FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose

[dalpat077]

Not sure where to put this but I figured that this is worth mentioning around these parts:

FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose

www.drugs.com

I encourage anybody that's interested in all things pharma. to subscribe to their daily newsletters just by the way. You'd be surprised at some of the alerts that come through on a daily basis e.g. recalls, new FDA approvals, etc. etc. etc.

 

[darvocet21]

Not sure where to put this but I figured that this is worth mentioning around these parts:

FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose

www.drugs.com

I encourage anybody that's interested in all things pharma. to subscribe to their daily newsletters just by the way. You'd be surprised at some of the alerts that come through on a daily basis e.g. recalls, new FDA approvals, etc. etc. etc.

There should be a category big Pharma criminal corruption. How long is naloxone been on the market. How then can FDA issue of an exclusive patent on a life-saving medicine?

 

[dalpat077]

There should be a category big Pharma criminal corruption. How long is naloxone been on the market. How then can FDA issue of an exclusive patent on a life-saving medicine?

Easy there anti-big pharma. Tiger!

The FDA doesn't issue patents. They only approve medications for use.

Here you go:

Adamis Pharmaceuticals Strengthens Patent Portfolio for Its Naloxone Product Candidate

SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) (

www.globenewswire.com

 

[darvocet21]

Easy there anti-big pharma. Tiger!

The FDA doesn't issue patents. They only approve medications for use.

Here you go:

Adamis Pharmaceuticals Strengthens Patent Portfolio for Its Naloxone Product Candidate

SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) (

www.globenewswire.com

Paper tiger argument. Of course the patent office is responsible but FDA approval required. Actually the problem with naloxone is $$$ the spray formula is also on patent and extremely expensive. I used to be a fan of big Pharma. I read the PDR for pleasure. I looked at the pictures in the middle like a centerfold of a p**** mag.

They're making money on both ends of the opioid epidemic

 

[dalpat077]

Paper tiger argument. Of course the patent office is responsible but FDA approval required. Actually the problem with naloxone is $$$ the spray formula is also on patent and extremely expensive. I used to be a fan of big Pharma. I read the PDR for pleasure. I looked at the pictures in the middle like a centerfold of a p**** mag.

They're making money on both ends of the opioid epidemic

Not strictly true re: FDA approval being required in order for a patent to be granted.

And to the best of my knowledge it's one of the reasons why patented pharmaceuticals are so expensive i.e. a company may have developed 10 different pharmaceuticals, have them all patented, but only 1 gets FDA approval. And that 1 has to cover the cost of R&D, patent costs, and all related additional costs for the other 9 that didn't make it through the FDA approval process.

The above being said: I'll concede that there is probably a fair amount of shenanigans involved. I mean think about it: as a business would you go to the time and the trouble and the cost of developing a new pharmaceutical when you know FULL WELL that there is NO chance of obtaining FDA approval? In other words (but not being an expert on the topic nor being a patent attorney): it would make sense if there were already preliminary discussions going on with the FDA during the development phase and prior to the application for a patent.

I'd go so far as to hazard a guess that there's probably plenty of pharmaceuticals and medical devices that are patented but that will never see the light of day because they cannot, or will never, obtain FDA approval.

Mind you: look at Theranos. She had everything patented yet the FDA only approved ONE of the tests after the fact.

And there's plenty of patents registered that will never see the light of day because they were specifically applied for and obtained in order to block competition (that too happened with Theranos).

By the way:

By PDR I assume you're talking about the below?

PDR.Net | Fully Searchable Drug Information

Nice. New resource for me!

 

[darvocet21]

The book was better

 

[darvocet21]

Patents are always being issued irrespective of what stage of IND

 

[dalpat077]

The book was better

Oh. Alright. I saw mention of it on the site. Thanks.

Edit:

But for one tiny problem as noted on the site:

"PDR Books

PDR is no longer publishing printed books. However, you can access our drug information in an easier format than ever using 'mobilePDR'. Click here to learn more"

 

[darvocet21]

Sure.

 

[darvocet21]

Not strictly true re: FDA approval being required in order for a patent to be granted.

And to the best of my knowledge it's one of the reasons why patented pharmaceuticals are so expensive i.e. a company may have developed 10 different pharmaceuticals, have them all patented, but only 1 gets FDA approval. And that 1 has to cover the cost of R&D, patent costs, and all related additional costs for the other 9 that didn't make it through the FDA approval process.

The above being said: I'll concede that there is probably a fair amount of shenanigans involved. I mean think about it: as a business would you go to the time and the trouble and the cost of developing a new pharmaceutical when you know FULL WELL that there is NO chance of obtaining FDA approval? In other words (but not being an expert on the topic nor being a patent attorney): it would make sense if there were already preliminary discussions going on with the FDA during the development phase and prior to the application for a patent.

You're not wrong but it's even simpler than that.

 

[darvocet21]

When Dr. Gottlieb appears on every major News Network is he appearing in his capacity as former FDA commissioner (2017- 2019) a member of the Board of Directors of Pfizer or both?

 

[darvocet21]

It's all one big racket.

 

[darvocet21]

My family is ready to disown me. Accuse me of being a conspiracy theorist. There's no conspiracy it's all right out in the open. Hiding in plain sight.

Here's the gentleman who's the current chairman of the board of Pfizer:

 

[darvocet21]

I was wrong. The man above is chairman of the board of Coca-Cola.

Dr. Bourla (a Veterinarian) is current Pfizer chairman and CEO.

Anyway you have a good night.

 

[dalpat077]

I was wrong. The man above is chairman of the board of Coca-Cola.

Well I'm sure he appreciated the short-lived executive promotion!

Dr. Bourla (a Veterinarian) is current Pfizer chairman and CEO.

Well he's obviously well qualified and the right man for the job!

"He opposes government interference in pharmaceutical pricing, which he believes would hamper spending on development of new drugs."

Albert Bourla - Wikipedia

en.wikipedia.org

Get a load of this i.e. not a bad club to belong to!

Member CEOs of Leading U.S. Companies | Business Roundtable

Business Roundtable members description

www.businessroundtable.org

 

[plumbus-nine]

Weren't naloxone kits available for quite some time now? So the news is that they're new patented?

 

[dalpat077]

Weren't naloxone kits available for quite some time now? So the news is that they're new patented?

From what I gather (although I've not spent too much time on this) the patent is based on the below delivery device (already patented by them some time ago) as well as the strength or naloxone dosage.

SYMJEPI® (epinephrine) Injection | Official Website

Learn about SYMJEPI, the compact and reliable epinephrine delivery option for treating allergic emergencies. Please see ISI and full PI on this website.

www.symjepi.com

But, you may say, there is already a similar device on the market (also patented) called Evzio (and a generic)? Well apparently not. Not anymore as of last year. Simply put: it was just no longer economically viable to continue producing these things (well: they were not making enough profit to put it another way).

Evzio auto-injector and its generic equivalent have been discontinued from the market

workcompauto.optum.com

And maybe something important to be aware of:

"EVZIO (naloxone hydrochloride - solution;intramuscular, subcutaneous)
Manufacturer: KALEO INC
Approval date: April 3, 2014
Strength(s): 0.4MG/0.4ML (0.4MG/0.4ML) (discontinued)

Manufacturer: KALEO INC
Approval date: October 19, 2016
Strength(s): 2MG/0.4ML (2MG/0.4ML) (discontinued)

All of the above formulations have been discontinued.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Evzio. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication."

My point being: not a good time to find out that your Evzio is a fake!

Generic Evzio Availability - Drugs.com

Generic drug availability, manufacturer information, and patent status on Evzio

www.drugs.com

Also and from what I gather: Kaleo (Evzio®) and Adamis (Zimhi®) had a go at each other (legally speaking) in 2019. Not sure what the outcome was.

kaleo, Inc. v. Adamis Pharmaceuticals Corp. drug patent litigation (1:19-cv-00917)

Patent Lawsuit history for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (1:19-cv-00917)

www.drugpatentwatch.com

Anyway. Whatever the case and outcome. One thing obviously led to another and you now have Zimhi® from Adamis! Well maybe not yet i.e. according to Adamis' website they'll only begin marketing in the US in 2022.

 

[darvocet21]

From what I gather (although I've not spent too much time on this) the patent is based on the below delivery device (already patented by them some time ago) as well as the strength or naloxone dosage.

SYMJEPI® (epinephrine) Injection | Official Website

Learn about SYMJEPI, the compact and reliable epinephrine delivery option for treating allergic emergencies. Please see ISI and full PI on this website.

www.symjepi.com

But, you may say, there is already a similar device on the market (also patented) called Evzio (and a generic)? Well apparently not. Not anymore as of last year. Simply put: it was just no longer economically viable to continue producing these things (well: they were not making enough profit to put it another way).

Evzio auto-injector and its generic equivalent have been discontinued from the market

workcompauto.optum.com

And maybe something important to be aware of:

"EVZIO (naloxone hydrochloride - solution;intramuscular, subcutaneous)
Manufacturer: KALEO INC
Approval date: April 3, 2014
Strength(s): 0.4MG/0.4ML (0.4MG/0.4ML) (discontinued)

Manufacturer: KALEO INC
Approval date: October 19, 2016
Strength(s): 2MG/0.4ML (2MG/0.4ML) (discontinued)

All of the above formulations have been discontinued.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Evzio. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication."

My point being: not a good time to find out that your Evzio is a fake!

Generic Evzio Availability - Drugs.com

Generic drug availability, manufacturer information, and patent status on Evzio

www.drugs.com

Also and from what I gather: Kaleo (Evzio®) and Adamis (Zimhi®) had a go at each other (legally speaking) in 2019. Not sure what the outcome was.

kaleo, Inc. v. Adamis Pharmaceuticals Corp. drug patent litigation (1:19-cv-00917)

Patent Lawsuit history for kaleo, Inc. v. Adamis Pharmaceuticals Corp. (1:19-cv-00917)

www.drugpatentwatch.com

Anyway. Whatever the case and outcome. One thing obviously led to another and you now have Zimhi® from Adamis! Well maybe not yet i.e. according to Adamis' website they'll only begin marketing in the US in 2022.

It's an essential medicine. Every country should have it widely available and affordable. Which it was until it started to be needed

 

[dalpat077]

It's an essential medicine. Every country should have it widely available and affordable. Which it was until it started to be needed

Well here's an article on this. Caveat being this is, after all, the Internet i.e. I don't know the site or the organization or the reporter. But I have spent some time on this and a lot of the stuff appears to be factually correct if cross referenced to other sites especially when it comes to the initial cost of Evzio® auto-injectors and what transpired after they were first made available (initially at a whopping price of $4 100 USD for a 2 pack).

The Price of Saving a Life: Naloxone's Cost Barrier in the US

Why, amid a crisis of overdose deaths, is naloxone more expensive and less accessible in the US than elsewhere?

filtermag.org

Here's a little interesting factoid that provides an answer to a question posed above somewhere:

"Under FDA patent law, Narcan is a “combination device”—both a drug and device packaged together. The cheap cost and multiple generic offerings of the actual compound within, the naloxone, become irrelevant in the face of this designation."

Going back a little in time here i.e. to July 2021.

The US Faces a Naloxone Shortage at the Worst Possible Time

The buyer's club that's the nation's biggest community distributor is hit by a Pfizer shortage. The crisis exposes structural fragility.

filtermag.org

 

[darvocet21]

Thanks I'll read it