Bausch Health and its subsidiary, Salix Pharmaceuticals, started a patent infringement case against Norwich Pharmaceuticals in June 2024. This Norwich Pharmaceuticals patent lawsuit is focused on the generic version of XIFAXAN®.
This medicine is utilized for treating irritable bowel syndrome with diarrhea (IBS-D) and lowering the risk of hepatic encephalopathy recurrence.
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Case Overview: Bausch Health vs. Norwich Pharmaceuticals
After Norwich submitted a Paragraph IV Certification notice to the U.S. Food and Drug Authority (FDA) on May 10, 2024, Bausch Health and Norwich Pharmaceuticals started this conflict.
Norwich said in its notice that it plans to manufacture a generic form of XIFAXAN® 550 mg tablets from Bausch Health. For Bausch Health, XIFAXAN® has been a key product for the company, particularly in treating IBS-D and hepatic encephalopathy.
Declaring that Norwich’s activities breached their patent rights, Bausch Health replied by suing for patent infringement in the U.S. District Court for the District of New Jersey.
Following a court decision rejecting the FDA’s approval of Norwich’s initial Abbreviated New Drug Application (ANDA) for XIFAXAN® 550 mg until 2029, Bausch Health won a similar action against Norwich in 2022.
Bausch Health is relentless in its legal fight against Norwich. A verdict now prohibits generic copies of XIFAXAN® from being sold until 2029, and additional patents further shield the medication.
Therefore, this latest Norwich Pharmaceuticals patent lawsuit carries on Bausch Health’s fight to preserve XIFAXAN®’s market exclusivity.
The case is a prime illustration of how pharmaceutical firms negotiate patent law to keep exclusivity over their goods in the face of generic medication manufacturers.
Key Allegations in the Lawsuit
Overall, the case of Norwich Pharmaceuticals patent lawsuit mostly revolves around the following main accusations:
1. Patent Infringement
As noted earlier, the dispute between Bausch Health and Norwich Pharmaceuticals revolves mostly around the claim of patent infringement.
According to Bausch Health, Norwich is trying to promote a generic form of XIFAXAN® (rifaximin) 550 mg tablets, a medicine meant to treat irritable bowel syndrome with diarrhea (IBS-D) and lower the risk of overt hepatic encephalopathy.
Norwich’s legal action was set off when Norwich filed an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) in 2024 for clearance for this generic variant.
In this case, the Paragraph IV Certification submitted by Norwich questioned the validity of Bausch’s XIFAXAN® patents.
2. Violation of Patent Exclusivity
Violation of patent exclusivity is another main complaint in this Norwich Pharmaceuticals patent lawsuit. Patent exclusivity gives Bausch Health the exclusive right to manufacture and distribute XIFAXAN® for a certain duration.
Before the exclusivity term expires, Norwich’s effort to produce a generic version challenges Bausch’s market monopoly over the medicine.
Following the litigation for 2022, Bausch Health has obtained further patents to protect XIFAXAN®’s unique formulation and use in IBS-D treatment.
These patents guarantee Bausch maintains a competitive advantage in the gastrointestinal medicine industry and extends market exclusivity.
3. Market Disruption
The Norwich Pharmaceuticals patent lawsuit also addresses the possible disturbance of the market brought about by Norwich’s plan to release a generic version of XIFAXAN®.
Usually supplied at less cost, generic pharmaceuticals are more readily available but also reduce the market share of the original branded medicine.
The launch of a generic XIFAXAN® might challenge Bausch Health’s stronghold in the IBS-D treatment market, influencing profitability and sales. Thus, breaching this exclusivity poses a major financial and legal difficulty.
For your information, XIFAXAN® is Bausch Health’s main product; hence, any disturbance in its market might cause significant income loss. Reaching $1.05 billion, Bausch claimed a 4% sales growth alone in 2024 with its products.
Potential Consequences of the Lawsuit
The result of this Norwich Pharmaceuticals patent lawsuit may have wide effects on the pharmaceutical sector and Bausch Health and Norwich Pharmaceuticals. Some possible outcomes include:
1. Extended Market Exclusivity
Should Bausch Health be able to defend its patents, XIFAXAN® would remain market-exclusive for the firm until 2029. This would enable Bausch Health to keep control over a very lucrative product free from generic competition.
This would stop Norwich and other generic producers from launching their versions of the medication onto the market during this time.
2. Financial Ramifications
As noted, XIFAXAN® is a major source of income for Bausch Health, so keeping its market exclusivity has significant financial advantages.
Conversely, Norwich stands to gain financially should the FDA finally approve its ANDA for a generic form of XIFAXAN®.
Simply said, a positive outcome for Bausch Health might guarantee ongoing income from XIFAXAN®. At the same time, a finding in favor of Norwich would cause major losses for the company when generic versions of the medication become accessible.
Therefore, the Norwich Pharmaceuticals patent lawsuit affects the financial health of both firms, so it is not just a matter of patent protection alone.
3. Impact on Future Patent Litigation
Lastly, the situation involving Bausch Health and Norwich will certainly establish a standard for future pharmaceutical patent infringement litigation.
If Norwich successfully contests Bausch Health’s patents, other businesses might be encouraged to follow suit, increasing the likelihood of more regular challenges to sector patent exclusivity.
Given their continuous dispute, Bausch Health and Norwich Pharmaceuticals clearly show how important intellectual property, especially patents, is to businesses in the pharmaceutical sector.
Am Badar & Am Badar is ready to help you whether your company is experiencing the same patent problems or if you’re trying to protect your innovation. Visit our comprehensive services page or our Patent Dispute Service for more information.
Our team of experienced IP lawyers can help you navigate complex patent disputes and provide tailored solutions to protect your rights, such as this Norwich Pharmaceuticals patent lawsuit.
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