DrugPatentWatch serves companies across the drug development-delivery sector. A common request among drug manufacturers, payers, and suppliers alike is anticipation of which branded drugs will face generic competition, and when those generic drugs will launch.
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What factors influence generic launch?
There are many factors that influence the attractiveness for generic entry, and once you know where to look there are several rapid ways to anticipate generic launches.
Revenues
One of the primary drivers for generic entry is the anticipated revenues. So, an initial screen is to look for drugs with a threshold revenue level, like $100mm in annual sales. In our experience, however, generics may enter much smaller markets for strategic reasons such as alignment with other drugs in the portfolio, or the search for low-competition opportunities.
Ignore patents and regulatory exclusivity
Patents and regulatory exclusivity constrain generic entry, but these can be difficult to interpret, and patent challenges may create opportunities for earlier-than-anticipated generic entry (see the case study on Viagra). So, while it may seem counter-intuitive to ignore patents and regulatory exclusivity, we provide tools to identify and track market signals which can anticipate early generic entry.
Start with litigation
For popular drugs, successful patent litigation may allow generic entry far earlier than anticipated by the patent expiration dates. The earliest opportunity for novel drugs in the US is generally between 4 and 4 1/2 years from launch (This is called the NCE-1 date; for more see our list of upcoming NCE-1 dates).
An added benefit of tracking litigation is that it is a strong indicator of the interest among generic firms in entering a market — the observation that generic firms have invested the time and money necessary to submit generic approval documents, and that they are willing to face patent infringement litigation, indicates strong interest in generic launch. So, even if the patent challenges fail, the presence of litigation is a strong indication that generics will launch once patents expire.
Who has challenged a patent?
One limitation of using FDA data to track litigation is that while the FDA does disclose that drugs are subject to patent challenges (called Paragraph IV certifications), they do not name the companies which have launched these challenges.
So, how can you identify the generic companies that have launched patent challenges? We have detailed listings of patent litigation where you can track all the companies which have been sued for patent infringement — this will help you identify the generic patent challengers.
Ready to launch – tentative approvals
Assuming drug patent litigation is successful, which companies will launch generic drugs? The first place to look is the companies that have tentative approvals for the drug.
Tentative approvals are granted to companies that have met the requirements for drug approval, but are blocked from entry due to issues such as patents or regulatory protections. These companies will likely be the first-to-market, so tentative approvals can be useful to identify sources to acquire generic drugs and potential clients for API sales, marketing, distribution or other supportive services.
What about 505(b)(2) hybrid drugs?
Don’t forget 505(b)(2) drugs! These ‘hybrid’ drugs share regulatory characteristics between branded and generic drugs. This is the pathway used by drug reformulations, new combinations, over-the-counter switches, or other modifications that are not eligible for the generic approval pathway but are also not brand-new drugs.
For branded companies wanting to know about companies who may be ‘working around’ their patents, 505(b)(2)s are a great place to look. Likewise API suppliers and research tool makers can approach companies seeking 505(b)(2) approvals to pitch them well before they have finalized their supply chain.
Finally, payers can track 505(b)(2)s to identify drugs which may have improved characteristics over branded and generic drugs alike.
For more, see our list of companies running clinical trials for 505(b)(2) drugs.
