Wyeth Alavert Approval Sparks Loratadine Price Wars, Fight For OTC Share

Wyeth Consumer Healthcare is staking a claim to the OTC loratadine market with Alavert pricing of 56¢ to $1 per orally disintegrating tablet and high-value coupons.

Alavert's pricing scheme sharply undercuts current pricing of Schering-Plough's Claritin RediTabs , which sell for approximately $1.29 to $1.49 per tablet in drugstores.

Wyeth, which received approval for Alavert orally disintegrating tablets on Dec. 19, immediately began shipping 12-, 24- and 48-counts; shipment of six-count packages are slated to begin the week of Dec. 23. Suggested retail prices are $5.99 (six-count), $10.99 (12), $18.99 (24) and $26.99 (48).

With its aggressive pricing strategy, Wyeth is aiming to grab OTC market share beyond that of just RediTabs. At Wyeth's SRPs, orally disintegrating Alavert is on par with or well below Claritin 10 mg tablets, which are retailing for approximately 90¢ to $1.35 per tablet (¹ 'The Tan Sheet' Dec. 16, 2002, In Brief).

Wyeth is undercutting both Schering's pricing and consumer promotional discounts to date for Claritin, which began reaching store shelves two weeks ago. Wyeth is offering $4-off coupons on a new dedicated Web site, ² www.alavert.com. In comparison, Schering has been featuring $1-off coupons on its Web site and in a Dec. 15 free-standing insert.

Alavert ads are likely to focus on the allergy remedy's convenience compared to traditional tablets that are swallowed with water, as well as loratadine's nonsedating properties and all-day symptom relief.

The Web site points out "Alavert comes in convenient tablets that melt in our mouth so you can take it with or without water - great for at home or 'on the go.'" The phrase "melts in your mouth" also appears on the product's principal display panel.

Despite its pricing strategy, Wyeth has its work cut out for it as it seeks to ingrain the new Alavert name into the minds of allergy sufferers who are far more likely to recognize the Claritin brand on store shelves.

In addition, Wyeth is looking to build an allergy franchise under the Alavert banner; the company said it plans to launch a 10 mg tablet and a decongestant combination product in 2003.

In its letter approving Wyeth's 505(b)(2) application for OTC loratadine, FDA notes it received NDA 21-375 on Sept. 4, 2001. Wyeth made 39 additional submissions through Dec. 13.

McNeil Consumer & Specialty Pharmaceuticals also filed a 505(b)(2) application for OTC loratadine 10 mg tablets OTC. However, the company said it has no plans to launch OTC loratadine "at this time" and will continue to focus on its Tylenol line of upper respiratory products. McNeil says it has not withdrawn its application, which was deemed "approvable" in July.

Although Wyeth also has a pending ANDA, with accompanying "first-to-file" status for the RediTabs equivalent, the application has been revised to remove language for a chronic idiopathic urticaria indication, the company said. Applications approved under 505(b)(2) are not entitled to six months of generic exclusivity.

Alavert's indications are the same as those approved for Claritin - "temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose; sneezing; itchy, watery eyes; and itching of the nose and throat" (³ (Also see "Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports" - Pink Sheet, 2 Dec, 2002.), p. 3).

In its approval letter, FDA requests Wyeth submit "copies of the introductory promotional materials you propose to use for this product." The materials should be submitted "in draft or mock-up form, not final print," to both the Division of Pulmonary & Allergy Drug Products and the Division of OTC Drug Products. FDA did not make a similar request of Schering in its approval letters for OTC Claritin.

However, like Schering, Wyeth's post-marketing commitments include submission of "information in each quarterly periodic safety report for the first three years after approval on reports from various sources of the occurrence of hypospadia cases." FDA began reviewing a possible link between loratadine and the birth defect hypospadia in May.

On Dec. 20, the agency said the data on loratadine, desloratadine (Schering' Clarinex ) and hypospadia are not convincing enough to justify a labeling change at this time for either the Rx or OTC products. The agency said it will actively review loratadine marketers' safety reports for the next three years for evidence that would warrant any future labeling change related to the birth defect.