What Are Authorized Generic Drugs and Are They Better?

You’ve heard of generic drugs, right? They are supposed to be chemical copycats of brand name medicines. But that’s a misnomer. Generic drugs are approximations of the original brand name medicine. They are reverse engineered to get as close as possible to the innovator’s product. Only authorized generic drugs are the same as the brand name. Why does it matter?

When Generic Drugs Don’t Work It’s Dangerous!

Most physicians and pharmacists trust the Food and Drug Administration to ensure that generic drugs are the same as their brand name counterparts. That’s not always the case. We have been collecting stories from patients for over two decades. Many are heart breaking. You can read about our adventures with the FDA over the antidepressant Wellbutrin XL 300 and generic drug failures at this link.

An endocrinologist reveals problems with generic hydrocortisone:

Q. As an endocrinologist, I treat patients who have adrenal insufficiency. They cannot make their own cortisol and rely on daily replacement with the synthetic cortisol, oral hydrocortisone.

Recently many patients have reported that the different generic forms of hydrocortisone (brand name Cortef) are not equally effective. Cortef is the brand name made by Pfizer.

One patient in this situation felt like a new person, and her labs improved to show it, after switching from one generic to the other. Differences in the content of hydrocortisone, absorption or pharmacokinetics could put patients at risk because this drug has a very narrow therapeutic window. Too little puts patients at risk of adrenal crisis and death, while too much puts them at risk for long-term side effects including weight gain, diabetes, heart disease, and osteoporosis.

I have not seen anything about this problem with generic hydrocortisone and hope you have some recommendations.

A. Cortef (oral hydrocortisone) was first approved by the FDA in 1952. When the adrenal gland does not make enough cortisol (Addison’s disease), the hormone must be replaced. President John F. Kennedy suffered from this condition.

We have been concerned about generic drug quality for more than 20 years. Both patients and health professionals have related problems with a variety of generic formulations.

According to GoodRx, the brand name Cortef costs over $300 for 90 tablets (20 mg). Generic hydrocortisone tablets would be anywhere from $99 to $114 for the same number of pills. Using a GoodRx coupon would bring the cost down to anywhere from about $30 to $86 depending upon the pharmacy. Patients could purchase brand name Cortef from a legitimate Canadian drugstore for about $80. Of course insurance companies will not pay for medicines purchased from an online Canadian pharmacy.

There is an authorized generic (AG) form of hydrocortisone from Greenstone in the US. It is far less expensive than brand name Cortef. It should be identical to the brand name.

To learn more about AG drugs and how to access affordable brand name drugs from Canada, your patients may wish to read our eGuide to Saving Money on Medicines. This online resource can be found under the Health eGuides tab.

Brand Name Drug Companies Keep Secrets:

Here is something I’ll bet you don’t know. Brand name manufacturers don’t have to reveal the formulation of their original medicines. The FDA classifies such information as proprietary. I suspect that most physicians, pharmacists and nurses don’t realize that Big Pharma does not have to disclose its secrets.

The Coca-Cola Secret:

Consider Coca-Cola Original. Other companies can make generic colas. But the makers of Coke do not share their recipe. They do tell you that the ingredients are:

• CARBONATED WATER
• HIGH FRUCTOSE CORN SYRUP
• CARAMEL COLOR
• PHOSPHORIC ACID
• NATURAL FLAVORS
• CAFFEINE

What they do not tell you are the proportions of those ingredients, what the natural flavors are or how they actually make Coke. The original flavorings in the recipe were formulated over 125 years ago. They are supposedly a deep, dark secret and are kept in a bank vault in Atlanta. You can buy colas at a reduced price, but you realize you are not getting Coca-Cola Original.

Special Sauce:

Brand name drug companies keep their formulas and manufacturing processes to themselves too. Think of it a bit like MacDonald’s Big Mac secret special sauce. You know the jingle:

“Two all-beef patties, special sauce, lettuce, cheese, pickles, onions on a sesame seed bun.”

Anyone can put two beef patties together with lettuce, cheese, pickles and onions. Sesame seed buns are easy to get too. But that special sauce gives MacDonald’s Big Macs an edge.

Authorized Generic Drugs vs. Unauthorized Generics:

Brand Names:

Let’s distinguish between brand name medicines, generic drugs and authorized generic drugs. When a pharmaceutical company develops a new medicine it patents the active pharmaceutical ingredient (API). That’s the chemical compound that exerts the actual effect. But the company can also patent the formulation itself. That includes all the so-called inactive ingredients and the way they are all put together with the API. That recipe is the special sauce.

Generic Drugs:

When the patent expires on the brand name drug that may only apply to the active pharmaceutical ingredient. The special sauce remains proprietary. The FDA does not require the brand name company to divulge its secrets. That’s why the generic manufacturer has to reverse engineer the drug from the ground up.

Authorized Generic Drugs:

When a brand name company loses its patent on a successful medication it is met with chemical copycats. The price is often dramatically lower. In order to maintain some market share, the brand name manufacturer may license its product to another company. In other words, it divulges the secret special sauce formula to another manufacturer.

In some cases the brand name company may continue to make the pills on its own production line and sell the authorized generic drugs to a different distributor. It may remove the brand name from the pill even though it is identical to the original formula.

FDA’s Definition of Authorized Generic Drugs:

“The term ‘authorized generic’ drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand company’s permission.”

Saving Money, Maintaining Quality with Authorized Generic Drugs:

People go to outlet malls because they can often save anywhere from 25 to 65 percent (Consumer Reports, Dec. 9, 2018). The average discount, according to CR, is 38 percent. The appeal is brand name quality at a lower price. One reader pointed out, though, that some stores at outlet malls may not be selling high-quality merchandise. He said:

“I’m told that the merchandize available in such sources is NOT always the same as in the manufacturer’s own, branded, main-line stores with their brand name on them. Maybe even made in the same — mostly overseas — factories, but with lower quality materials , fewer stitches in the seams, and such cost-cutters.”

Here is what the Consumer Reports article found, however:

“The good news is that we found very few seconds, irregulars, or returned items when we shopped at outlet malls recently.”

Most people don’t realize that they can get a similar value for their prescription medicines if they seek authorized generic drugs (AGs). This option is rarely mentioned by pharmacists, physicians or insurance companies, but it can represent huge savings for brand-name quality.

Methylphenidate (Concerta):

 One reader shared this story about the authorized generic for Concerta:

“Thank you for writing about authorized generic drugs. I know this topic too well, as both my teenage son and I have ADD/ADHD respectively.

“I have spent months battling with pharmacies to get authorized generic methylphenidate for each of us. The new Patriot brand that uses the OROS delivery system is a true authorized generic, but it is difficult to find.”

The Concerta brand of methylphenidate comes from Janssen Pharmaceuticals, a subsidiary of the Johnson & Johnson drug company. This special erxtended-release formulation utilizes OROS technology (osmotic-controlled release oral delivery system). The goal of such formulations is to provide a gradual and sustained blood level of the active medication.

According to GoodRx, the price of brand name Concerta averages around $500 a month. The authorized generic (AG) from Patriot Pharmaceuticals is identical to the brand name and should be far more affordable. Getting your pharmacy to stock the Patriot AG of methylphenidate may take some arm-wrestling, though.

Atorvastatin AG:

The savings can be substantial. For example, The Costco Member Prescription Program sells brand name Lipitor (atorvastatin). The cost for 90 pills (20 mg) is $1,600. Other pharmacies charge over $1,800 for the same number of tablets. The brand name manufacturer, Pfizer, has an AG agreement with Greenstone/Viatris. When we checked awhile back the identical 90 atorvastatin pills cost under $30.. That is a dramatic discount for the same exact brand name medicine.

How does that compare to other generic atorvastatin? GoodRx lists atorvastatin from the generic drug manufacturers for 90 pills anywhere from $13 to $41. That is with the GoodRx coupon. The difference is that the authorized generic atorvastatin is identical to brand name Lipitor.

Why Care About Authorized Generic Drugs?

Why should anyone care about seeking out authorized generic medications? For the last year, the FDA has been unable to conduct inspections on generic drug makers overseas because of COVID-19. There were questions about quality even before the pandemic began.

Some readers have found a standard generic may not work as well as the brand. For example, Sandy reported:

“I have been on Zoloft (sertraline) since 2000 and was doing fine until it went generic. My physician told me the FDA allows some variability in the generic. He also told me the binders may release the medication at different rates.

“When I discovered Greenstone sold an authorized generic version of sertraline, everything changed. As soon as my pharmacy ordered them, I felt fine again.”

The trouble with generic drugs is that many of the raw ingredients are now made in China without a lot of FDA oversight. Finished pills are often manufactured in India, Thailand, Slovakia, Brazil, Mexico and goodness knows where else.

We have questions about FDA monitoring. That’s why authorized generic drugs intrigue us. Sadly, many health professionals have no idea what they are. You will find a comprehensive list of authorized generic drugs in this article.

Why Is It So Hard To Get Authorized Generic Drugs?

Q. I want to share my experience trying to purchase an “authorized generic” drug. Our doctor did not know what that phrase meant, nor did any of the pharmacists we talked to.

I found online the label information for the authorized generic and supplied that to CVS. CVS ordered the drug using the NDC code, but that was over a month ago and it is still not in stock.

Walgreen could not find the NDC code in their computer. In the meantime, we had to go ahead and buy the brand-name drug–over $500 for a 30-day supply. Why is this so difficult?

A. Physicians, pharmacists and other health professionals may not always know about authorized generic drugs. That may be in part because the generic drug industry, pharmacies and the FDA have promoted the idea that generic drugs in general are just as good as their brand name equivalents.

That’s why patients may need to take the lead by showing their prescriber or dispenser an article in JAMA Internal Medicine (online, Jan. 25, 2021). This may help you recruit your health care provider as an ally in your quest to balance quality and affordability.

Readers Complain About Regular Generic Drugs:

Jen in Colorado has had generic drug problems:

“I used to be a staunch believer in generics, but that was before I had to take so many medications. I have rheumatoid arthritis and Addison’s disease, and I could open my own pharmacy.

“I too, have experienced severe problems and side effects with generic antidepressants, including lack of efficacy. I have actually gone without an antidepressant for years because my insurance does not want to cover brand name drugs in this class without an act of God.

“I have also run into problems switching between generic manufacturers of prednisone and hypertension medications. When will the FDA force generic manufactures to engage in some sort of trial or research that demonstrates how these drugs compare both to the original, as well as to each other?”

Susie in Indiana had problems with generic Celebrex:

“I just got the generic of Celebrex and thought it would work like the original drug that I used 4 years ago for my back and knee pain. Back then I got instant relief.

“I currently have knee pain and was prescribed the generic. It’s junk, garbage. My knee hurts so badly.

“As of today I went back on Advil, which helps a bit, but not great. I was so looking for much more relief, but the generic just doesn’t cut it. It just doesn’t touch the ache. Once I take it I don’t take anything else for fear of mixing meds. This was a complete waste of money. Hopefully the FDA will recognize it’s not working.”

Marie in Windsor Heights, Iowa also had generic Celebrex problems:

“My insurance plan requires generic substitutes. I couldn’t get the brand Celebrex regardless of my Dr. calling and filing an appeal.

“Taking the generic initially didn’t cause problems but then my mail-order drug company used another manufacturer. I have lupus. The generic celecoxib caused a flare to the point I could barely walk.

“I struggled to get the brand, and finally ordered from Canada. In the USA Celebrex was $1,300.00 for 180 tabs. Canada was $420.00 for 200 tabs. Can’t wait to feel better.”

Joey in New York found generic celecoxib unhelpful but praises authorized generic drugs.

“There is no question that regular generic Celebrex does not work as well. The Greenstone authorized generic is identical to the name brand by Pfizer.

“You can take all the other generic makers of celecoxib and put them in the trash. The real stuff is formulated in a way that delivers the therapeutic dose in the correct manner. The other versions use different ingredients and may only provide 80% of the actual drug, but it’s more the formulation than the amount of drug. That’s what Pfizer put into the R & D and the others just copied but could not make it exactly like Pfizer did.”

Learn More about Authorized Generic Drugs:

We have been surprised to learn that many pharmacists have no idea what an authorized generic is. Physicians are even less familiar with this term. There is no easy place to learn whether your generic drug is available as an authorized generic and who the manufacturer is. We have done our best to create such a list below:

Authorized Generic Drugs

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

One problem is that authorized generic drugs sometimes move from one distributor to another and keeping up with this game of musical chairs can be challenging. We cannot promise that this list is perfect, but it is the best we could manage. Getting a pharmacy to order authorized generic drugs can be a daunting project, though. That’s because buyers for pharmacy chains often seek the lowest price they can find and authorized generic drugs can cost a bit more than “regular” generic drugs. Independent pharmacists may have a greater ability to accommodate you.

• Abacavir and Lamivudine  (Epzicom) [Prasco]
• Acarbose (Precose) [Alvogen]
• Acetazolamide ER (Diamox Sequels) [Teva]
• Acitretin (Soriatane) [Prasco]
• Acyclovir (Zovirax oral suspension) [Mylan]
• Acyclovir (Zovirax cream) [Teva]
• Acyclovir (Zovirax ointment) [Actavis/Teva]
• Adapalene and Benzoyl Peroxide Gel (Epiduo) [Prasco]
• Adapalene Gel (Differin) [Prasco]
• Albendazole (Albenza) [Lineage/Impax G]
• Albuterol (Ventolin HFA) [Prasco]
• Albuterol (Proventil HFA) [Par]
• Aliskiren (Tekturna) [Prasco]
• Alogliptin (Nesina) [Perrigo]
• Alogliptin/Metformin (Kazano) [Perrigo]
• Alosetron (Lotronex) [Actavis/Teva]
• Alprazolam (Xanax) [Greenstone/Viatris]
• Alprazolam XR (Xanax XR) [Greenstone/Viatris]
• Amlodipine (Norvasc) [Greenstone/Viatris]
• Amlodipine and Atorvastatin (Caduet) [Prasco]
• Amlodipine and Benazepril (Lotrel) [Sandoz]
• Amlodipine-valsartan (Exforge) [Sandoz]
• Amoxicillin-clavulanate ER (Augmentin XR) [Dr.Reddy’s]
• Amphetamine (Adzenys ER suspension) [Prasco]
• Amphetamine mixed salts (Adderall XR) [Prasco]
• Armodafinil (Nuvigil) [Sandoz]
• Atazanavir (Reyataz) [Greenstone/Viatris]
• Atomoxetine (Strattera) [Prasco]
• Atorvastatin (Lipitor) [Greenstone/Viatris]
• Atovaquone and Proguanil (Malarone) [Prasco]
• Atovaquone Suspension (Mepron) [Prasco]
• Augmented Betamethasone Dipropionate (Diprolene) [Prasco]
• Azelaic acid (Finacea) [Sandoz]
• Azithromycin Single Dose Packets (Zithromax) [Greenstone/Viatris]
• Benazepril + HCTZ (Lotensin HCT) [Perrigo]
• Benzonatate (Tessalon Pearls) [Greenstone]
• Betamethasone (Diprolene ointment) [Prasco]
• Butalbital/Aspirin/Caffeine (Fiorinal) [Actavis/Teva]
• Butalbital/Codeine Compound (Fiorinal + Codeine) [Actavis/Teva]
• Cabergoline (Dostinex) [Greenstone/Viatris]
• Calcipotriene Cream (Dovonex) [Prasco]
• Calcitonin-Salmon (Miacalcin) [Sandoz]
• Candasartan (Atacand) [Par]
• Carbamazepine Extended-Release (Carbatrol) [Prasco]
• Carbamazepine Extended-Release (Tegretol XR) [Sandoz]
• Carisoprodol (Soma) [Wallace]
• Carvedilol ER (Coreg CR) [Apotex]
• Celecoxib (Celebrex) [Greenstone/Viatris]
• Cephalexin (Keflex) [Fera]
• Ciprofloxacin (Cipro) [Barr]
• Clindamycin Benzoyl Peroxide Topical Gel (Duac) [Prasco]
• Clindamycin Capsules & Gels (Cleocin) [Greenstone/Viatris]
• Clonidine Extended-Release Tablets (Kapvay) [Prasco]
• Clotrimazole and Betamethasone Dipropionate Cream (Lotrisone) [Prasco]
• Colchicine (Colcrys) [Prasco]
• Colestipol Granules, Tablets (Colestid) [Greenstone/Viatris]
• Dactinomycin for Injection (Cosmegen) [Prasco]
• Dapsone Gel (Aczone) [Greenstone/Viatris]
• Desvenlafaxine ER Tablets (Pristiq) [Greenstone/Viatris]
• Dextroamphetamine sulfate (Dexedrine) [Impax/Amneal]
• Dextroamphetamine ER (Adderall ER) [Prasco]
• Dexmethylphenidate (Focalin) [Sandoz]
• Diclofenac Epolamine (Flector) [Teva]
• Diclofenac & Misoprostol Tablets (Arthrotec) [Greenstone/Viatris]
• Diltiazem CD (Cardizem CD) [Oceanside]
• Diphenoxylate and Atropine (Lomotil) [Greenstone/Viatris]
• Dofetilide (Tikosyn) [Greenstone/Viatris]
• Donepezil (Aricept)  [Greenstone/Viatris]
• Doxazosin (Cardura) [Greenstone/Viatris]
• Doxycycline 40 mg Capsules (Oracea) [Prasco]
• Doxycycline Hyclate Capsules (Vibramycin) [Greenstone/Viatris]
• Dutasteride and Tamsulosin (Jalyn) [Prasco]
• Eletriptan (Relpax) [Greenstone/Viatris]
• Eplerenone (Inspra) [Greenstone/Viatris]
• Ethosuximide (Zarontin) [Greenstone/Viatris]
• Exemestane (Aromasin) [Greenstone/Viatris]
• Fluconazole for Oral Suspension (Diflucan) [Greenstone/Viatris]
• Fluconazole Tablets (Diflucan) [Greenstone/Viatris]
• Fluorometholone Ophthalmic (FML) [Greenstone/Viatris]
• Gabapentin Oral Solution (Neurontin) [Greenstone/Viatris]
• Gatifloxacin Ophthalmic Solution (Zymaxid) [Greenstone/Viatris]
• Gentamicin Ophthalmic Solution (Genoptic) [Greenstone/Viatris]
• Glipizide XL (Glucotrol XL) [Greenstone/Viatris]
• Hydrocortisone Tablets (Cortef) [Greenstone/Viatris]
• Hydroxychloroquine (Plaquenil) [Prasco]
• Hydroxyprogesterone Caproate Injection (Makena) [Prasco]
• Ibuprofen Lysine Injection (NeoProfen) [Prasco]
• Ketorolax Ophthalmic Solution (Acular LS) [Greenstone/Viatris]
• Lamivudine Tablets (HBV) (Epivir-HBV) [Prasco]
• Lansoprazole, Amoxicillin, Clarithromycin (Prevpac) [Prasco]
• Lanthanum Carbonate Chewable Tablets (Fosrenol) [Prasco]
• Latanoprost Ophthalmic Solution (Xalatan) [Greenstone/Viatris]
• Levalbuterol HCl Inhalation Solution (Xopenex) [Prasco]
• Levobunolol Ophthalmic Solution (Betagan) [Greenstone/Viatris]
• Linezolid (Zyvox) [Greenstone/Viatris]
• Medroxyprogesterone Tablets (Provera) [Greenstone/Viatris]
• Mefenamic Acid (Ponstel) [Prasco]
• Mesalamine delayed-release tablets (Lialda) [Prasco]
• Methylprednisolone Tablets (Medrol) [Greenstone/Viatris]
• Metoprolol tablets (Toprol XL) [Lannett]
• Metronidazole Gel, 1% (Metrogel) [Prasco]
• Metronidazole Topical Lotion (MetroLotion) [Prasco]
• Misoprostol Tablets (Cytotec) [Greenstone/Viatris]
• Mixed Amphetamine ER & XR (Adderall ER & XR) [Prasco]
• Montelukast Sodium Oral Granules (Singulair) [Prasco]
• Nadolol (Corgard) [Greenstone/Viatris]
• Nifedipine (Procardia) [Greenstone/Viatris]
• Nisoldipine Extended Release  (Sular) [Prasco]
• Nitroglycerine Sublingual Tablets (Nitrostat) [Greenstone/Viatris]
• Omega-3-acid ethyl esters Capsules (Lovaza) [Prasco]
• Oxaprozin (Daypro) [Greenstone/Viatris]
• Phenelzine (Nardil) [Greenstone/Viatris]
• Phenoxybenzamine Capsules (Dibenzyline) [Prasco]
• Phenytoin Infatabs (Infatabs) [Greenstone/Viatris]
• Phenytoin Oral Suspension & Tablets (Dilantin) [Greenstone/Viatris]
• Pioglitazone and Glimepiride (Duetact) [Prasco]
• Piroxicam (Feldene) [Greenstone/Viatris]
• Polymyxin and Trimethoprim Ophthalmic (Polytrim) [Greenstone/Viatris]
• Prasugrel Tablets (Effient) [Prasco]
• Prazosin (Minipress) [Greenstone/Viatris]
• Prednisolone Ophthalmic (Pred Forte) [Greenstone/Viatris]
• Prednisolone Sodium Phosphate Disintegrating Tablets (Orapred) [Prasco]
• Propafenone HCl ER (Rythmol SR) [Prasco]
• Quinapril & Hydrochlorothiazide (Accuretic) [Greenstone/Viatris]
• Rifabutin (Mycobutin) [Greenstone/Viatris]
• Risedronate Delayed-Release (Atelvia) [Greenstone/Viatris]
• Risedronate Tablets (Actonel) [Greenstone/Viatris]
• Sertraline Oral Solution (Zoloft) [Greenstone/Viatris]
• Sildenafil (Viagra) [Greenstone/Viatris]
• Silver Sulfadiazine Cream (Silvadine) [Greenstone/Viatris]
• Sirolimus (Rapamune) [Greenstone/Viatris]
• Spironolactone & Hydrochlorothiazide (Aldactazide) [Greenstone/Viatris]
• Sucralfate (Carafate) [Greenstone/Viatris]
• Sulfacetamide Ophthalmic (Bleph-10) [Greenstone/Viatris]
• Sulfasalazine Delayed-Release (Azulfidine EN-Tabs) [Greenstone/Viatris]
• Sulfasalazine Tablets (Azulfidine) [Greenstone/Viatris]
• Tadalafil Tablets (Cialis) [Prasco]
• Tazarotene Cream (Tazorac) [Greenstone/Viatris]
• Testosterone Gel (Testim) [Prasco]
• Tolterodine ER Capsules (Detrol LA) [Greenstone/Viatris]
• Tolterodine Tablets (Detrol) [Greenstone/Viatris]
• Trandolapril Verapamil (Tarka) [Greenstone/Viatris]
• Triazolam (Halcion) [Greenstone/Viatris]
• Voriconazole (Vfend) [Greenstone/Viatris]
• Zileuton ER Tablets (Zyflo CR) [Prasco]
• Ziprasidone (Geodon) [Greenstone/Viatris]

More About Authorized Generics and Online Canadian Pharmacies:

You can learn about problems that have occurred with generic drugs and more details on authorized generics in our Guide to Saving Money on Medicines.

You cannot trust all advertised Canadian online pharmacies. There are mail-order pharmacies that may be located half way around the world that pretend to be located in Canada. We have done our best to vet some of the more reliable Canadian online pharmacies. This online resource is available at www.PeoplesPharmacy.com.

What’s an NDC Anyway?

The NDC (National Drug Code) is a unique number to identify every drug sold in the U.S. The FDA maintains an online directory of all NDC identifiers.

Share your own experience with generic drugs. Have you ever purchased authorized generic drugs? How did they work? We’d love to hear your story below in the comment section.