doctor in a lab coat with a handful of pills

People have become suspicious of the quality of generic drugs. Is there a way to benefit from the lower cost of these copycat medicines without sacrificing effectiveness?

What are Authorized Generic Drugs?

Authorized generics may be a solution to the dilemma of mistrust. Many physicians and patients are unaware that this option exists. The brand name manufacturer makes a deal with a specific generic company to supply its drug directly or provides the generic maker with exact instructions on how to duplicate the brand name product.

Although the FDA says that all generic drugs are identical to the brand name, that is not accurate if by identical they mean exactly the same. Generic drug companies can use different excipients (the compounds that give the pill color, strength and texture). The generic manufacturer may also have to come up with a completely different drug delivery system.

No one else has access to the precise process of manufacture or the origins of both the active and so-called inactive ingredients. The delivery system (the way the brand name drug releases its active ingredients) may remain under patent by the originator company. An authorized generic is theoretically made on the same production line with the same release technology or in a facility that is allowed to use the process exactly as it was developed by the brand name company.

The Celebrex (Celecoxib) Example:

We recently heard from a reader about one particular authorized generic drug:

“You wrote about someone whose insurance refused to pay for Celebrex and was switched to the generic celecoxib. The person had begun to experience swollen joints and the other symptoms Celebrex treats.

“I had the same reaction when I got switched but had read in your column about others with the same problem. I talked to my pharmacist, who said it was the most common complaint he heard but that there was a solution.

“He said to ask specifically for celecoxib made by Greenstone. It is identical to Celebrex and is manufactured by the same company. Because it is a generic, insurance will pay for it and most pharmacies will order it for you every month. (Allow a couple of extra days to get it filled.)

“Within a week I was able to use my hands again. They had gotten so bad I could not even grip my steering wheel. Now I call in my script a few days early so they can order the Greenstone celecoxib and I’m back to doing the things I enjoy. I hope this information helps other readers as much as your column has helped me.”

The generic manufacturer Greenstone is a subsidiary of the drug giant Pfizer. It is hardly any wonder that Pfizer, maker of Celebrex, would provide its own company the right to market an authorized generic.

The FDA’s Confusing Position on Authorized Generic Drugs:

The FDA may have mixed feelings about authorized generics. That is because the agency asserts that all FDA-approved generic drugs are identical to their brand name counterparts. And yet the FDA has a web page devoted to authorized generic drugs. Sadly, it does not tell you the  company that is actually making the specific authorized generic drug.

Despite FDA reassurances, the American public has reason to be concerned. According to Reuters, the FDA has barred 44 Indian pharmaceutical manufacturing facilities from exporting medications to the U.S. since 2011. Most of these products were generic drugs.

These companies are responsible for a significant proportion of the generic drugs taken by Americans. Companies such as Aurobindo, Dr. Reddy’s Laboratories, Polydrug, Ranbaxy, Sun Pharmaceutical and Wockhardt have all received FDA warnings about quality control.

We have received thousands of complaints about generic drugs over the last decade. Readers of this column have reported troubles with anti-seizure drugs, antidepressants such as bupropion, heart medicines like metoprolol and medications for attention deficit disorder.

Anyone with a complaint about a generic drug should report the problem directly to the FDA with the name of the manufacturer. The FDA website is: www.FDA.gov/MedWatch. We have updated our article about how to Report A Generic Drug Problem which you may find helpful. The FDA does NOT make it easy even though it keeps telling us that it wants consumer complaints. Review this article to learn how to overcome the roadblocks to reporting generic drug problems.

How To Access Authorized Generic Drugs

Until the FDA solves its generic drug monitoring problem, patients may wish to ask their pharmacist for an authorized generic. Do not assume your pharmacist will even know what an authorized generic drug actually is. You may need to print this article and take it with you to the pharmacy. When such an alternative exists, it may be worth paying a bit more for the extra reassurance such a designation provides.

We are in the process of compiling a list of authorized generic drugs. Prasco sells a number of authorized generic drugs for brands such as:

  • Bactroban Cream (mupirocin Calcium Cream, 2%)
  • Dovonex Ointment (calcipotriene 0.005%)
  • Evista (Raloxifene)
  • Lotrisone Cream (clotrimazole and betamethasone dipropionate)
  • Lovaza (omega-3-acid ethyl esters)
  • MetroGel (metronidazole topical gel)
  • Plaquenil (hydroxychloroquine sulfate)
  • Remeron (mirtazapine)
  • Singulair (montelukast Sodium)
  • Vancocin (vancomycin)

Greenstone also sells a number of authorized generics. As already mentioned, Greenstone’s celecoxib should be identical to Celebrex. Other companies that sell some authorized generic drugs include Par Pharmaceuticals and Patriot Pharmaceuticals. If you have concerns about the quality of your generic drug, ask your pharmacist to obtain an authorized generic if one is available.

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  1. Pamela
    Florida
    Reply

    Pam. Florida. July 19, 2018
    Celebrex was a miracle for me. I could walk without pain and not ache endlessly from my shoulders to my ankles. When I had to change to a generic due to price, I returned almost immediately to constant pain.

    The generic Celecoxib was made by Apotex and was totally worthless. I get no relief from this medication whatsoever. Any solutions? My pharmacy’s say they receive whatever brand their store chain deem the best price at the time. ( Publix & Target)

  2. Spenderella
    Dallas, TX
    Reply

    Ever since I saw this article, I’ve been running the mouse maze that Big Pharma has in place should you want to find and purchase an authorized generic. I asked my Kroger Pharmacy a few months back about ordering it for me and the technician had a “deer in the headlights” look on her face and said she would ask the pharmacist. When I checked back, the pharmacist said Kroger wouldn’t order it because it cost more than what the insurance company would pay them for it.

    I contacted an independent pharmacy about it and basically got handed off to an underling who was supposed to “research” the issue and get back to me. Think they called me back? Nope. I don’t remember the young man’s name and I don’t trade in that part of town so I haven’t been back.

    I’ve tried two different manufacturers of generic “equivalents” for Cymbalta and neither are worth the trip to the store. Thankfully, the brand name showed up finally from Eli Lilly after four months of waiting because my income (or lack of it) qualifies me to get for free. I don’t know what happened at their Lilly Cares program but to make someone wait for meds for five months is just plain disgraceful. That’s what sent me on my quest for an authorized generic in the first place.

  3. Paula
    PA, USA
    Reply

    Greenstone – is the distribution center in New Jersey – it does not make drugs – these drugs are made in India.

    My doctor ordered Zithromax, and twice now the pharmacy has given me a non-working antibiotic drug, aythromycin, from India. Finally my doctor (for a upper respirtory infection) told the drugstore that there should be no generic brand – but only the brand Zithromax. The pharmacy stated it would take three days to order the Zithromax (I live two hours from Philadelphia, where the drug is made.).

    Three days later the prescription Zithromax came to the pharmacy – the pharmacy person called me and asked if I wanted the Zithromax ,as the copay was $30.00. The co-pay for the useless drug, aythromycin from India, was $7.00. The aythromycin never works to get rid of sore throats or any upper respiratory symptoms ever!!! I think our insurance carrier is in cahoots with the drug store company.

    Please read the article on the internet, “Medicines made in India set off safety worries.” at http://www.nytimes.com. More than causing worries, the article points out that people have died from these fly and filth-infested places where the drugs are made. Plus the generic is not the same as the original antibiotic. Zithromax has a patent on the contents.

    Please have someone stop giving us generic drugs from India and China. We deserve drugs made in the USA.

  4. Daneille
    Seattle
    Reply

    I’m confused, I went on the FDA site and looked under Celebrex, and it listed G.D. Searle as the NDA, not Greenstone. I was going to ask my pharmacist to order this, but now am not sure after reading the FDA listing… maybe I’m reading it wrong?
    thanks.

  5. Virginia
    Lula, GA
    Reply

    I would love to work with my local, independent pharmacist, but we get our drug coverage through ExpressScripts. There is absolutely no way to communicate with their real pharmacist, only technicians- and I know more than they do as an RN. They have quit putting the manufacturer’s name on our bottles since we all complained about so many Ranbaxy drugs being bad. Obtaining drugs is a morass we all have to slog through since most of us are not independently wealthy!

  6. Steve
    Kansas
    Reply

    This is a very interesting article. I have a couple of questions:
    Are there any Authorized Generics for Percocet (oxycodone?) There are hundreds of chronic pain patients who do not obtain relief from generics.
    Are there any studies to validate the benefits of Authorized Generics?
    It’s easy to see why the FDA is challenging Authorized Generics since generics are supposed to have”therapeutic equivalence” with the Brand.

  7. Tom
    Dallas
    Reply

    Thanks for this information. Speaking of drugs, are there any Canadian Pharmacies that sell the brand drug for Imitrex stat(the pen), or Topamax tabs? BCBS of Texas is putting the wood to us on “the member pays the difference” clause if you don’t take the brand. Running about $400 per month on each drug.

    There is no authorized generic for Topamax. I have a call into Glaxo on the Imitrex. Thanks!

  8. Penelope
    Florida
    Reply

    Is there an authorized generic for Namenda (memantine)?

  9. Rosy
    NY
    Reply

    I meant to say the companies that make them.

  10. Rosy
    NY
    Reply

    Why won’t the FDA show the authorized generic pharmaceutical companies? How can we protect our health if this information is unavailable to us? Also, you mention that even the pharmacist may not know what an authorized generic is, how is that possible? What good is that? So we are stuck taking drugs that either don’t work or cause a lot of side effects and basically, no one really cares. This is disgraceful beyond belief. When will someone make a list of authorized generics and the companies that make?

  11. Art
    Richmond, VA
    Reply

    Thanks for keeping this subject in the news… It’s outrageous that those foreign made generics are allowed to be sold. I have two still in my cabinet that I will now report to the FDA. One generic of Flomax and the other a statin. Both hit me at once causing me to be dizzy or anxious… never took another one. I can’t afford the brand names.

  12. ann
    newport news
    Reply

    please advise!

  13. ann
    newport news
    Reply

    I am taking Multaq 400 mg x2 daily. It is such an expensive drug, there are 3 generic drugs out there but my cardiologist does not recommend them for me. I am 82 years old with a dual lead pacemaker to manage my afib. Can you explain please?

    • HelenM
      Modesto
      Reply

      Ann, your cardiologist does not seem to trust the generics. I would suggest printing out this article and taking it to him; perhaps there is an authorized generic available for you. If he says his staff cannot take the time for this, you may have to research it for yourself on the internet. An expesnsive name brand will push you into the donut hole faster, especially if you take other meds. It would be very much to your advantage, financially, if you can switch to an authoried generic. Good luck!

    • Pat
      Ohio
      Reply

      Those medications are not generics, they are ALTERNATIVES to Multaq. Drug manufacturers are given a certain amount of time for exclusivity (before generics drugs can be available) to recoup the costs of developing the drug. Currently, there is no generic for Multaq. I’m not certain, but through my research, it looks like that time for Multaq make be running out, so maybe we can hope for a less cost equivalent soon!

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