Perrigo Seeks To Slow Rivals’ Private-Label Prevacid Launches
This article was originally published in The Tan Sheet
Perrigo Co. PLC asks FDA for regulatory changes that would prevent other private labelers from launching a generic of the proton pump inhibitor Prevacid 24HR.
The firm makes two arguments in a citizen petition submitted to FDA Nov. 18 aimed at protecting the firm’s ability to win share in the eventual market for store brand versions of Prevacid 24HR (lansoprazole 15 mg).
Perrigo requests FDA “refuse to receive, or otherwise rescind its receipt” of any abbreviated new drug application for generic Prevacid 24HR capsules if the ANDA sponsor’s data rely on bioequivalence studies conducted on prescription Prevacid.
“Uncertainty exists with allowing an ANDA sponsor to rely on bioequivalence comparisons against the prescription version of a drug product that has switched to OTC status under a new NDA.”
–Perrigo
The Allegan, Mich., firm also asks FDA to drop the requirement that an OTC reference listed drug be launched before FDA will accept the submission of Rx bioequivalence data.
Novartis AG, under license from Takeda Consumer Healthcare Co., has marketed Prevacid 24HR OTC in the U.S. since 2009 following FDA’s approval and has exclusivity on U.S. sales through May 18, 2012 (Also see "Prevacid Initial Launch Efforts To Focus On Switching Prescription Users" - Pink Sheet, 16 May, 2009.).
According to FDA’s Orange Book database of active ingredients in Rx and nonprescription drugs, only Novartis has approval to market an OTC lansoprazole.
In its petition, Perrigo says it “believes that at least one” manufacturer has submitted an ANDA for a generic Prevacid 24HR containing the results of a bioequivalence study comparing its proposed lansoprazole to Prevacid Delayed-Release, the Rx version.
While the petition does not name the firm that filed the ANDA and waiver request, Dr. Reddy's Laboratories Ltd. is Perrigo’s largest competitor in the private label OTC market and the India-based firm likely will launch a generic Prevacid 24HR.
FDA cannot disclose information about a pending application, according to a Center for Drug Evaluation and Research spokeswoman.
Perrigo also argues it expects the ANDA contains “a request that FDA grant a biowaiver to relieve the sponsor from the need to conduct an in vivo bioequivalence study comparing its proposed drug product to the OTC version,” according to the petition, signed by Richard Stec, the firm’s VP of global regulatory affairs.
Perrigo believes FDA received the petition and granted a biowaiver “notwithstanding the fact” that the Rx and OTC versions “are different listed drug products.”
The firm said this summer it is readying its generic lansoprazole but did not specify when it would launch the product (Also see "Perrigo To Launch Private Label Mucinex, Prevacid, With An Eye On Lipitor" - Pink Sheet, 22 Aug, 2011.).
Prevacid 24HR had $116.4 million in sales for the year ended Oct. 30, a drop of 3.65% from the year-ago period, according to SymphonyIRI Group data covering supermarkets, drugstores and mass merchandisers, excluding Walmart. Procter & Gamble Co.’s Prilosec OTC (omeprazole) generated sales of $265.5 million during the same 52-week period.
Perrigo Objects To Rx Data Use
Perrigo also argues that FDA’s Office of Generic Drugs recently established an internal policy that the firm considers illegal: permitting an ANDA sponsor to use the Rx version of a product to demonstrate bioequivalence and obtain a waiver from demonstrating bioequivalence to the OTC, provided the Rx and OTC versions are identical except in appearance and the OTC version has been launched.
Perrigo says the Food, Drug and Cosmetic Act and the agency’s regulations on ANDAs require sponsors to cite a specific reference listed drug. In the case of lansoprazole, the OTC and Rx versions have different references.
Additionally, FDA has rejected firms’ use of tests on versions of drugs marketed overseas to prove bioequivalence to drugs sold in the U.S., Perrigo points out. The ANDA sponsor in such a scenario “cannot certify without doubt that the United States and foreign marketed drug products are made at the same site, under the same process, with the same critical processing parameters and with the same product specifications,” the firm says in the petition.
“Similar uncertainty exists with allowing an ANDA sponsor to rely on bioequivalence comparisons against the prescription version of a drug product that has switched to OTC status under a new NDA.”
ANDA sponsors may be permitted to study bioequivalence with Rx strength products and seek a waiver for the OTC strength product, but “determinations are made on a case-by-case basis and do not involve a change in CDER policy regarding bioequivalence testing requirements,” the FDA spokeswoman said in an email.
The agency in January 2010 outright rejected Reckitt Benckiser Group PLC’s attempt to delay private label competition for Mucinex OTC cough products by rejecting the firm's request to redefine bioequivalence standards for guaifenesin generics (Also see "FDA Denial Of Mucinex Petition Stops Reckitt's Bid To Delay Generics" - Pink Sheet, 18 Jan, 2010.).
Launch Date Requirement Creates New Burden
Perrigo also seeks to protect its route to ANDA filings by eliminating FDA’s existing requirement that an OTC reference listed drug be launched before FDA will accept the submission of Rx bioequivalence data.
The requirement “has no basis in law or regulation” and “appears to be intended to shield the agency from criticism” from the OTC reference drug sponsor that there is no drug on the market with which to demonstrate bioequivalence, Perrigo says.
The firm says what constitutes a product launch is unclear. FDA does not have a mechanism requiring brand-name manufacturers to notify the agency, so “it is unclear how FDA would validate a launch date against an ANDA submission date.”
The requirement “creates an uneven playing field for ANDA sponsors” because OTC products are not always launched nationwide. Competing firms may not learn of a small regional launch until well after the fact, “thereby delaying a timely submission,” Perrgio adds.
The firm says FDA should undergo the formal notice and rulemaking process as outlined in the Administrative Procedure Act.