Generic Oracea in First Quarter 2011 ?


A market analyst report just published speculates that Mylan Inc. may be in a position to market Generic Oracea as soon as the first quarter of 2011. These speculations are based on the successful outcome of a trial set down for December 2010 where Mylan will argue against the 5 patents that Galderma holds for the intellectual property associated with Oracea.

Rosacea News covered Galderma’s legal proceedings against Mylan in March 2009. Mylan has filed an Abbreviated New Drug Application (ANDA) for Doxycycline Delayed-release (DR) Capsules USP, 40 mg. This filing was challenged in court by Galderma.

Today’s article is an opinion piece attributed to Needham & Company and published at, suggesting that if Mylan is successful in their ANDA application, their share price would rise based on their access to the $240m a year Oracea market.

Needham & Company Maintains a ‘Strong Buy’ on Mylan (MYL); Receives Final Approval for Generic Oracea Potentially Setting Up Exclusivity Launch

July 13, 2010 7:29 AM EDT

Needham & Company maintains a ‘Strong Buy’ rating on Mylan Inc. (NYSE:MYL), price target $26.

Needham analyst says, “MYL has received final FDA approval for generic Oracea, a $240.0MM oral formulation of doxycycline marketed by Galderma for the treatment of rosacea.

MYL is first-to-file on Oracea though despite the final approval, immediate launch is precluded per a preliminary injunction granted innovator Galderma tied to litigation on five Orange Book listed patents. With trial scheduled for early December 2010, launch potential appears unlikely before late 1Q11 at the earliest.

We are certain MYL has 180-day statutory exclusivity though less certain the company is alone given possibility second-filer Lupin also filed its ANDA before Galderma listed patents in the Orange Book and certified simultaneously with MYL.

Impax Labs (Nasdaq: IPXL) (Hold-rated) has also filed and was subject to a 30-month stay ending Feb. 2012.”

Some other interesting points suggested by the article

  • Mylan was the first to file to be granted permission for generic Oracea.
  • Lupin and Impax Labs have also filed to have permission to sell generic Oracea.

Whilst all of this is highly speculative, and it is the job of market analysts to offer their opinions based on predicting the future, it is still interesting to see that the market for rosacea treatments is large enough to be fought over.

Rosacea sufferers would benefit from the availability of cheap generic delayed release doxycycline 40mg, and paradoxically also benefit when Galderma earns income from sales of branded Oracea: through the availability of generated R&D dollars.

What do you think ?

Are you being held back by the price of Oracea ? Are you waiting for generic Oracea ?

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

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2 Reader Comments

  1. Ted says:

    I have been using Oracea for two months now and while the results are debatable (I see little change while my dermatologist says he sees some improvement, as he always does), one thing is not debatable- getting my Oracea prescription filled is a major pain. Both times I’ve gone I’ve had a card given to me by my dermatologist that says “pay no more than $25 for Oracea” Walgreens either doesn’t like accepting or has trouble figuring out how to use it, because each time it has taken them about 30 minutes to finally figure it out.

    I guess my question relating to this article is- does “generic” Oracea mean it would be over the counter, or simply that it would be much cheaper?

  2. Hi Ted,

    As Oracea is an antibiotic, any generic versions would also be an antibiotic and require a prescription. With more than one manufacturer you would expect the price to fall considerably.


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