Testosterone Shortage Update: ETAs, Alternatives and Causes

This is an update to two previous posts on the current intramuscular (IM) testosterone shortage:

• Canada’s Testosterone Shortages – Jan 15, 2012
• Testosterone Shortage Update: Sandoz Suspending Production – Feb 20, 2012

ETAs for Testosterone Brands in Canada

1. Pfizer Depo-Testosterone (t. cypionate)

On Feb 22, CanadaPharma.org listed Feb 29, 2012* as the availability date for Pfizer’s Depo-Testosterone. However, by Friday the notice had been removed from the website (along with a notice about Sandoz Testosterone.) I contacted them to find out what this meant but received no response.

On Feb 23, the Saskatchewan Drug Information Services (SDIS) posted an availability date for Pfizer Depo-T of Feb 29, 2012*.

With two reports citing this ETA date there’s good reason to believe that Depo-T will be available shortly.

*UPDATE, 03/01/12: These ETAs were provided by Pfizer and as such don’t necessarily reflect the date that your pharmacy will have Depo-T in stock. Before it gets to you, it has to go from Pfizer to the distributors, then on to pharmacies. This may explain the March 7th ETA date that’s being relayed by some pharmacists.

2. Valeant Delatestryl (t. enanthate)

I’ve heard several people say that their pharmacists told them that Valeant Delatestryl will be back in March or April. I’ve also heard that Delatestryl is expected to be out indefinitely. (It’s possible this is being confused with Sandoz, see below.) I have not located a bulletin with a return to market date for Delatestryl, and there are no updates available on the Theramed or Valeant websites. (Valeant doesn’t list Delatestryl as one of their products, but Theramed still does.)

3. Sandoz Testosterone (t. cypionate)

FridayPM.ca lists an availability date of Dec 30, 2012 for Sandoz Testosterone, however SDIS reports that “all Sandoz injectable products are now on allocation until further notice.”

No bulletins have been posted by Health Canada on the shortages of any of the three brands of injectable testosterone marketed in Canada. I requested that they post an advisory and have received no response.

Testosterone Shortages in the United States

As of Feb 9, 2012, a few of brands of IM testosterone remain off the market in the U.S.:

• Paddock has testosterone cypionate 200 mg/mL 1 mL and 10 mL vials are on intermittent back order due to raw material shortage, and the company is allocating product to wholesalers as supplies are released.
• Teva has temporarily discontinued their testosterone cypionate injection presentations.
• Sandoz discontinued testosterone cypionate 200 mg/mL 1 mL and 10 mL vials in September, 2011.

Available products in the U.S.:

Watson had been unavailable for several months and did not provide a reason for their shortage, but is reportedly now back.

• Testosterone Cypionate intramuscular injection, Watson
  200 mg/mL, 10 mL multidose vial (NDC 00591-3223-79)

Though they remain unavailable in Canada, both Pfizer and Sandoz have IM testosterone on the market south of the border:

• Depo-testosterone intramuscular injection, Pfizer
  100 mg/mL, 10 mL vial (NDC 00009-0347-02)
  200 mg/mL, 1 mL vial (NDC 00009-0417-01)
  200 mg/mL, 10 mL vial (NDC 00009-0417-02)
• NEW – Testosterone Cypionate intramuscular injection, Sandoz
  100 mg/mL, 10 mL multidose vial (NDC 00781-3073-70)

The FDA has no advisories posted for injectable testosterone brands in their list of Current Drug Shortages.

Need Your Prescription Filled? Alternative Sources of Testosterone

“The bottom line for patients is to expect more shortages.” — Dr. Jacalyn Duffin, The Globe and Mail

It looks like we’re at the tail end of this shortage, but with shortages becoming more common the following information may be helpful the next time this happens and you’re caught short:

1. Find a pharmacy that still has T in stock. You’ll need to crack the phone book and call around. You may even have to look outside the area where you live, I did. If you find a source, you’ll have to ask your doctor to call in a new prescription because they can’t be moved pharmacy-to-pharmacy for controlled substances.

If you live on Vancouver Island, Central Drugs in Nanaimo currently has lots of Depo-T in stock. The pharmacist there anticipated the shortage and stocked up. (Thanks for this information, Timmy!)

2. Get injectable testosterone compounded. If you can’t locate a pharmacy with T in stock or wait for Depo-T to return to the shelves, or if you’re allergic to the cottonseed oil in Depo-T, consider getting an injectable testosterone compounded for you. Compounding pharmacies are not uncommon, but those that can make injectable drugs are. Here are a few Canadian compounding pharmacies that can make injectable T:

• Marks Pharmacy, Vancouver, BC 100mg/ml 10ml vial – $70-80 (Doesn’t have materials in stock but believes they can be acquired shortly.)
• People’s Pharmacy, White Rock, BC – 100mg/ml 10ml vial – $90
• Pace Pharmacy, Toronto, ON – T. cypionate, 100mg/ml, 10ml vial – $100
• York Downs Pharmacy, Toronto, ON – 100mg/ml 10ml vial – $46 (Why so much cheaper here?)

(Thanks to K for doing this sleuthing!)

In the U.S., compounded injectable testosterone seems more common. Many American guys I know get their T from Strohecker’s or ApotheCure (who can make your testosterone up with sesame or olive oil instead highly GMO’d cottonseed oil.) Note the price at Strohecker’s too: $52.95 (+ S/H) for 200mg/ml T. cypionate in sesame oil, 10 ml vial.

Why is compounded IM testosterone so much pricier in Canada?

Possible Causes of the Testosterone Shortage

“The causes [of drug shortages] are unknown to most people – patients, pharmacists, and physicians – who are dealing with this problem. Those who do know the causes are reluctant to publicize them.” — canadadrugshortage.com

A “raw materials supply” has been cited as the reason for the testosterone shortage, but there are some holes in this claim.

First, what’s in an injectable testosterone preparation?

• Theramed Delatestryl: Testosterone enanthate, sesame oil, chlorobutanol
• Pfizer Depo-Testosterone and Sandoz Testosterone: Testosterone cypionate, benzyl alcohol, benzyl benzoate, cottonseed oil

Delatestryl went off-market around the time that Theramed sold production rights to Valeant. A raw materials supply issue emerged right at the same time as this change of hands? It’s possible, but how inconvenient for Valeant! It doesn’t sound like they did their due diligence. (I also heard that there were production “hiccups” in moving the manufacturing duties to Valeant but I can’t confirm this.)

Sandoz became unavailable in the U.S. immediately following the FDA crack down in the summer. While there are Novaris/Sandoz plants in the U.S., it’s the Canadian plant that made the U.S. supply of Sandoz T. It didn’t go off-market because of a raw materials supply issue; it looks like it disappeared because of the FDA blocking import of Sandoz T from Canada. (Notice above that a different concentration of Sandoz testosterone is available in the U.S. It’s unclear if this is older stock or if it’s being manufactured by another Novaris/Sandoz plant.)

Here in Canada, Sandoz T was sold until it went out of stock. Because of the FDA warnings heeded earlier this month, all Sandoz injectable products are now on allocation until further notice.

The Pfizer advisory from SDIS states that the reason for their shortage is increased demand because Delatestryl has been unavailable.

So, it’s possible that Delatestryl became unavailable due to a lack of t. enanthate or medical grade sesame oil, but there’s no clear evidence to support this. (Strohecker’s has lots of sesame oil…) Sandoz and Pfizer definitely didn’t go out of stock because of raw material supply issues. They were 1) shut down and 2) caught unprepared.

“Lots of different causes have been mooted. I think somebody knows the answer and is not telling us,” said Dr. Jacalyn Duffin, a hematologist and medical historian at Queen’s University in Kingston, Canada.

But she noted that many of the “missing” drugs are inexpensive generics, and there is widespread speculation that pharmaceutical manufacturers may be choosing to reduce or even discontinue production of less profitable generics in order to boost sales of newer, more expensive brand-name drugs.

“I think there’s more money to be made by selling expensive drugs, so what you want to do is try to kill the cheap ones, your competitors,” she suggested. — metronews.ca

Having read these comments, now consider this: One of the brands of injectable testosterone that has been “temporarily discontinued” in the U.S. is marketed by Teva Pharmaceutical Industries Ltd., an Israeli firm that happens to be the world’s biggest manufacturer of generic drugs. A Teva spokesperson said 2011 was a challenging year but predicted that earnings and sales would rise in 2012, aided by the introduction of new generic drugs that could help its U.S. business recover.

Teva was in the news just last week as shares in BioSante rose dramatically when the FDA approved their new Bio-T-Gel topical T product, which will be marketed by… Teva. The FDA approval was somewhat surprising as there are already five other practically identical testosterone gels on the market in the U.S. (“Realistically, Bio-T-Gel doesn’t stand a chance.”):

• Abbott is the testosterone gel market leader. Worldwide sales of Androgel totaled $875 million in 2011, and the company enjoys a 74% U.S. market share.
• Auxillium Pharmaceuticals (AUXL) has reported $150 million in sales of Testim through the first nine months of 2011, making it the second-largest testosterone replacement gel in the U.S.
• Watson Pharmaceuticals (WPI), Eli Lilly (LLY) and Endo Pharmaceuticals (ENDP), crack $100 million in testosterone gel sales.

The current U.S. market for male testosterone products is estimated at over $1.6 billion, where hypogonadism affects as many as 5 million men.

Now consider Teva’s potential profits on sales of gel compared to injectable testosterone (assuming Bio-T-Gel is priced competitively):

Brand / Preparation	Amount	Approx. Supply	Cost (USD)
Testosterone Cypionate	100 mg/ml 10ml vial	2.5 months	$57.99
AndroGel	30 x 25 mg/2.5 gm packets	1 month	$270.61

(Pricing from DrugBank.ca. I’ve seen U.S. AndroGel pricing as high as $360/month.)

Cha-ching!

Here in Canada, we have two testosterone gels on the market: AndroGel by Abbott and Testim by Auxilium. However, I noticed that a patent related to topical T recently expired in Canada (see patent info and DrugBank link above.) So will we see a new, expensive brand of T gel hit the Canadian market soon… to replace one of the less profitable injectable preparations? We shall see.

Have a tip to share? If you have a reference for Delatestryl’s return to market date, know of pharmacies with injectable testosterone in stock or that can make injectable T, or have related thoughts about these testosterone shortages, please leave your comments below.

Related links:

• Canadian Generic Pharmaceutical Association –  Drug Shortage Advocacy
• Canadian Drug Shortage – A website for information about drug shortages in Canada.

UPDATE 2, 03/01/12: Added Pace Pharmacy in Toronto to the list of compounding pharmacies in Canada that can make IM testosterone preparations.