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Nexium OTC or Prescription Nexium: Singing the Generic Blues as Esomeprazole Magnesium Stays Purple

Last June we wrote about how Americans taking Nexium – AstraZeneca’s multibillion dollar proton pump inhibitor that treats gastro esophageal reflux disease (GERD) – were losing out on savings due to the FDA’s postponement of a generic version in the U.S. market. Well, it looks like they’re going to wait even longer to find generic copies of the Purple Pill at local pharmacies (and the generic versions probably won’t be purple!). Initially, Indian pharmaceutical company Ranbaxy held exclusive marketing approval to sell generic Nexium in the U.S., but they were banned from actually selling it due to poor manufacturing practices. Well, last week the FDA revoked both Ranbaxy’s approval and its marketing exclusivity for generic Nexium. That might be good for the Purple Pill’s profits (say it fast) – but it leaves consumers singing the blues.

Cash paying Americans are left with the following domestic options: Prescription-strength (40 mg), Nexium or Nexium OTC (20 mg). Prescription-strength Nexium will run you about $600 for 60 pills. That’s a ridiculous price. It’s only $70 to get 126 capsules of Nexium OTC! So, can you just buy Nexium OTC instead of prescription-strength Nexium and just take two pills?

You might be able to, but you need to ask your doctor, pharmacist, or other healthcare provider. I asked my local pharmacist if I could just take OTC Nexium instead, and without hesitation she said I could, but that it may not be as effective and that it comes as a tablet rather than a capsule. The OTC version also has different inactive ingredients, I was told, so if you are allergic to any of those, you should stick with the 40 mg version. She suggested OTC Nexium if I couldn’t make a trip to my doctor or if my insurance didn’t cover prescription Nexium. Even if Nexium is covered, it might be a tier 2 or 3 drug, which could result in your co-pay being higher than the OTC cost.

We’d feel remiss in not reminding you that there are a plethora of proton pump inhibitors on the U.S. market, many that come at a much lower price tag.

But if you need to stick with prescription-strength 40 mg Nexium, it is available from international online pharmacies: 60 pills would be about $50, so it’s actually a better deal than Nexium OTC in the U.S. It’s worth noting that just like the OTC 20 mg pill, the 40 mg purple pill is sold as a tablet, not a capsule, in many foreign markets. You can view our comparisons of Nexium prices.

Hopefully we see these delays sorted out, and a generic version of 40 mg Nexium finally come to market in America. Until then, Nexium OTC at your local drugstore or ordering from an international online pharmacy may be your best options to avoid the drug price blues.

 

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Consumers Lose Due to Postponed Generics for Nexium, Diovan, and Valcyte

Americans are used to finding low-cost generic medications about six months to a year after they’re approved by the FDA. Think Lipitor, Plavix and Lexapro, which are all priced about 80% lower as generics.

Unfortunately, patients who had been looking forward to newly-approved generic versions of Nexium, Diovan, or Valcyte will have to keep waiting as a knot of legal and regulatory guidelines delay their U.S. release. The FDA approved Indian drugmaker Ranbaxy’s generic versions of these meds but has banned the plants to be used for their production from exporting products to the U.S., due to findings of substandard manufacturing practices.

You’d think that another drug manufacturer could just make and market the drug, but the U.S. approval system doesn’t allow that. The FDA grants six months of exclusive marketing rights to the company that first gains approval for a generic drug. We wrote about this process two weeks ago in our blog post covering generic Celebrex. Even though Ranbaxy’s plants can’t export generic versions of Nexium, Diovan, and Valcyte to the U.S., it still retains marketing exclusivity in the U.S. market!

This is good news for brand name drug makers and bad news for consumers. Global sales for Nexium, Diovan, and Valcyte totaled $8 billion last year. Delays to generic Diovan have grossed Swedish drugmaker Novartis $100 million a month. Cash-paying Americans, as usual, are hurt most by these shenanigans as they continue to pay high prices for brand-name medication. Taxpayers should also be unhappy, since they are footing the bill for these brand name drugs purchased through programs like Medicare and Medicaid.

There is, however, a bit of good news on the horizon – the European Medicines Agency, an Agency under the European Union that evaluates medicinal products (like the FDA), will reinstate the good manufacturing practices certificate for Ranbaxy’s Toansa plant, which was slated to produce generic Nexium and Diovan. Hopefully, these improvements are good enough for the FDA.

In the meantime, so you’re not held hostage to drug price insanity, you can find these brand medications internationally at amazing discounts. Feel free to compare their prices:

Diovan – save 70%
Valcyte – save 70%
Nexium – save  93%

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Indian Medications Sold at U.S. Pharmacies and Online: What Americans Should Know

Americans may be concerned by recent reports in the media about the safety of medications made in India (e.g., the New York Times article “Medicines in India Set off Safety Worries”). Problems with Indian drugs should be neither overlooked nor overstated. In this post we try to put this into perspective for American consumers who purchase Indian medication at their local pharmacies, whether they are aware it’s from India or not, or directly from an Indian pharmacy by ordering online.

Over the past decade, prescription medicine made in India has been sold in large quantities in U.S. pharmacies. Today, according to the FDA, Indian medications make up about 33% of all prescriptions filled here.  In fact, Walmart’s ability to offer a $4 generic drug program was initially due to importing and selling medicines  from the Indian drug companies Ranbaxy and Cipla. However, last year Ranbaxy was found to be making false claims to the U.S. Food and Drug Administration and exporting medications to the United States that did not comply with FDA’s regulations.  The FDA fined Ranbaxy $500 million and banned importation of its products made in India.

It’s important to note that well-known brand name pharmaceutical companies, based in the U.S. and other rich countries, also have serious manufacturing problems. GlaxoSmithKline was fined $750 million for knowingly selling adulterated prescription medication that ended up in local U.S. pharmacies. In 2010, Eli Lilly was sent a warning letter from the FDA for violations of good manufacturing practices.  Those are two examples of many.

The FDA’s discovery of more problems at Indian manufacturing plants is not necessarily due to new health risks associated with Indian drugs. In the past, the FDA could not afford to conduct regular inspections of many, if not most, foreign drug manufacturing facilities. Greater funding under a new law has enabled more FDA scrutiny of Indian drug companies, which has led to increasing regulatory enforcement by FDA. A major problem is that the Indian counterpart to the FDA, the Central Drug Standard Control Organization, needs to do a better job regulating drug safety. In fact, FDA Commissioner Margaret Hamburg recently travelled to India to engage her counterparts in a plan to improve regulatory oversight of drug manufacturers. We applaud her initiatives with India.

Another issue in India is that some Indian manufacturers make less quality, lower cost medicines for sale to poorer countries and to poorer segments of the population within India. This two-tier system is sad but true.

So where does that leave you as a consumer?

Notwithstanding the greater scrutiny by FDA in India, Indian medications sold to Americans are generally of high quality, whether purchased at a U.S. pharmacy or from a PharmacyChecker-approved online pharmacy dispensing from India.  To be approved within the PharmacyChecker.com program, an Indian pharmacy must only dispense medications manufactured in plants which are 1) approved by FDA or by  other strong regulatory authorities such as those in Canada and the UK; 2) operated by the largest and best Indian drug manufacturers who are known to most consistently sell high quality medication; or 3) approved by Indian regulators and inspected by qualified American personnel to meet FDA standards of Good Manufacturing Practices. In addition, every Indian pharmacy approved by PharmacyChecker.com has been inspected by an American pharmacist with special expertise in international mail-order pharmacy safety, and its pharmacy license has been verified with regulatory authorities in India.

As we’ve written before, international online pharmacies are not just “Canadian pharmacies.” Most of the reputable ones originated in Canada but are now partnered with pharmacies in several countries, including India. Other verified and safe international pharmacies are located in Australia, New Zealand, and the United Kingdom. There are even pharmacies created specifically for international mail-order pharmacy services on island nations. The ones approved in the PharmacyChecker.com Verification Program meet very high standards.

Where you order from should be based on the best information available and we strive to provide it. India has become the top supplier of generic medications worldwide but not all their medications are created equal.

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