Generic Oracea – sadly just not going to happen


A recent ruling from a Delaware Federal judge has confirmed that Galderma’s patent protection covering Oracea is secure, and confirming that generic Oracea is just not going to happen.

This most recent ruling found that Amneal Pharmaceuticals’s attempt to create a generic version of the once-daily low dose doxycycline treatment infringes 5 of Galderma’s US patents.

There has been some doubt about whether the patents claimed by Galderma to protect Oracea will continue to offer protection against pharmaceutical companies producing their own low-dose doxycycline variants, but Judge Leonard Stark has laid the issue to rest.

Bad News for Rosacea Sufferers

This is bad news for rosacea sufferers, especially those who do not have comprehensive medical insurance. For those without prescription insurance, Oracea can certainly feel too be too expensive.

Commentary in 2013 suggested that Oracea will enjoy patent protection to around 2027.

Oracea vs. 50mg a day of doxycyline

There is an ongoing debate in the rosaea community as to whether Oracea offers a significant benefit when compared to 50mg once a day of doxycyline. A convincing answer is likely to be hard to come by, but read Is Oracea different to 50mg a day of Doxycycline ? for more information.

Law 360 Report

Galderma Wins On 5 Patents In Generic Oracea Suit

August 28, 2018

Galderma Laboratories L.P. et al v. Amneal Pharmaceuticals LLC et al

Law360 (August 28, 2018, 5:55 PM EDT) — Amneal Pharmaceuticals LLC’s proposed generic version of Galderma Laboratories LP’s flagship rosacea drug Oracea infringes five of Galderma’s patents, a Delaware federal judge ruled on Monday.

Although U.S. District Judge Leonard Stark’s opinion explaining the reasoning for his ruling is still under seal, his order on Monday found that Amneal’s abbreviated new drug application, or ANDA, for an oral antibiotic medication meant to treat the skin condition rosacea infringes Galderma’s U.S. Patent Nos. 8,206,740; 8,394,405; 8,470,364; 8,603,506; and 9,241,946.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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6 Reader Comments

  1. Susan says:

    I am taking a time-release doxycycline-hyclate. It is supposed to be similar to Dory. I understand not all doxycycline-by late is time-released. Has anyone taken the time-release DH? If so, was it successful? Thank you.

  2. Susan says:

    Meant to say, similar to Dory.

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  4. “This crap almost killed me ”

    “This did nothing for me. It might have been a coincidence but within a week of taking it, I had the weirdest breakout like I’ve never had before, or since. I tried it for a month and quit. I don’t like the thought of putting antibiotics into my body on an ongoing basis so I’m trying topicals ”

    “Can’t afford oracea,insurance don’t cover it”

    “Cost is the main difference between generic and brand name prescription drugs. Sad news for the consumer who must pay more.”

    “That is good news. Generics are NOT created equal. Thank you, Galderma!”

  5. Matt says:

    It’s a shame – in Germany Oracea costs through our insurance system just 5€ each package.
    I took it for about 1 year and changed simultaneously my diet.
    As long as I stay to my strict diet I’m pretty much “healed”- without any symptoms beside a little more rose colored faced than some peer people.
    I can highly recommend to anyone to stick to your diet and combine it with Oracea if available…Since one year I don’t take the drug anymore and it’s still fine 🙂

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