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Home Treatment Options Treatment Options Weighing In on the End of a Patent

Weighing In on the End of a Patent

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In the pharmaceutical industry, the end of a patent brings much anticipated competition. Patents enable manufacturers to have exclusivity on their inventions for a set time period; this exclusivity staves off competitors wishing to manufacture a medication with a similar formulation. In the case of valacyclovir, a drug with annual sales of $1.3 billion dollars currently manufactured under the trade name Valtrex® by GlaxoSmithKline (GSK), the competition has become heated even before the patent ends in December.

Initially approved by the Food and Drug Administration (FDA) in 1995, valacylovir may be used to treat oral and genital herpes, shingles and chicken pox. Treatment for HSV may be taken epidsodically or suppressively. As demonstrated in the landmark study by Corey et al, valacyclovir taken daily also reduced the risk of transmitting herpes by forty eight percent, in conjunction with safer sex practices (abstaining during an outbreak and using condoms during sex).

In July 2009, GSK’s CEO Andrew Witt, commented on GSK’s strategic priorites: “We are working through a phase of extensive generic competition and building new capabilities to compete effectively in what is a rapidly changing environment for the pharmaceutical industry.” The CEO’s recognition of “extensive generic competition” is key and comes as no surprise if one has watched the wars being waged over manufacturing generic valacyclovir.

So far the battlefield of generic competition is being fought in the courts of GSK’s U.S. headquarters—North Carolina. First, Ranbaxy Laboratories Ltd., a producer of generic medications located in India, previously pursued litigation against GSK to produce generic Valtrex®. The settlement resulted in Ranbaxy garnering 180 days sale exclusivity when GSK’s patent ends. Now, according to the Triangle Business Journal, the pharmaceutical company Apotex has waged battle in an effort to usurp Ranbaxy’s exclusivity on manufacturing valacyclovir. They believe Ranbaxy’s manufacturing faults cited by the FDA in two warning letters should revoke their exclusivity.

Why go through the cost associated with legal proceedings? Gaining marketing exclusivity would ensure a six-month head start over competitors wishing to market their generic alternative. At press time the conclusion of this battle has yet to occur and the interest regarding the termination of the patent continues to prompt discussion.

Additional concerns have arisen over a generic alternative to Valtrex®. One point of contention is whether generics truly offer competition. Are they the same or not? There are several facts to bear in mind when discussing generic versus brand name medications. According to the FDA and scientific community, lower cost does not translate into lower efficacy. Among the reasons generics cost less are the savings recouped by manufacturers, who save on significant research and development costs, as the original manufacturers of the brand name drug conducted extensive research prior to launch. Additionally, marketing costs are less as many consumers are already familiar with the advantages of the brand name drug.

In regards to efficacy the FDA says “Any generic drug modeled after a single, brand name drug . . . must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability-just as there is for one batch of brand name drug to the next.”

The FDA also notes that in the United States the majority of prescriptions filled—7 out of 10—are for generic prescriptions. If the public is filling so many generic prescriptions how does the patent’s end resonate with them?

To get this perspective, The Helper turned to the users of ASHA’s public STI Message board. We asked our message forum visitors their opinions about whether the option of generic valacyclovir would have any impact on their personal treatment decisions:

“Well I’m really glad it’s finally coming off patent the end of this year even though it’s not a product I use personally (I use acyclovir myself). It’s too expensive if you don’t have a really good prescription plan but you can’t beat the convenience of once-daily dosing for suppressive therapy. Once it goes generic many folks can get it much cheaper both with and without insurance, which will be a good thing for many.”


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