cover the name-brand!)
Unlike Ireland, I won't accuse the insurance companies, at least not totally. Probably many of the decisions are set simply by one's employer when the decision is made by the type of healthy insurance policy purchased. In my case, the federal government decides what they want the military/retired military insurance program to cover; the federal government through their formulary committees are setting the rules, parameters of what the drug coverage will be and makes certain generics mandatory. And, for everyone, the federal government makes the laws that allow insurance companies to mandate generics and the federal government through the FDA makes the decisions as to what generics are supposedly equal to name-brand.

The FDA does not rerquire safety testing for generic drugs. Essentially equivalent bioavailability/pharmacokinetics is all that is required for a generic to be marketed.

I have been taking synthroid since 1970. I had my thyroid removed at the age of 13. I have always taken the brand name. My mail order pharmacutical company sent me the generic one time. I gained 12 pounds! I make sure my physician specifies brand name necessary on my RX.

I am told that the permissible variation in the amount of active drug in a generic pill is much higher than in the name-brand pill. This together with the effect of different inactive ingredients will influence how the medication is absorbed, particularly so, in the case of extended release medication. This I have found it to be true from my personal experience.

There are a few comments listed here from patient's with thyroid conditions. While the FDA does have standards for generic drugs being equivalent to the branded version of the medication, the FDA actually allows up to a 20% (some cases have been as high as 33%) variation in the amount of active ingredient in the medication.
For most medications this has little if any real clinical effect. For example if you are supposed to be on 25 mg. of a bloodpressure medication the generic may have as little as 20 mg. or as high as 30 mg, however since the next dose is 50 mg. there is little clinical difference between the generic and branded versions of said medication.
With Synthroid or Levoxyl (levothyroxine is the generic) the dosing is so small and narrow that the above example does not always hold in the clinical setting. For example, if a patient is supposed to be on 125 mcg. of Synthroid (20% is 25 mcg.) you could be receiving as little as 100 mcg. or as high as 150 mcg. These medications can be dosed at 100 mcg, 112 mcg, 125 mcg, 137 mcg, and 150 mcg. As you can see, the 20% variation allowed by the FDA for generic manufactures encompasses 5 entire doses of thyroid hormone and a different amount of medication allowed may not be the correct dose for a patient.
Lastly since generic medicine is considered equivalent a pharmacy may change manufacturers for their levothyroxine (the generic) without notifying the patient, even though the dose of medication may not be right for them. Here is a statement on the subject from AACE (American Association of Clinical Endocrinologists).

http://www.aace.com/pub/pdf/guidelines/AACE-TES-ATA-ThyroxineProducts.pdf

hello Doctor,
hello Doctor,
I was just diagnosed with low thyroid. I start medication two days ago. The doctor prescribed me levaxol, but the pharmacist gave me the generic band, levotyroxine. It is the same? I'm a little concern because I read that when is a thyroid medication, you should get the brand one.
Thank you
Erminia

I find this interesting given that my 11 year old son takes multiple seizure medicaitons all in the generic form. Recently, we were dispensed a different generic form of one and since then, he has been extremely sedated and drooling like a faucet. with his neurological damage, a little drooling is typical for him, but the excessive amount is not usual and can be quite dangerous form him. If he doesn't drool, he sounds like he is drowning in his saliva putting him at risk of aspirating. We cut the dose back today and I can already see a difference. It is another example showing that we need the same FDA regulations on generic drugs and monitoring.

For the most part, as a pharmacist I highly recommend generics. Certain medications, primarily those that require titration and tight dosage controls, are the exception.

Digoxin, Phenytoin, and Thyroid Replacements are some examples. There are quality generics for these products, and so long as a paitent is stable on one generic (or the original trade name drug), my recommendation is to not change to a different manufacturer if possible.

Unfortunately, generic manufacturers do not all have reliable supply chains, and many pharmacies are compelled to stock different manufacturer's versions of the same drug.

For this reason, I suggest to anyone on one of these medications to use the original branded product if they can afford it.

As much as pharmacists, insurance companies and some Drs. want to believe generic are not different than brand, I am the patient and my Dr. and I saw the devastation of generic anti-depressants. Some are ok, but many are not, and yes, it's the inactive ingredients that make it so dangerous. It's like going off of them immediately, which is NEVER recommended. People are crashing and burning and nothing is being done about it. Suicides have happened, but they'll never be able to prove it. My Dr. files an FDA complaint with every patient, along with myself, but, to no avail.

Bottom line it should be up to the doctor and patient,not an insurance company,mediciad etc.If the doctor writes brand name it should be mandatory that the patient gets it.

I had my thyroid removed in 1991. My doctor and I agree that name brand Synthroid is the medication I should take. I tried the generic form with very poor results. With my insurance, the cost for the name brand medication is actually cheaper than the generic. If you have insurance check to ensure that the generic medications always cost less.

What really gets my goat is these new drugs where they put two generics together and then charge an arm and a leg for it! I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this! The unthinking public is going to pressure their doctors into giving them something just because it’s new, when something old or generic would do the job for cheaper.

Generic and Brand can be hugely different for the sensitive population...

It is bothersome when the expert doctors and others start sounding like parrots – regurgitating the same OLD information, touting the lax FDA studies and being shills for the insurance companies who have everything to gain by forcing use of generics as a form of long awaited cost control. Cost control that ends up costing consumers and insurance more on the medical benefits end when the generic ends up to be a complete failure on the unsuspecting patients. Patients, who, for some reason, trust the experts, doctors and insurance to do the right thing. The right thing has not and probably will not be done with regard the brand medication versus generic. Congrats on being a bunch of lemmings and believing what is spoon fed to you by the media.

I have been using generics for a long time more than 3 years. I find it good only since the active ingredients are same in both brand and generics. I have been getting quality generics from good manufacturers at International Drug Mart. I feel comfortable and healthy too on having generics.

With the current news concerning control of generic and veterinary drugs, what is your view of Missouri's removal of Pharmacy Board oversight of prescription medication such as propofol, if the medications are sold for use in animals by third party outlets not having a pharmacist? Currently the pharmacy board has not right to oversee any company selling these drugs and cannot enter these to review dispensing to the public. This does not pertain to Veterinary Pharmacy within an animal clinic as the veterinarian is licensed to prescribe and dispense these drugs. But these are retail outlets that employ high school students and otherwise untrained employees to dispense prescription medication.

My husband is a pharmacist for CVS. CVS pushes the generics, and also makes the pharmacists push them.

I have a MCTD and have to take several medications. I am sensitive to drugs and not only can tell the difference between a brand name and the generic, I can tell when CVS buys a generic from another company.

We get no discount for the brand name, but I need what works.

What is so frustrating is that most doctors and pharmacists do not believe there is a difference between the brand name and a generic, and sometimes the differences are unbearable.

I was put on Effexor XR anti depressent drug was doing fine until the Druggest put me on generic venlafaxine75 mg I now am back to crying I am sad and I have fibroymagalic for 16 years . do you think it is because the gereric is not doing the same as the name brand?

A number of patients with a history of good results on brand name antibiotics began experiencing difficulties when a generic was substituted. Therefore, if you have prescribed a brand name tetracycline for a patient using antibiotic therapy and have not specified d.a.w. or no substitutions, your patient is probably taking a generic version and may be having a less than significant response to the treatment. Some generic versions have been found to be ineffective for this treatment.

Does every brand- name drug have a generic counterpart?

How long does a drug have to be on the market before generic drug makers can copy or manufacture it ?

James,
The short answer is that when a Pharmaceutical Mfrgr requests approval of the FDA for a new Medication, they submit a New Drug Application or NDA. This NDA upon approval is given a 20 year "protection" patent that allows the manufacturer a "window" of opportunity to 1st prove to the FDA that the drug will "clinically proven" (with 3 levels of testing) that the medication will therapeutically perform as specified over a clincal trials testing (3). They must prove through these clinical tests that the medication is proven to be "safe and effective" on the listed disease/disorder therapies. They have 20 years to prove to the FDA this safe & effectiveness, then be allowed to market the medication for the proven therapies. This drug research to market averaged $850M per drug in 2009 so the manufacturer does warrant the protection by the FDA. After, proven the manufacturer can market the medication for the balance of the 20 year period under protection of the patent protection. The generic pharmaceutical manufacturers then have the "free reign" to copy the original brand/trade name with the Abbreviated New Drug Application ANDA. Their Generic must be Therapeutically Equiv. to be allowed to market the generic to the public. This is a brief explanation James, so you can see it tends to be lengthy and involved by all parties. We are talking Billion and billions of dollars though so many are involved. I'm sure i've run out of room....

Kaycee,

No, only the brand/ trade name medications that have lost their patent protection can be substituted by a quality "generic" drug that has been approved by the FDA for market. The above comments give you a brief explanation of the approval process. It is based on the manufacturer's application (ANDA) to the FDA that the medication is "safe and effective" for the prescribed disease or disorder's therapy. Also, that the medication is therapeutically equivalent (AB1, AB2, AB3, ...BX) rated for prescription applications. So, if there is no approved generic medication for your brand name or trade name drug, it is because the manufacturer is still being protected by their patent. Which They Do warrant the approved time to recoup their $$$ vast expenses in bringing the drug from research to market. We Need to Keep theses guardians in place...or they will fade into reality.

Thanks