GlaxoSmithKline PLC’s Flonase Allergy Relief is in stores as the first OTC fluticasone nasal spray with market exclusivity limited to an indication for eye-related allergy relief, allowing private label launches with a label carve-out before the exclusivity expires.

FDA included a label carve-out in Glaxo’s market exclusivity for Flonase Allergy Relief through July 23, 2017. The exclusivity granted in November 2014 is limited to an indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies,” according to the agency’s Orange Book.

GlaxoSmithKline's Flonase Allergy Relief is in stores as the first OTC fluticasone nasal spray.

Image courtesy of GlaxoSmithKline PLC

FDA in July 2014 approved a new drug application from GSK to switch the fluticasone propionate 50 mcg metered spray with indications for temporary relief of the symptoms of hay fever or upper respiratory allergies. OTC Flonase is available in 60- and 120-spray containers Also see "Flonase Switch Approved, Branded Nasal Allergy Spray Market Will Grow In 2015" - Pink Sheet, 24 July, 2014..

While the label carve-out allows private label competitors to launch their versions during the three years, Glaxo has exclusivity for promoting the product for relief of all nasal and eye-related allergy symptoms.

Food and drug attorneys, commenting generally about Rx or OTC new drug application approvals with exclusivity including label carve-outs, say firms interested in marketing generics can submit abbreviated NDAs after labeling for a new drug is published. ANDAs can be approved to allow marketing during the exclusivity period with a label carve-out; firms marketing those products can ask FDA to change labels to match the branded product after the exclusivity period expires.

FDA employs label carve-outs far more often in decisions on abbreviated new drug applications for Rx than for OTC products. The agency made use of a label carve-out in its February 2014 decision to allow marketing of private label versions of Teva Pharmaceutical Industries Ltd.’s Plan B One-Step emergency contraceptive, but without labeling indicating for use by females under 17 ([A#05140303009]).

While the carved-out labeling meant levonorgestrel 1.5 mg ANDAs would not be approved for any of the age groups covered in Teva’s actual use study, for which the firm garnered exclusivity, FDA declined to require private label versions to include additional labeling on the principal display panel “that reinforces the age limit” or to impose a proof-of-age requirement for purchases.

FDA Center for Drug Evaluation and Research officials who evaluate NDAs for nonprescription or Rx drugs do not determine whether the product will launch with periods of market exclusivity allowed under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act. An exclusivity board, in a separate decision, considers an exclusivity summary prepared by CDER staff in determining whether clinical trials conducted for an NDA support granting exclusivity ([A#05140811008]).

Clinical Data Supported Carve-Out

During Flonase Allergy Relief’s exclusivity period, potential store brand fluticasone propionate 50 mcg sprays would be indicated for temporary relief of nasal congestion, runny and/or itchy nose and sneezing as symptoms of hay fever or other upper respiratory allergies.

The exclusivity “does apply specifically to a new indication, which is around the OTC use for the eye symptoms,” said Amardeep Kahlon, Rx-to-OTC switch director for GSK’s Parsippany, N.J.-based Consumer Healthcare North America division.

Kahlon said the exclusivity decision was based on clinical data Glaxo submitted for the switch NDA that showed the product’s safety and efficacy in an OTC setting to help consumers with eye allergy symptoms.

“Through the research we’ve done, we know that there are a significant number of allergy sufferers that are still not getting the relief they need,” he said in an interview.

Perrigo Co. PLCnoted Feb. 5 it is unsure when a private label version can be launched and are not including a fluticasone propionate 50 mcg spray in their 2015 plans.

“We have initiated regulatory pathways with the objective of receiving the necessary approvals to ensure we are able to launch a store brand OTC fluticasone product as soon as possible,” a Perrigo spokesman said in a statement.

Perrigo plans to launch its generic of Sanofi’s OTC Nasacort 24HR (triamcinolone nasal spray) in the first half of 2015.

Although Nasacort Allergy 24HR is a first-in-class switch, FDA did not grant Sanofi marketing exclusivity because the NDA for the switch did not require clinical trials – the criteria for eligibility for three-year exclusivity under the Hatch-Waxman Act. However, the French pharma filed a lawsuit that kept the labeling of the product under wraps between the October 2013 approval and the February 2014 launch by Sanofi’s U.S. consumer health care subsidiary Chattem Inc., delaying the filing of ANDAs for generics Also see "Martek/Mead Agreement" - Pink Sheet, 22 May, 2006..

Ads Emphasize All Symptoms

Advertising for OTC Flonase will emphasize the product’s use for all allergy symptoms, unlike other OTC nasal spray brands or the product’s private label competitors.

“Eyes are important as well as other symptoms to people who suffer allergies,” Kahlon said, adding that half of the 50 million consumers with hay fever or upper respiratory allergies “are not getting the full symptom relief that they need right now.”

“What we’re trying to do is make sure consumers are aware of the symptom relief they can get from us and how we’re different.”

Flonase Allergy Relief advertising has yet to launch other than on the product’s website. The campaign will include TV ads and “a lot of online, digital, social as well,” Kahlon said.

“We really want to make sure we drive as much awareness as possible to the fact that ultimately something that was really well-prescribed and -trusted by health care professionals is now available over the counter.”

Glaxo expects consumers already using the brand’s Rx product will account for most OTC Flonase users, but others using different OTC or Rx brands also could help drive sales.

“It gets back to a lot of people still not getting the relief they need with currently available therapies,” Kahlon added.

Flonase Allergy Relief Exclusivity Sliced Up By Label Carve-Out

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