In contrast to the ongoing disputes over generic Oracea, the makers of the low-dose minocycline Solodyn, Medicis have entered into a joint development and sales agreement with Lupin Pharmaceuticals.
Solodyn is a form of Minocycline, a member of the tetracycline famaily, available in 8 strengths, prescribed based primarily on your weight.
Solodyn tablets are available in 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg.
Officially, Soldyn is indicated to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris.
Medicis are known to rosacea sufferers as the manufacturers of Ziana and Plexion.
The Agreement
This agreement allows Medicis and Lupin to set aside the legal wrangling over the patents that are said to protect Solodyn, and allow Lupin to progressively manufacture Generic Solodyn. Additionally the two companies will work together to further develop the market for generic versions of Solodyn.
Lupin vs. Galderma
We also know from other court filings that Lupin Pharmaceuticals, along with Mylan and Impax Laboratories are all fighting for the right to manufacture Generic Oracea. Galderma is engaged in an extended dispute, using the Oracea Patents to attempt to stop others from manufacturing a cheaper version of Oracea.
This is Good News
This sort of agreement is good news for those who would like access to Solodyn, but at a more affordable price.
Rosacea Sufferers can only hope that Galderma would consider a similar agreement over Oracea. Too much to expect? Maybe so.
Medicis and Lupin Settle Solodyn Infringement Dispute; Agree to Drug Development Collaboration
Medicis has entered into multiple agreements with Lupin over the acne drug Solodyn, allowing the generic drugmaker to enter the market prior to the expiration of Medicis’ patents.
In a separate agreement, Medicis agreed to join Lupin in a drug development collaboration worth an initial $20 million to the generic company.
Medicis claimed Lupin infringed U.S. Patent Nos. 5,908,838 and 7,790,705 by seeking to manufacture a generic version of Solodyn before the patents expire. The ‘838 patent covers a slow-dissolving form of tetracycline, a class of oral antibiotics commonly used to treat acne. When tetracycline dissolves too rapidly after being swallowed, the incidence and severity of side effects such as vertigo, dizziness, and blurred vision can increase. The ‘705 patent relates to methods of administering the dosages.
On July 21, Judge J. Frederick Motz signed off on a consent judgment that permanently enjoined Lupin from selling generic Solodyn except under the terms of a separate licensing agreement. The licensing agreement allows Lupin to sell a generic version of Solodyn in various different doses prior to the expiration of the patents. Under the agreement, Lupin can move ahead with 45mg, 90mg, and 135-milligram doses in November, the 65mg and 115milligram doses in February 2018, and the 55mg, 80mg, and 105milligram doses in February 2019.
Under certain conditions that were not disclosed, Lupin could begin making the generic earlier.
