Root Admin Admin 0 Posted February 12, 2018 Root Admin Report Share Posted February 12, 2018 Now there is news that Teva has released a generic version of Soolantra. According to OptumRx, "Teva launched an AB-rated generic version of Galderma’s Soolantra (ivermectin) cream." There was a reported court case about this. According to Lexology Teva prevailed. Law360 wrote "Teva Beats Nestle Unit's Suit Over Rosacea Cream Patents." Scroll down to view an image of this new cream a few posts past this one. Apparently this generic version of Soolantra has been through some hoops with several press releases about this since January 30, 2018. There appears to have been a lot of litigation going on that further complicates this. You can review these press releases below with regard to Perrigo and Sol-Gel. A generic Soolantra is now available. For more information. PDF of the press release downloaded July 5, 2018:Perrigo Announces Tentative FDA Approval For The Generic Version Of Soolantra® Cream, 1% - Jan 30, 2018.pdf Reply to this Topic There is a reply to this topic button somewhere on the device you are reading this post. If you never heard about this topic and you learned about it here first, wouldn't it be a gracious act on your part to show your appreciation for this topic by registering with just your email address and show your appreciation with a post? And if registering is too much to ask, could you post your appreciation for this topic by finding the START NEW TOPIC button in our guest forum where you don't have to register? We know how many have viewed this topic because our forum software shows the number of views. However, most rosaceans don't engage or show their appreciation for our website and the RRDi would simply ask that you show your appreciation, please, simply by a post. Quote Link to post Share on other sites
Root Admin Admin 0 Posted February 25, 2018 Author Root Admin Report Share Posted February 25, 2018 "Bayer AG BAYRY is suing it over a generic rosacea product [Finacea Foam?] after Perrigo filed for Food and Drug Administration approval for it. Bayer makes the branded product, Finacea Foam, which is approved for the raised spots and pimple-like bumps that are symptoms of mild to moderate rosacea." Perrigo shares decline 1% on news of Bayer lawsuit over generic rosacea product, Marketwatch Cision, on Jan 30, 2018, states, "Annual market sales for the last 12 months were approximately $120 million, according to IMS Health."Perrigo Announces Tentative FDA Approval For The Generic Version Of Soolantra® Cream, 1%, Cision Quote Link to post Share on other sites
Root Admin Admin 0 Posted July 7, 2018 Author Root Admin Report Share Posted July 7, 2018 In inquiry on the status of Perrigo's generic ivermectin cream provided a response from Bradley Joseph, VP, Global Investor Relations and Corporate Communications, Perrigo Company, who wrote, "No change in the status of this product. We will announce via press release the launch of this product. Thanks." Quote Link to post Share on other sites
Root Admin Admin 0 Posted February 28, 2019 Author Root Admin Report Share Posted February 28, 2019 Update “Sol-Gel anticipates that building a portfolio of generic product candidates with favorable commercial agreements can supplement its branded pipeline and potentially have a meaningful contribution to the Company’s operating income,” stated Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “This strategy first came to fruition last January when Perrigo received tentative approval from the FDA for ivermectin cream, 1%, developed in collaboration with Sol-Gel. Perrigo was second to file and, as of today, has the only reported tentative approval for ivermectin cream, 1%, and there is no public disclosure of a third filer to the FDA," added Dr. Seri-Levy." Sol-Gel Technologies Announces Sixth Agreement for a Generic Product Candidate with Perrigo, Globe Newswire Update from Sol-Gel Quote Link to post Share on other sites
Root Admin Admin 0 Posted April 19, 2019 Author Root Admin Report Share Posted April 19, 2019 Sol-Gel Technologies LTD is continuing its clinical trial with its generic ivermectin cream and has also released information on Epsolay for papulopustular rosacea, which is the first micro-encapsulated single active benzoyl peroxide (5%) prescription drug. For more information or download here: 0001178913-19-000060.pdf Quote Link to post Share on other sites
Root Admin Admin 0 Posted January 28, 2020 Author Root Admin Report Share Posted January 28, 2020 "A generic version of Soolantra has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Soolantra and have been approved by the FDA: ivermectin cream; topical Manufacturer: TEVA PHARMS USA Approval date: September 13, 2019z" Source: Drugs.com Teva 1% Ivermectin Cream Quote Link to post Share on other sites
Root Admin Admin 0 Posted October 21, 2020 Author Root Admin Report Share Posted October 21, 2020 "Today, Aug. 21, 2019, a Delaware court issued an opinion finding three key patents covering Galderma’s Soolantra acne cream invalid and not infringed by Teva’s generic product....The FDA granted tentative approval to Teva’s generic product in March of this year; because of today’s decision, the FDA is now permitted to grant final approval. Today’s opinion is favorable for Teva, which may now launch its generic product at risk once it receives final approval from the FDA." (TEVA) Soolantra: Delaware Court Finds Galderma Patents Invalid; Teva May Launch Generic Version of Soolantra At Risk Pending FDA Approval, August 21, 2019, Reorg "On January 29, 2020, the Federal Circuit reversed and remanded an August 21, 2019 decision (Galderma v. Teva, 390 F.Supp.3d 582 (2019)) handed down by the United States District Court for the District of Delaware in the patent infringement dispute between Galderma Laboratories and generic manufacturer, Teva Pharmaceuticals, relating to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galderma’s Soolantra® (1% ivermectin cream for topical use) for treating inflammatory lesions of rosacea." Galderma Prevails At The Federal Circuit, Forcing Case Back To The District Court To Consider Teva’s Additional Invalidity Theories, Wolf Track Life Sciences IP Blog, Posted by Gabe McCool on Feb 10, 2020 "The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for its discussion of anticipation and inherency in the context of method of treatment claims. The decision shows that even in the context of anticipation, establishing inherency can be a high burden to carry." Necessity Is The Mother Of Single Reference Anticipation By Inherency, Courtenay C. Brinckerhoff, Foley & Lardner LLP Quote Link to post Share on other sites
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