Branded generics offer new ways to reformulate drugs

In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


Today, many drug makers are taking old drugs and turning them into new drugs, but there’s no sorcery here. Branded generics offer drug makers an opportunity to find new ways to formulate drugs that have lost patent protection and gone generic, and some are making quite a bundle in the process.


“It’s part of a movement to get out of the commodity part of the generics business,” IMS Health VP industry relations Doug Long told Drug Store News. “Branded generics is part of that, but also injectables, nasal and [dermatology drugs].”


“Commodity generics” are drugs that might have had a good run for the first company, winning approval for the generic version and getting 180 days in which to compete directly against the branded manufacturer, but have since seen a huge reduction in price due to the market entry of companies that sometimes number in the dozens.


By contrast, IMS defines branded generics as either novel dosage forms of drugs that have lost patent protection and were not developed by the company marketing the branded generic, or simply as a generic drug that’s given a trade name. Well-known drugs that fall into the first category are Purdue Pharma’s OxyContin, an extended-
release formulation of the generic opioid oxycodone, or Johnson & Johnson’s attention-deficit hyperactivity disorder drug Concerta (methylphenidate), which uses the same active ingredient as Novartis’ Ritalin, originally approved by the Food and Drug Administration in 1955. According to IMS, OxyContin ranks as one of the top-selling drugs in the country, with 2010 sales of $3.1 billion. 


Many drugs in the second category are generic contraceptives, such as Teva Pharmaceutical Industries’ Camrese (levonorgestrel and ethinyl estradiol tablets), which is a generic version of Duramed Pharmaceuticals’ Seasonique, of which Watson Pharmaceuticals also makes a generic version under the brand name Amethia. The reasons why Teva, Watson and others adopt brand names for these drugs: The generic names are simply too much of a mouthful.


“If you didn’t invent the product, you could come up with a superior delivery system like OxyContin,” Long said. “That could certainly be quite lucrative.”


FDA regulations treat branded generics as branded drugs. For example, when Purdue Pharma filed for regulatory approval of OxyContin, it filed a new drug application; FDA approval entitles a branded generic to five years’ market exclusivity, but with less patent protection than there is for a newly developed molecule. By contrast, a company making a generic immediate-release formulation of oxycodone would use an abbreviated new drug application.


Branded generics appear to be one example of a broader industry move in recent years toward what might be termed “value-added generics,” which could also include knockoffs of difficult-to-make drugs like Sanofi’s blood-thinning drug Lovenox (enoxaparin sodium) and Teva’s multiple sclerosis treatment Copaxone (glatiramer acetate) and, thanks to provisions in the Affordable Care Act, follow-on biologics.


“Now you have other people trying to get into the market where there are higher barriers to entry. It’s a little less competitive, and there’s a chance to get higher profit margins,” Long said.