Court invalidates patent on J&J’s Zytiga, but …

Here in the US, according to news reports issued late on Friday, a federal court in New Jersey invalidated the last remaining patent held by Johnson & Johnson on their formulation of abiraterone acetate, known as Zytiga, and used in the treatment of castration-resistant forms of prostate cancer.

For a couple of examples of such news reports, see here and here.

In theory, this means that generic formulations of abiraterone acetate should become available as early as October 31. However, Johnson & Jonson has said it is going to appeal this most recent decision, and the U.S. District Court Judge has therefore stated he wants to consider delaying the availability of generic forms of abiraterone acetate until an appeals court rules on the patent. Quite how long this might take is not clear.

The one thing that we can be quite sure about is that Johnson & Johnson will continue to seek to delay access to generic versions of abiraterone acetate for as long as the company can manage. It is known that Zytiga had sales of $1.4 billion in the first 9 months of 2018 in the US alone. Both J&J and its partner BTG plc (the original developer of Zytiga) had been hoping to defer access to generic forms of abiraterone acetate until 2027.

The US Patent Office’s Patent Trial and Appeal Board had also determined that this last remaining patent was invalid earlier this year, and J&J has already appealed that decision.

6 Responses

  1. I have mixed feelings about this situation. Drug companies need a return to invest in research and development but this drug costs the NHS in the UK over £2,000 a month — which means many people who could benefit from its earlier use will not receive it. Most recent studies reported on this site suggest that rather than sequentially supplying treatments whereby prostate cancer regains the initiative and then is treated are much less effective than adjuvant treatment. Abiraterone will not be widely prescribed here until generics bring the price down significantly.

  2. Dear Charles:

    I think we all understand that there is a problematic equation here. Biopharmaceutical companies do indeed need relatively high profit levels from approved medications in order to invest in the development of new drugs. However, just so that you have a complete picture …

    The nominal price for 12 months of treatment with Zytiga here in the US is between about US$101,000 and US$115,000 (i.e., £79,276 to £90,265), which equates to about US$9,000 or £7,064 per month (about 3.5 times the price in the UK).

    Now most people don’t have to pay that price (because they have insurance or they are on Medicare), but what is not transparent to us at all is exactly how much the manufacturer and others are actually being paid, on average, for each tablet of Zytiga that gets taken because of the complex payment and reimbursement systems that are in place in the US, with multiple different groups seeking (and arguably needing) to make a profit along the way (e.g., the manufacturer, the wholesaler, the individual pharmacy or specialty pharmacy, and the actual physician group or hospital that administers the medication).

  3. The company that produces Zytiga offers financial assistance to patients who need help.

  4. Yes. But you only actually get such assistance if you meet some very specific criteria.

  5. Hello.

    This is a belated thank you for your 11/1/18 response re: my question about Zytiga. I have another question.

    I have turned the corner and my Stage IV prostate cancer is no longer responding to standard hormone ablation. I will be offered Zytiga (which is generic now). However, I have a complicated cardiac history and after some googling I am concerned about the cardiac side effects of Zytiga.

    Xtandi is a good choice because it has less effect on the heart. Do you know if I can make a case for using Xtandi? It costs more than Zytiga.


    Charlie Roemer

  6. Dear Charlie:

    The question as to whether Xtandi might be a more appropriate option to treat you with than Zytiga, now that you have progressed on standard androgen deprivation therapy, is one that you really need to discuss with your doctors. I am not a doctor, and I don’t enln enough about your “complicated cardiac history.” What I do know is that all of the new drugs like Zytiga and Zytiga also come with some degree of cardiovascular risk, and the specific risks need to be assessed in the context of the prior medical histroy of each individual patient. So …

    Do insist on a conversation about this with the doctor before anyone simply switches you to Zytiga. It may be the best choice for you, but you are certainly entitled to ask and feel comfortable about this.

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