safety concerns

Have you ever heard of authorized generic drugs? Most people, including physicians and pharmacists have no idea what they are. That’s largely because the Food and Drug Administration tells the world that all FDA approved generic drugs are equal to their brand name counterparts. But we have lost faith in the FDA’s ability to monitor generic drug manufacturing in distant lands. Can authorized generic drugs fill the void? At the bottom of this article you will find a list of authorized generic drugs.

The FDA has to tell the American public about generic drugs. That’s because of the passage of the Food and Drug Administration Amendments Act (FDAAA) on September 27, 2007. Here is the FDA’s link to authorized generic drugs.

The only problem with this list is that it does not tell you the company that is actually distributing/selling the authorized generic drug. It only tells you the company that applied for the NDA (new drug application). That makes it hard for physicians, pharmacists or patients to know what company is actually selling the authorized generic drug for any particular brand name medicine.

Insurance Companies Embrace Generic Drugs

Generic drugs are copycat versions of brand name medicines. That means they contain the same active ingredient. According to the Food and Drug Administration, all generic drugs are equally good as long as they have been approved by the agency.

But the generic company does not have access to the secret (proprietary) recipe that the brand name company used. In addition to different inactive ingredients (binders, fillers, dyes), the release formulation may be quite different. That means that the way the drug dissolves in your digestive tract can be quite different from the brand name. That was the problem with Budeprion XL 300, a generic form of Wellbutrin XL 300.

Generic Wellbutrin XL 300:

Insurance companies love generic drugs because they are so much less expensive than the brand name products. They often refuse to pay for brand names if there is a generic option available.

Take the antidepressant Wellbutrin XL 300, for example. The brand name costs between $1,700 and $2,000 for a month’s supply. The generic, bupropion XL 300, costs between $22 and $100 for the same amount, depending on the pharmacy.

It’s hardly any wonder that many insurance companies won’t pay for the brand name once the generic is on the market. But many readers of our syndicated newspaper column have reported that certain generic drugs do not appear to work as well as the brand name counterparts.

One person recently wrote:

“I feel the need to share my experience with the changes made to my antidepressant, Wellbutrin. I was prescribed Wellbutrin 300, and I’ve taken it for over 12 years. Two weeks ago, my pharmacy sent me a different type of bupropion XL.

“Since starting on this new generic, I have had the worst time ever. I feel so much rage! I am agitated and hate everyone and anything! How can this happen? I feel like I am in an escalating downward spin.

“Today I realized these feelings of rage began when I started taking this new bupropion. I called my doctor to inform her of my reactions and to enlist her assistance. She explained that many people react differently when pharmacies use a different manufacturer to fill prescriptions. I am so grateful that she listened and requested a change back to the original medication.”

Actually An Old Story!

This is not the first time we have heard of such problems with certain generic bupropion products. Starting early in 2007 we began hearing about problems with one particular generic form of bupropion (Budeprion XL 300). Here is a link to that article. https://www.peoplespharmacy.com/2007/04/23/side-effects-of/

We began lobbying the FDA to test this generic form of Wellbutrin. For years we were told there was no problem with the generic formulation. Any reports of side effects or lack of effectiveness were psychosomatic. In other words, they were all in the person’s head. We did not give up, though. We forwarded nasty smelling Budeprion pills that people sent us to the FDA. We kept badgering the FDA to do something. We believed that lives were at stake.

Finally, on October 3, 2012 the FDA announced that it would require the removal of generic Budeprion XL 300 because it was “not therapeutically equivalent to the reference listed drug (RLD, Wellbutrin XL 300 mg.” If you would like to read the saga of this generic drug boondoggle, here is a link.

Other Generic Drug Disasters:

Many generic drug companies abroad have gotten into trouble with the FDA. Most recently, the generic blood pressure pill valsartan was found to be contaminated with a probable carcinogen. The active pharmaceutical ingredient was produced in China. Read more about that debacle here.

If you examine the FDA’s oversight of foreign-made medicines, it leaves a lot to be desired. For one thing, FDA inspectors have to notify the generic drug companies in advance that they are coming. That would be a little like telling a restaurant owner that health department inspectors will be coming by to check things out in six weeks. It’s amazing that many generic drug makers still fail their inspections given such advance notice.

We have also determined that there are flaws in the FDA’s generic drug approval process. Instead of comparing the generic drug absorption hour by hour the agency aggregates the data. We think this completely obscures the process. The best way to see what we mean is by looking at the bioequivalence curves for Budeprion compared to Wellbutrin.

Budeprion 150 versus Wellbutrin XL 150 bioequivalence curves

This is a chart of the first eight hours comparing Budeprion XL 150 to Wellbutrin XL 150. On the left is blood concentration ranging from 0 to 70 ng/ml (nanograms per ml). On the bottom is hours. It does not take a pharmacologist to realize that these curves are quite different. And yet this product remains on the market as bioequivalent even though the 300 mg version was deemed bioinequivalent. The FDA’s system for approving generic drugs confounds us!

What Are Authorized Generic Drugs?

Is there any way to take a generic drug that would offer a good price but still be of high quality? As it turns out, there is. You could seek out authorized generic drugs.

When a generic drug company makes a deal with the brand-name manufacturer to get an exclusive license, that is known as an authorized generic. In many instances, it is made in the same plant and on the same production line as the original brand-name medicine. Sometimes the generic company is a subsidiary of the brand name manufacturer. That is the case with the generic firm Greenstone. It is a subsidiary of Pfizer.

If it is made somewhere else, the generic manufacturer must use the same recipe and the same inactive ingredients. The delivery system must also be the same for an authorized generic.

Unfortunately, many health professionals are not aware of the concept of authorized generic drugs. It may be difficult to get the pharmacy to fill your prescription with an authorized generic even if one is available. Large chain drug companies like to cut deals with specific generic drug manufacturers. Such authorized generics may cost a bit more than other generic products, but they are almost always considerably less than the brand.

Getting Access to Authorized Generic Drugs:

You can learn more about authorized generic drugs and get a list of selected manufacturers in our eGuide to Saving Money on Medicines. It is available at www.PeoplesPharmacy.com in our Health Guide Section.

Authorized Generic Drugs:

 The following list contains the authorized generic drug name followed by the brand name inside the parenthesis followed by the manufacturer inside brackets. With this information your pharmacist should be able to locate the precise authorized generic drug that you seek.

  • Abacavir and Lamivudine  (Epzicom) [Prasco]
  • Abiraterone Tablets (Zytiga) [Patriot]
  • Acitretin (Soriatane) [Prasco]
  • Adapalene and Benzoyl Peroxide Gel (Epiduo) [Prasco]
  • Adapalene Gel (Differin) [Prasco]
  • Alprazolam Tablets (Xanax) [Greenstone]
  • Amlodipine and Atorvastatin (Caduet) [Greenstone]
  • Atazanavir (Reyataz) [Greenstone]
  • Atomoxetine (Strattera) [Prasco]
  • Atorvastatin (Lipitor) [Greenstone]
  • Atovaquone and Proguanil (Malarone) [Prasco]
  • Atovaquone Suspension (Mepron) [Prasco]
  • Augmented Betamethasone Dipropionate (Diprolene) [Prasco]
  • Azithromycin Pak (Zithromax or Z-pak) [Greenstone]
  • Cabergoline (Dostinex) [Greenstone]
  • Calcipotriene Cream (Dovonex) [Prasco]
  • Carbamazepine Extended-Release (Carbatrol) [Prasco]
  • Celecoxib (Celebrex) [Greenstone]
  • Clindamycin Benzoyl Peroxide Topical Gel (Duac) [Prasco]
  • Clindamycin Capsules & Gels (Cleocin) [Greenstone]
  • Clomiphene Tablets (Clomid)
  • Clonidine Extended-Release Tablets (Kapvay) [Prasco]
  • Clotrimazole and Betamethasone Dipropionate Cream (Lotrisone) [Prasco]
  • Colchicine (Colcrys) [Prasco]
  • Colestipol Granules, Tablets (Colestid) [Greenstone]
  • Dactinomycin for Injection (Cosmegen) [Prasco]
  • Dapsone Gel (Aczone) [Greenstone]
  • Desvenlafaxine ER Tablets (Pristiq) [Greenstone]
  • Diclofenac & Misoprostol Tablets (Arthrotec) [Greenstone]
  • Diphenoxylate and Atropine (Lomotil) [Greenstone]
  • Dofetilide (Tikosyn) [Greenstone]
  • Doxazosin (Cardura) [Greenstone]
  • Doxycycline 40 mg Capsules (Oracea) [Prasco]
  • Doxycycline Hyclate Capsules (Vibramycin) [Greenstone]
  • Dutasteride and Tamsulosin (Jalyn) [Prasco]
  • Eletriptan (Relpax) [Greenstone]
  • Eplerenone (Inspra) [Greenstone]
  • Ethosuximide (Zarontin) [Greenstone]
  • Exemestane (Aromasin) [Greenstone]
  • Fluconazole for Oral Suspension (Diflucan) [Greenstone]
  • Fluconazole Tablets (Diflucan) [Greenstone]
  • Fluorometholone Ophthalmic (FML) [Greenstone]
  • Galantamine Capsulres/Tablets (Razadyne) [Patriot]
  • Gabapentin Oral Solution (Neurontin) [Greenstone]
  • Gatifloxacin Ophthalmic Solution (Zymaxid) [Greenstone]
  • Gentamicin Ophthalmic Solution (Genoptic) [Greenstone]
  • Glipizide XL (Glucotrol XL) [Greenstone]
  • Hydrocortisone Tablets (Cortef) [Greenstone]
  • Hydroxychloroquine (Plaquenil) [Prasco]
  • Hydroxyprogesterone Caproate Injection (Makena) [Prasco]
  • Ibuprofen Lysine Injection (NeoProfen) [Prasco]
  • Itraconazole Capsules & Oral Solution (Sporanox) [Patriot]
  • Ketorolax Ophthalmic Solution (Acular LS) [Greenstone]
  • Ketoconazole Shampoo (Nizoral Shampoo) [Patriot]
  • Lamivudine Tablets (HBV) (Epivir-HBV) [Prasco]
  • Lansoprazole, Amoxicillin, Clarithromycin (Prevpac) [Prasco]
  • Lanthanum Carbonate Chewable Tablets (Fosrenol) [Prasco]
  • Latanoprost Ophthalmic Solution (Xalatan) [Greenstone]
  • Levalbuterol HCl Inhalation Solution (Xopenex) [Prasco]
  • Levobunolol Ophthalmic Solution (Betagan) [Greenstone]
  • Linezolid (Zyvox) [Greenstone]
  • Medroxyprogesterone Tablets (Provera) [Greenstone]
  • Mefenamic Acid (Ponstel) [Prasco]
  • Mesalamine delayed-release tablets (Lialda) [Prasco]
  • Methylprednisolone Tablets (Medrol) [Greenstone]
  • Metronidazole Gel, 1% (Metrogel) [Prasco]
  • Metronidazole Topical Lotion (MetroLotion) [Prasco]
  • Miglustat Capsules (Zavesca) [Patriot]
  • Misoprostol Tablets (Cytotec) [Greenstone]
  • Mixed Amphetamine ER & XR (Adderall ER & XR) [Prasco]
  • Montelukast Sodium Oral Granules (Singulair) [Prasco]
  • Nadolol (Corgard) [Greenstone]
  • Nifedipine (Procardia) [Greenstone]
  • Nisoldipine Extended Release  (Sular) [Prasco]
  • Nitroglycerine Sublingual Tablets (Nitrostat) [Greenstone]
  • Omega-3-acid ethyl esters Capsules (Lovaza) [Prasco]
  • Oxaprozin (Daypro) [Greenstone]
  • Oxybutynin Extended Release Tablets (Ditropan XL) [Patriot]
  • Paliperidone Extended Release Tablets (Invega) [Patriot]
  • Phenelzine (Nardil) [Greenstone]
  • Phenoxybenzamine Capsules (Dibenzyline) [Prasco]
  • Phenytoin Infatabs (Infatabs) [Greenstone]
  • Phenytoin Oral Suspension & Tablets (Dilantin) [Greenstone]
  • Pioglitazone and Glimepiride (Duetact) [Prasco]
  • Piroxicam (Feldene) [Greenstone]
  • Polymyxin and Trimethoprim Ophthalmic (Polytrim) [Greenstone]
  • Prasugrel Tablets (Effient) [Prasco]
  • Prazosin (Minipress) [Greenstone]
  • Prednisolone Ophthalmic (Pred Forte) [Greenstone]
  • Prednisolone Sodium Phosphate Disintegrating Tablets (Orapred) [Prasco]
  • Propafenone HCl ER (Rythmol SR) [Prasco]
  • Quinapril & Hydrochlorothiazide (Accuretic) [Greenstone]
  • Rifabutin (Mycobutin) [Greenstone]
  • Risedronate Delayed-Release (Atelvia) [Greenstone]
  • Risedronate Tablets (Actonel) [Greenstone]
  • Risperidone (Risperdal) [Patriot]
  • Sertraline Oral Solution (Zoloft) [Greenstone]
  • Sildenafil (Viagra) [Greenstone]
  • Silver Sulfadiazine Cream (Silvadine) [Greenstone]
  • Sirolimus (Rapamune) [Greenstone]
  • Spironolactone & Hydrochlorothiazide (Aldactazide) [Greenstone]
  • Sucralfate (Carafate) [Greenstone]
  • Sulfacetamide Ophthalmic (Bleph-10) [Greenstone]
  • Sulfasalazine Delayed-Release (Azulfidine EN-Tabs) [Greenstone]
  • Sulfasalazine Tablets (Azulfidine) [Greenstone]
  • Tadalafil Tablets (Cialis) [Prasco]
  • Tazarotene Cream (Tazorac) [Greenstone]
  • Testosterone Gel (Testim) [Prasco]
  • Tolterodine ER Capsules (Detrol LA) [Greenstone]
  • Tolterodine Tablets (Detrol) [Greenstone]
  • Trandolapril Verapamil (Tarka) [Greenstone]
  • Triazolam (Halcion) [Greenstone]
  • Voriconazole (Vfend) [Greenstone]
  • Zileuton ER Tablets (Zyflo CR) [Prasco]
  • Ziprasidone (Geodon) [Greenstone]

Share your Story:

Please tell us your experience with generic drugs. Have you ever tried an authorized generic? Did it make a difference?

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  1. jj
    Virginia
    Reply

    The whole situation is very scary. It is sad that we cannot trust our government to protect us. What is the deal with pharmacists not knowing the difference between an authorized generic and a anda? That simply blows my mind. I can’t believe this is not discussed in college? Also, as far as prices. What is the deal about a “gag” order?

  2. Penelope
    FLorida
    Reply

    Take your problem to your congressman and senator! Ask them to start an investigation into why we’ve let the pharmaceutical manufacturing industry go to China. Why doesn’t the President get on this one?

  3. Annie
    NC
    Reply

    The whole situation is incredibly frustrating. Some generics work better than others, but there’s no way to figure out which manufacturer is best, and in any case the pharmacies appear always to be shopping around for the cheapest, and often worst, formulation, so you’ll get one that works and one that doesn’t. Another fun development: drugs you’ve taken for years are suddenly not on the insurance company’s approved list, and there’s nothing you or your doctor can do. Why is Adderall approved, but not Concerta?

  4. Patrick
    Dallas, TX
    Reply

    Regarding Zoloft;
    I have been told by Greenstone that they no longer make generic sertraline (zoloft).
    It worked great for me and I have been unable to find it anywhere.

  5. BBBob
    Amherst, NY
    Reply

    A dozen years ago, the head pharmacist at our local chain pharmacy told us that their profit margin from many generic drugs was actually much greater while being less expensive for the patient to buy. Additionally, he said that manufacturers of generics are allowed to vary the strength of the active ingredients by up to 20% compared with that of the brand name product while stating the same amount on the label. Without showing showing actual proof of either of these statements, we have no way of knowing whether these claims are accurate, but suspect there may be some truth to them.

  6. Sue
    PA
    Reply

    I was taking Ambien for many years. Then I had to take the generic Zolpidem, and it does not work at all. I spoke to other friends, they complain they cannot sleep with the generic Zolpidem.
    I asked how much a 1 month supply of Ambien would cost, $300.00, compared to $8.00 Zolpidem.
    It’s very frustrating, and it seems like a common problem, the generic drugs are not equal to the name brand.

  7. Cari
    NC
    Reply

    I know that propranalol (Inderal) does not work for me. My BP shot up the moment I went from the name brand to the generic. This seems to be the situation with other generics as well. But, the prices for the name brands are so high that a person would need to be wealthy to take them. I wonder if Carvedilol (Coreg) is even doing anything positive for me. And, you can’t get a Z Pack any longer unless you want to pay a steep price. Who knows what kinds of fillers and binders the generics have in them, and who knows what the manufacturing conditions are like in out of the country pharmaceutical companies. It’s all a crap shoot.

  8. judith
    Glenwood Springs CO
    Reply

    My doctor told me that generic synthroid was okay to take. After two weeks I felt miserable, tired, etc. PLUS the pills would begin to dissolve in my mouth before I could swallow them. It felt like they were made of sand. I called the manufacturer and was told I needed to swallow more water. The response was curt and not apologetic. I have told my doctor never to prescribe another generic medication–after I showed him in a glass of water how quickly the pill dissolved.

  9. PAT
    TN
    Reply

    Why does your list of authorized generic drugs not match up with the FDA Listing of Authorized Generics? I checked several of yours against their list & couldn’t find them & also checked several of theirs against your list & couldn’t find them.

    • Joe Graedon
      Reply

      Because the FDA’s list is virtually impossible to use. It does not list companies that actually distribute authorized generic drugs. This is an incredibly challenging process to untangle. We have looked at lists from companies that sell authorized generic drugs. We only wish that the FDA included that information in its list. Without it, no one can actually determine the source of the authorized generics without going directly to the companies that sell these products.

      • Elle
        Seattle
        Reply

        Joe, this sounds like a service you could provide your readers.

  10. Ralph McGeehan
    NEW JERSEY
    Reply

    I’ve had some problems with generics made by different companies in that they did not work as well as ones from a different manufacturer. The delivery system was different. So I had to go to another company with some difficulty and some waiting to get the generic that I had previously taken. This is something I did not expect, and it’s now worrisome to me that I’m OK with certain manufacturers but not others. So I have to request the same company, and that doesn’t always work.

    This is quite frustrating since I’m paying my RX plan and not getting the medication I need. There has to be some kind of standard for generics. I’ve also run into being charged outrageous amounts for a generic drug. There should be a law in Congress that big pharma MUST cut down on their high pricing for generics. Sometimes it’s at least 200% or more that has been raised every time I get a generic. Could something be done about this?

  11. Clyde
    FL
    Reply

    Age 75, several debilitating diseases. Among others, RA. Taking lortab to ease pain. Lately pharmacists of several pharmacies refuse to fill prescription because they “can’t get enough” or,”We don’t want to be on list.” What about patients with chronic conditions? Since when do pharmacists control what patient can get? Other pharmacies distribute the last garbage of lortab. The tablets fall apart like a sediment. The tablets cause terrible nausea, cramps. They come from obscure small companies in india, China. Lortab is produced here in Fl but pharmacists refuse to order other generics which work. “We can’t. This is what distributor gives us.”

    Please kindly advise how I can get a generic of choice which has worked and doesn’t make me ill. Please, how can I as a patient take action to get my generic?

    Why are seriously ill patients forced to now be house, bed, wheelchair-bound because pharmacists refuse to order the generic of choice, which has worked for years? Why now swallow absolute garbage that doesn’t even seem to contain the substance prescribed and causes illness? I just can’t. It makes me more ill.

    How can I as a seriously ill patient get help? It seems pharmacists now control what I take. I am very upset. Please advise. My doc wrote generic brand Watson on prescription. To no avail. Pharmacist refuses to order.

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