When filing an NCE-1 application, being the first applicant to do so is not just a badge of honor; it also gives a strategic edge. The Para IV filing offers exclusive opportunities to dominate the market before competitors enter the scene.
Despite this lucrative benefit, common myths persist, clouding judgment, delaying action, and costing companies millions in lost revenue. We have busted the top 5 myths that could be holding your team back. This blog will provide you with the information you need to make smarter, faster, and more profitable para IV filing decisions.
Myth 1: Filing a Para IV is a legal risk not worth taking
Fact: While a Para IV filing can lead to litigation, the potential reward far outweighs the risk.
The first-to-file ANDA applicant gains 180 days of market exclusivity, giving them a temporary monopoly and the opportunity to capture significant market share. For many generic manufacturers, this brief period translates into millions in revenue, making it a calculated legal risk worth taking.
Myth 2: NCE-1 filing is just a regulatory formality
Fact: NCE-1 filing is a time-sensitive, strategic opportunity, not a mere official document required to be filled in.
The coveted 180-day market exclusivity is awarded exclusively to the first generic applicant who files early and claims the status of first-to-file. NCE-1 filing should be done on the first day of the fourth year after the originator drug’s approval. Missing this narrow filing window can delay your product launch by years.
Companies using an NCE-1 intelligent platform can track NCE-1 dates, automate readiness, and minimize the risk of late submissions.
Myth 3: Any generic company can easily file a Para IV
Fact: While any company can file, success demands preparation, precision, and expertise.
Filing a Para IV application requires:
- Robust patent analysis
- Expert legal counsel
- Comprehensive bioequivalence and clinical data
- Coordinated regulatory strategy
Without these segments in place, generic companies might risk rejection, litigation losses, or regulatory delays. Partnering with experienced clinical trial sourcing companies with the NCE-1 intelligent platform can make a significant difference.
Myth 4: Multiple Para IV filers share the 180-day exclusivity
Fact: Only the first-to-file gets hold of this golden opportunity.
According to FDA guidelines, the 180-day exclusivity is awarded only to the first applicant to file a valid Para IV certification. Companies that miss the window often have to wait until the brand patent expires or until the litigation process plays out—sometimes taking years.
Speed, data readiness, and IP foresight are key to avail this 180-day exclusivity.
Myth 5: NCE-1 filings can happen anytime during exclusivity
Fact: There’s a strict and narrow filing window.
To gain the exclusivity benefit, your ANDA must be filed on the first day of year four after the new chemical entity (NCE) receives FDA approval.
Simplifying the journey of pharmaceutical companies in tracking NCE-1 opportunities is one of our main objectives. To achieve our objective, we have launched the NCE Grid. NCE Grid is the first-ever free platform bringing real-time intelligence on NCE-1 dates, Para IV opportunities, and insight into innovator companies under one simple dashboard.
Conclusion
In an industry where every launch delay equals lost market share, precision filing is not a luxury—it’s a necessity. The most successful pharmaceutical companies view Para IV filings not as administrative hurdles, but as strategic weapons. Understanding Para IV filing is key to success in the generics space. But common myths often lead to confusion or delays. This blog aims to clarify these misconceptions and help teams make informed decisions.
If you are looking for a reliable comparator drug sourcing solution, contact us now.
FAQs
Why is the 180-day exclusivity so important for generic manufacturers?
The 180-day exclusivity allows the first generic filer to be the sole competitor to the brand drug for six months. This temporary monopoly can generate millions in revenue before other generics enter the market, making it a highly strategic and profitable opportunity.
Can multiple companies share the 180-day exclusivity period?
No. Only the first-to-file ANDA with a valid Para IV certification is eligible for the exclusivity.
How can companies ensure they don’t miss the NCE-1 filing window?
Tracking NCE approval dates by NCE Grid can help companies stay ahead. These tools offer real-time intelligence on NCE-1 timelines, Para IV opportunities, and innovator drug insights, helping companies avoid delays and capitalize on exclusivity opportunities.
