Warner Chilcott is relying on FDA's tablet scoring policy to thwart generic competition for the 150 mg dose of its antibiotic Doryx (doxycycline).

Last month the agency issued a draft guidance on tablet scoring in which it recognized "the need for consistent scoring between a generic product and its RLD [reference listed drug]." Warner Chilcott subsequently obtained approval for dual-scored Doryx and is asking FDA not to approve any ANDAs of the product until sponsors adopt a dual-scored configuration.

In a Sept. 23 citizen petition Warner Chilcott says the agency "has repeatedly emphasized the importance of ensuring scoring consistency between generic drugs and their reference products." The company cites FDA's Manual of Policies and Procedures and its recent draft guidance (Also see "FDA Tablet Scoring Guidance Advises Testing Patient Ability To Split Pills" - Pink Sheet, 5 September, 2011.).

The draft guidance states that consistent scoring enables patients to switch between products made by different manufacturers without encountering problems related to the dose and "ensures that neither the generic product nor the RLD has an advantage in the marketplace because one is scored and one is not."

Will FDA Guidance Apply To Pending ANDAs?

Asked about the petition, the Generic Pharmaceutical Association said it "denounces this blatant, last-gasp attempt to delay patients' access to a safe and effective generic medication."

The association said Warner Chilcott's petition does not raise safety or efficacy issues, noting that the single-scored brand drug has been marketed for years. It stated that generic manufacturers would be "forced to spend months reworking their product merely to meet the new design."

Frederick Ball, a partner at Duane Morris who represents generic firms, said the petition's success will depend on whether Warner Chilcott can demonstrate there is a real safety and efficacy issue. He also questioned whether FDA's guidance would apply to pending ANDAs.

"It's hard for FDA to say it would penalize everyone who's submitted ANDAs," Ball stated.

Mylan Launch Blocked

Warner Chilcott has been seeking to block generic competition through patent litigation, filing infringement suits against Impax Laboratories Inc. and Mylan Inc. FDA approved Mylan and Impax's generic versions of Doryx 100 mg and 75 mg in December 2010. In an Aug. 5 10Q filing with the Securities and Exchange Commission, Warner Chilcott said it believes Mylan and Impax launched their products at risk in January.

In June FDA tentatively approved Mylan's ANDA for the 150 mg dosage of Doryx. However, in September a district court issued an injunction to block Mylan's launch of the product. Mylan said it filed a motion with the U.S. Court of Appeals for the Federal Circuit to stay the injunction and the court has granted an expedited appeal. A suit against Impax involving its 150 mg dosage remains pending.

Seeking Single-Scored Inventory Back

Warner Chilcott launched it new dual-scored 150 mg tablet into the market on Sept. 21 and plans to discontinue the 75 mg and 100 mg dosage forms. In its petition the company said it has asked major customers to return inventory of the single-scored product as they receive shipments of the dual-scored tablet and has sent letters to physicians and pharmacists to inform them of the scoring change.

Warner Chilcott notes that FDA has previously addressed tablet scoring in citizen petitions. The company cites a petition involving generic tramadol. In a 2002 response in that case FDA determined that generic 50 mg tramadol tablets did not need to be scored to permit 25 mg dosing. Warner Chilcott says in its case Doryx labeling recommends doses of 100 mg and 50 mg, which can be achieved with a dual scored 150 mg tablet but not a single-scored tablet.

The company also notes that FDA required ANDA applicants for 70 mg and 100 mg doxycycline to change to a scored tablet and conduct additional dissolution testing.

Warner Chilcott also says FDA should require and ANDA for a 150 mg tablet referencing Doryx to include the same labeling as Doryx.

Doryx had revenue of $98 million for the six months ending June 30.

- Brenda Sandburg (b.sandburg@elsevier.com)

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