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Pharmaceutical formulary managers have a pressing need to manage their formulary budgets. Anticipating when drugs will face loss-of-exclusivity — when their key patents will expire — is an essential first-step in projecting future budgets.
Once drug patents and regulatory protections expire generics are free to enter the market. We provide tools to help anticipate generic entry, to identify first generic entrants, and — importantly — to predict when generic competition will be sufficient for drug prices to drop substantially.
The first step in tracking generic drug launches is to set up an email alert. Our email alerts let you set up tracking for virtually every dataset we present. You can get alerts for new patents, for patent expirations and withdrawals, and for new generic approvals of any drug in the DrugPatentWatch platform.
These email alerts allow you to flag drugs of interest and passively monitor them for important patent or regulatory changes. Below we describe ways to actively forecast generic launches, to proactively identify generic entrants, and to refine your timelines for significant generic drug price decreases.
Earliest anticipated generic entry dates
Navigating the myriad factors impacting generic entry can be cumbersome when you need to establish and monitor predictions for a large portfolio of drugs.
We cut through this clutter using a proven methodology which predicts the earliest generic entry opportunity. Our methodology examines the various patents covering a drug and determines which single patent is most likely to limit generic entry. We then go further and look at regulatory exclusivities, and finally we integrate the patent and regulatory exclusivity dates to provide you with a simple estimate of the earliest generic entry opportunity date.
First generic entrants
Once you know when generics are likely to launch, the next question is “who will be the first generic entrant?” We present a simple way to find the first generic entrants — tentative approvals.
The FDA grants tentative approvals for generic drugs which are approvable but for the existence of conflicting patents. This list can help you identify companies with which to establish supplier relationships so you can benefit from lower generic prices as soon as the branded drug faces loss-of-exclusivity.
In the case of drug patent litigation, observing which generic companies have tentative approvals is an effective way to identify patent challengers who, if they prevail, may launch a generic version earlier than the anticipated patent expiration date.
Brands may launch ‘authorized generic’ drugs to participate in the generic market and increase price competition.
The presence of authorized generics in a market gives you three options:
- The original, branded, drug
- Generic drugs from third parties
- A relabeled package of the branded drug — an ‘authorized generic’
We help you identify these special cases to help you understand the competitive landscape of non-brand drug options.
When will generic prices drop?
Ultimately, the purpose of tracking generic entry for pharmaceutical formulary management is to anticipate when drug prices will drop. When there are very few generic options prices tend to remain high. It is only when a substantial number of generic entrants launch their drugs that price competition occurs and substantial price decreases are seen.
We help you monitor a special, and very frequent, situation which keeps generic prices high: generic exclusivity.
When a generic drug company successfully challenges a patent, they may receive 180-day generic market exclusivity. This reward for facilitating early generic entry effectively excludes other generic manufacturers and often means that drug prices don’t see significant decreases until the generic market exclusivity expires. We present a table of all the drugs with 180-day market exclusivity, along with the exclusivity expiration dates, so you can predict when generic prices will drop. If you integrate our tentative approval date (see First generic entrants, above) you can proactively identify the second-round generic entrants.
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Copyright © DrugPatentWatch. Originally published at Pharmaceutical Formulary Management: Anticipating generic entry, identifying first generic entrants, and projecting drug price drops