Teva Ivermectin Cream - Generic Soolantra

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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

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[Admin 0]

"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

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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." 

[Admin 0]

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

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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

[Admin 0]

"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

[Admin 0]

"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