Leiner Expands OTC Portfolio With Phenylephrine HCl, Ibuprofen Offerings

Leiner plans to launch phenylephrine HCl 10 mg - a "next option" nasal decongestant - in early 2005 to reach an untapped market, the firm announced at the PLMA trade show in Chicago Nov. 14-16.

The phenylephrine product will be indicated for the treatment of nasal and sinus congestion and sinus pressure. Leiner will manufacture the decongestant in 18- and 36-count blister packs.

More than 60% of the OTC nasal decongestant market is comprised of products containing pseudoephedrine, Leiner says, but those products "have come to bear state and DEA restrictions due to their status as methamphetamine precursor[s]."

Pseudoephedrine products' use in meth production has been at the center of both state and federal legislation this year, including a congressional bill proposing to move tablets containing the ingredient behind the counter (¹ (Also see "Pseudoephedrine Behind-The-Counter Sale Proposed In Congress; CHPA Balks" - Pink Sheet, 22 Nov, 2004.), p. 12).

Phenylephrine is seen as a potential alternative to pseudoephedrine among both branded and private-label cough/cold manufacturers. Pfizer is rumored to be launching a phenylephrine product under the Sudafed brand in early 2005; the brand will compete with several private-label alternatives.

Leiner also is engaged in an ongoing re-launch of its ibuprofen 200 mg liquid softgels, bioequivalent to Wyeth's Advil Liqui-gels. Leiner voluntarily withdrew the softgels from retail shelves last December.

The Carson, Calif.-based firm says the Advil product recorded $76 mil. in annual sales, and projects the store brand's annual sales will reach $15 mil. at food, drug and mass outlets, excluding Wal-Mart.

On the supplement front, soy-derived PS (phosphatidylserine 100 mg) will come in 60-count bottles that carry an SRP of $23.99 for a 60-tablet bottle.

PS will carry the FDA-approved health claims for phosphatidylserine, including "May reduce the risk of dementia in the elderly."