Branded generics transform the old into the new

In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 

Rubbing pill bottles isn’t likely to bring forth any genies ready to grant three wishes, but the idea of inputting something old and outputting something shiny and new is sort of the gist behind 
branded generics.

According to IMS Health VP industry relations Doug Long, “branded generics” has multiple meanings. One refers simply to generic drugs given brand names, such as a number of generic contraceptives on the market that carry brand names because calling them by their full generic names would be too cumbersome. Another kind of branded generic consists of a drug that has lost patent protection for which a drug maker develops a novel method of delivery to create a new drug. Last month, EffRx and Mission Pharmacal launched Binosto, which takes the generic osteoporosis drug alendronate sodium and reformulates it as an effervescent tablet that dissolves in water, a similar drug-delivery method 
to Alka-Seltzer.

The top-selling and probably best-known branded generic is Perdue Pharma’s OxyContin, an extended-release formulation of the generic opioid painkiller oxycodone. OxyContin itself is scheduled to start losing patent protection in April 2013.

Another use for off-patent molecules, Long said, is to pair them with another molecule to create a branded drug. Vintage Pharmaceuticals, for example, markets Percocet, which combines oxycodone and acetaminophen. Endo Pharmaceuticals, meanwhile, markets Percodan, a cross between oxycodone 
and aspirin.

In the meantime, branded drug makers will continue finding ways to get the most out of the drugs they’ve developed.

A long-standing practice has been what Long calls “incremental improvements,” like launching an extended-release formulation of an existing drug, but these efforts have been getting less successful, he said. Perhaps a similar approach is to come up with entirely new modes of delivery. United Therapeutics Corp.’s patents on the pulmonary arterial hypertension drug treprostinil — which it markets as the injected drug Remodulin and the inhaled drug Tyvaso — are expected to expire between 2014 and 2029, according to Food and Drug Administration records. Meanwhile, Sandoz, the generics arm of Swiss drug maker Novartis, is looking to market a generic version of Remodulin, though United Therapeutics filed a lawsuit against Sandoz in March to prevent it from launching. But in October 2012, United Therapeutics received a complete response letter from the FDA for a tablet formulation of treprostinil; a complete response letter means that the FDA has finished examining a regulatory application for a drug, but questions remain that 
preclude approval.

Click here for the full 2012 Generics Report.

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