The end of market exclusivity for an OTC switch typically signals the start of private label competition, but for Oxytrol for Women the only marketplace change is an addition to the label warnings for the overactive bladder product.

The dominant OTC private labeler, Perrigo Co. PLC, has eyed launching a generic since FDA approved the 3.9mg oxybutynin transdermal patch, now marketed by Allergan PLC, as a first-in-class nonprescription product in 2013. Currently, though, Perrigo says Oxytrol for Women is "not a big product" and instead is talking about other prescription OAB products that could be moved to OTC.

And Allergan has control of Oxytrol for Women only because the initial OTC licensee for the product, Merck & Co. Inc., sold its consumer business to Bayer AG, but after less than a year as owner Bayer cut the brand from its offerings. Bayer later made and distributed the product for Allergen for the final five months of 2015 before its license expired at the end of the year and Allergen regained ownership.

Meanwhile, reports about consumers experiencing confusion while using oxybutynin drugs led FDA to require that products containing the ingredient add a label warning. FDA began with Rx product label changes and in August 2015 asked Bayer to add "confusion" to the label warning language.

Bayer submitted a “changes being effected” supplemental new drug application in September. According to FDA's March 3 response, the updated warning will state: “Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you.”

In a statement, FDA's Center for Drug Evaluation and Research said "products containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported."

CDER added that the change to OTC Drug Facts Label for Oxytrol for Women "was made to ensure consistency between the Prescribing Information and Drug Facts Label as well as to communicate this risk to consumers in consumer-friendly language."

The FDA letter also approved Bayer's request to change Oxytrol for Women labeling to indicate ownership by Bayer, rather than Merck & Co., although Bayer no longer is marketing the product.

"Bayer is in the process of re-labeling all of the former Merck Consumer Care Inc. products marketed in the US to reflect the Bayer name," said a Bayer Healthcare spokeswoman.

From Pioneer To Paused Distribution

During an earnings briefing in February 2015, Bayer Chief Financial Officer Johannes Dietsch said "some of Merck consumer care new product launches in the US in 2014 were not successful … and more specifically amongst them, one product called Oxytrol, which is now discontinued."

Bayer's spokeswoman said from mid-August through Dec. 31 the German firm manufactured and distributed the product for Allergan.

Bayer's license to market Oxytrol for Women expired at the end of 2015 and Allergan regained ownership.

Merck & Co. launched Oxytrol for Women in the US in September 2013 as the first OTC treatment for women suffering from overactive bladder, marking the first-ever nonprescription sales of an oxybutynin-containing drug worldwide.

According to FDA's Orange Book, market exclusivity for Oxytrol for Women expired on Jan. 25. While the opening of a door to compete with an OTC switch, particularly a first-in-class product, typically will spur immediate generic product launches, the end of Oxytrol for Women exclusivity is not filling retail shelves with competing products.

OTC drug marketing experts predicted that Oxytrol for Women's success would depend partly on Merck & Co. overcoming some of the target population’s likely hesitancy to make behavioral changes linked to its efficacy. It was heralded as a potential blueprint for future switches indicated for chronic conditions and carrying label recommendations for behavioral changes Also see "Oxytrol OTC Success Depends On Driving Behavioral Changes" - Pink Sheet, 25 October, 2013..

However, Oxytrol for Women has not pioneered a blockbuster trail for potential novel switches.

It is not the first switch, or even first-in-class nonprescription product not to meet sales expectations. GlaxoSmithKline PLC in 2007 launched alli (orlistat 30mg) as the only OTC drug approved for a weight loss indication, but within two years the product's sales were trailing the firm's expectations.

Glaxo has put alli on the block, but while it has divested numerous other consumer brands, it has not found a buyer. Additionally, alli was recalled in the US and Puerto Rico from March 2014 through February 2015, when it was returned in tamper-proof packaging, after Glaxo warned consumers that some packages of the product may not include the correct drug Also see "Alli Return In U.S. Fattens Glaxo’s Consumer Outlook" - Pink Sheet, 25 February, 2015.

Perrigo Eyes 'Large Category'

At a March 8 investor conference, Perrigo CEO Joseph Papa made clear that the Dublin-based firm is looking at other Rx overactive bladder products as eventual OTC private label opportunities. "What's important about that category is it's a very large category," he said.

Oxytrol for Women "is not a big product, but what's important about it is that, when a product goes from prescription to OTC, what the FDA is essentially saying is that that category can be safely self-diagnosed by a consumer," Papa said.

Perrigo is following other products in the category – Detrol and Detrol LA tolterodine tartrate and Ditropan and Ditropan XL oxybutynin chloride regular and extended release tablets – "as potential candidates for switch. Can't guarantee any of them are going to switch, but certainly, we need to be ready for that potential eventuality," he added.

Additionally, Perrigo has bigger immediate plans for private label versions of other switches. The firm is shipping a generic of Glaxo's Flonase Allergy Relief OTC intranasal corticosteroid, but Glaxo is attempting to delays sales of the product by alleging the trademark and trade dress for Perrigo's product too closely resembles its brand Also see "Perrigo's 'Inversion' Of Flonase Trademark Cuts Too Close For Glaxo's Market Share Comfort" - Pink Sheet, 4 March, 2016..

Glaxo said it distributed more than $330m in Flonase Allergy Relief (fluticasone propionate/0.05mg spray) in 2015, its first year available after FDA approved a switch proposal for the second-in-category product in July 2014.

The first intranasal corticosteroid switch, Sanofi's Nasacort Allergy 24HR (triamcinolone acetonide/0.055mg spray), and the third and most recent, Rhinocort Allergy Spray (budesonide/0.032mg spray) marketed by McNeil Consumer Healthcare under license from AstraZeneca PLC, also are on Perrigo's private label radar.

"We think that's an important part of potential future switches in the category," Papa said at the March 9 investor conference.

He also noted Galderma Labs Inc.'s supplemental NDA for first-in-class OTC adapalene gel 0.1%. FDA has scheduled a Nonprescription Drugs Advisory Committee meeting April 15 to discuss the proposed switch of Differin for use by consumers 12 and older to treat acne ([A#05160222011]).

"If that product switches over the counter, that could have certain implications on future products moving over the counter in the area of acne. So, we look forward to understanding what happens, in terms of what's the FDA decision on that question," Papa said.

Dublin-based Allergan launched Rx Oxytrol in 2003 and expanded its OAB footprint in 2013 when it acquired Actavis, which marketed brands including Enablex (darifenacin). Actavis gained Enablex when it acquired Warner Chilcott PLC in 2012 ([A#05140210013]).

Oxytrol will have still another owner as Pfizer Inc. has made a $160bn offer for Allergen in a deal the firms expect will close in the second half of 2016. However, Pfizer long has weighed divesting its consumer products business and, given Oxytrol for Women's disappointing sales history, gaining the product probably would not sway the firm against making the move ([A#05150803009]).

Oxytrol For Women Exclusivity Ends Not With Competition, But Label Warning Change

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