Pfizer Expects OTC Nexium Will Launch With Market Exclusivity

Marketing exclusivity would be a key advantage as Nexium 24HR enters a crowded market of branded and private label OTC competitors. The NDA for Nexium 24HR included clinical data, Pfizer says, but whether FDA allowed Hatch-Waxman Act exclusivity for the product is not yet determined.

Pfizer Inc. expects to launch OTC proton pump inhibitor Nexium 24HR with three-year market exclusivity, following FDA’s approval on March 28 of a new drug application for the 20 mg esomeprazole product.

Nexium 24HR is indicated for frequent heartburn, defined as happening two or more days a week, in consumers age 18 years and older. Pfizer said it expects to have the product in drug, grocery, mass merchandiser and club stores nationwide this year and available online.

Pfizer says clinical trials were included in the NDA for Nexium 24HR, although the product will enter a crowded market or branded and private label OTC PPIs, which Procter & Gamble Co. pioneered in 2004 with Prilosec OTC.

FDA did not require clinical trials in switch NDAs for the other PPI brands that followed Prilosec OTC into the space. Under the Hatch-Waxman Act, an FDA requirement for clinical trials in a switch NDA is significant because the product is then eligible for market exclusivity if approved for OTC sale. Other branded OTC switches quickly face generic competition as private label firms have abbreviated NDAs ready to submit to FDA.

Pfizer has not said specifically whether FDA required clinical trials for the NDA or whether the agency has informed the firm that the product can launch with market exclusivity.

However, a Pfizer spokeswoman said on March 29: “We expect the clinical data we've obtained to provide a three-year exclusivity period.”

Agency officials were not available to respond to questions about the approval.

Pfizer has global rights to nonprescription sales of the drug, which has been a blockbuster Rx product for AstraZeneca PLC. AstraZeneca filed the switch NDA for the 20 mg version Nexium in the first half of 2013 (Also see "Nexium OTC Switch Would Face Crowded Field, Potential Questions" - Pink Sheet, 20 Aug, 2012.).

Pfizer in August 2012 announced an up-front payment of $250 million to AstraZeneca for Nexium OTC rights. Additionally, AstraZeneca, which also has filed a marketing authorization application for an OTC Nexium tablet with the European Medicines Agency, could receive milestone and royalty payments based on product launches and sales.

Jockeying For PPI Market Edge

In addition to Prilosec OTC (omeprazole 20 mg), which also originated as an AstraZeneca Rx product, the U.S. nonprescription PPI market includes Prevacid 24HR (lansoprazole 15mg) marketed by Novartis AG, Zegerid OTC (omeprazole 20mg/sodium bicarbonate 1100 mg) marketed by a Merck & Co. Inc. business and private-label versions of Prilosec OTC and Prevacid 24HR.

All OTC PPIs now marketed as well as Nexium 24Hour are available only in tablet or capsule form, except for Zegerid, available in powder as well as tablet.

AstraZeneca, which launched prescription Nexium in Europe in 2000 and the U.S. in 2001, will continue to manufacture and market the Rx product. It is approved for Rx distribution in the U.S. in 2.5, 5, 10 and 40 mg doses; the switch application in Europe also is for a 20 mg dose.

FDA’s approval of Nexium OTC comes after P&G asked the agency to deny labeling for any OTC PPI candidate that could cause consumers to believe the product works better than P&G’s Prilosec OTC.

In a November 2014 citizen petition, P&G stated although it did not have knowledge of the label language AstraZeneca requested in the Nexium OTC switch application, the firm asks FDA to limit the product’s label to the same language used in other OTC PPIs (Also see "P&G Targets Proposed Nexium Switch In Petition For PPI Labeling Limits" - Pink Sheet, 19 Nov, 2013.). Label information was not available March 29 for Nexium OTC.

P&G’s petition argued it would be inappropriate to approve any label text likely to convey to consumers that an OTC version of Nexium works faster, differently or is otherwise more efficient than Prilosec OTC. The petition added that without data “demonstrating superior efficacy, P&G requested that the Nexium OTC label bear the same text” currently used for Prilosec OTC.

Another gambit in garnering an OTC switch market advantage came in 2013 when Sanofi tried to force a period of exclusivity for its OTC switch Nasacort Allergy 24HR, approved in October, by suing FDA to block disclosure of labeling prior to the product’s launch. Sanofi argued FDA should not be allowed to post the packaging and labeling for OTC Nasacort (triamcinolone nasal spray) on the agency’s website until the drug launches OTC because its proprietary information was submitted to FDA confidentially as part of its application to switch the product (Also see "Martek/Mead Agreement" - Pink Sheet, 22 May, 2006.).

Although FDA contested the firm’s allegations, Sanofi’s litigation could be a model for delaying private-label competition because it kept labeling of Nasacort Allergy 24HR under wraps for roughly five months before its launch in February 2014. The firm and the agency agreed to dismiss the lawsuit when the product launched.

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.