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Drugs can have many patents and regulatory protections
Drugs can be covered by myriad patents and regulatory protections. Even Aspirin, which was first invented in 1853, has new patents. For example, patent 9,226,892 describes targeted release of pharmaceuticals and mentions aspirin in its claims. Patents like this generally don’t block generic entry — they cover secondary applications and improvements to drugs — but they can make the process of determining generic market entry dates complicated.
And patents are not the only ways that brands can keep generic drugs at bay. In the United States, for example, the FDA grants temporary market exclusivity for new drugs, for new uses of existing drugs, for drugs targeting rare diseases (Orphan Drugs), and more.
Navigating this web of drug patents and regulatory protections is necessary to determine generic entry opportunities, and there is a simple 1-step solution to streamline the process.
Why is it important to know when generics can launch
Many DrugPatentWatch clients have an interest in knowing when generic drugs can launch. Healthcare payers, for example, need this information to forecast their future formulary budgets and to prepare copayment tiers to accommodate generic entry. Wholesalers and distributors need to anticipate generic availability to prevent overstock of branded drugs. And generic pharmaceutical companies have a clear need to know generic entry dates so that they can manage their portfolios and prepare abbreviated new drug application submissions well in advance of the market entry dates.
Finding the generic entry opportunity date
As mentioned above, patents can claim different inventive steps. They may claim a drug compound, a drug’s formulation, its manufacturing methods, its use for treating specific diseases, and more. With the many patents protecting a drug it can be challenging to discern which block generic entry. The regulatory protections often expire before the patents do, but it is important to also be aware that there cases where the regulatory protections supersede the patents; so it is important to consider them as well.
To help you process the numerous factors influencing generic entry we present a simple, single, generic entry opportunity date. We calculate this by taking the latter of the drug compound-claiming patents and the regulatory protections available to a drug. While many factors may influence generic market entry (for example, litigation can invalidate patents prior to their expiration dates, and generic companies may elect not enter the market on the first available day) the Generic Entry Opportunity Date provides a rapid single-step process to estimate when generic drugs may launch.DrugPatentWatch. Originally published at Generic Drug Launch Dates – A 1-step Solution to Navigate the Web of Drug Patents and Regulatory Protections