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Customer Success: API and CDMO Business Development

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Copyright © DrugPatentWatch. Originally published at Customer Success: API and CDMO Business Development

Changes in drug markets can create growth opportunities for API manufacturers and CDMOs alike.

Whether change comes from generic entry, from new formulations of drugs, or from competition from novel drugs, DrugPatentWatch can help API manufacturers and CDMOs find and capitalize on new opportunities.

Which generics are about to launch?

identify late-stage generic entrants with tentative drug approvals
Identify late-stage generic entrants with tentative drug approvals

The simplest way to find generic drugs about to launch is to look at tentative approvals.

While the FDA does not disclose the name of companies which have submitted drug applications until they approve those applications, looking at tentative approvals can reveal the names of generic companies who are waiting for key patents or regulatory approvals to clear. Once these key regulatory protections and patents have expired these generics are cleared to launch.

Which generics may enter in the next few years?

Identify first generic launches with patent litigation

As mentioned above, the FDA doesn’t disclose the names of companies filing for generic entry. This means that more advanced investigations are needed to identify potential future generic entrants.

One way to find future generic entrants is to look at patent litigation. The first generic entrants will often challenge the validity of drug patents to secure the earliest possible launch date. These companies will have already filed ANDAs with the FDA, and they face patent infringement challenges from branded drug companies — these are strong indications of the generic’s intent to launch.

While the FDA doesn’t disclose the names of patent challengers, the court records present an opportunity to identify the companies being sued for infringement — the likely patent challengers.

So, looking at records of drug patent litigation can identify potential generic entrants years before they may launch.

Identify future 505(b)(2) entrants before they file for approval

A 505(b)(2) application is a hybrid between a generic and a novel drug application. These applications are for modifications to a drug — a new formulation, manufacturing method or other alteration.

505(b)(2) drug launch entryDrugPatentWatch tracks 505(b)(2) clinical trials, helping you identify potential future entrants well before they file drug applications. This gives you ample time to approach these companies for opportunities to sell reagents, research tools, or additional formulation/manufacturing improvements they can use.

Anticipate sharp drops in demand

Beyond finding new opportunities, it is also vital for API manufacturers and CDMOs to anticipate negative impacts on their business.

The generic launch and 505(b)(2) entry cases presented above are useful to anticipate when demand for a branded drug may drop. Further DrugPatentWatch has lists of New Chemical Exclusivity (NCE) dates and 180-day market exclusivity expiration dates.

NCE-1 dates - drugs facing patent challengesBecause generic drug applications will not be received by the FDA until one-year before NCE expiration, you can use DrugPatentWatch’s list of NCE expirations to track which drugs may face generic entry. If a drug has no other patents or regulatory protections, then generic can enter after the NCE date. If patents to exist, then patent challenges may filed 1 year before the NCE date and, if the patents are invalidated, generics may launch after the NCE date.

So, tracking NCE dates can indicate when to watch for patent infringement and potentially for reduced brand-side demand as generic drugs launch.

drug patent challenge exclusivityFirst generic entrants who have successfully challenged and defeat a drug patent are eligible for 180-days of generic market exclusivity. API and CDMO companies serving these first entrants can use use the 180-day generic exclusivity expiration dates to anticipate when generic competition increases, or they can use these dates to find opportunities to partner with second-launch generics

A quick estimate of blocking patent expirations

generic drug launch dateDrugs can have many patents. This can present a challenge for companies seeking a simple estimate for when generics may launch.

API manufacturers and CDMOs can use DrugPatentWatch’s simple generic entry opportunity estimates for the business development timelines and prioritize which opportunities to pursue at which times.

Drugs in development

drugs in developmentJust as new generic entrants present strong business development opportunities for API suppliers and CDMOs, identifying companies drugs in development and the progress of development can identify opportunities for new or expanded business relationships.

DrugPatentWatch tracks patents, clinical trials, indications, and companies sponsoring research on drugs in development. You can use this business intelligence to grow your business with existing clients or to track the progress of future clients.


Just as branded and generic drug companies use DrugPatentWatch to find and evaluate commercial opportunities, the businesses which partner with branded and generic companies can use the same information to identify new clients or to anticipate changes in their existing relationships.

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Copyright © DrugPatentWatch. Originally published at Customer Success: API and CDMO Business Development
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