RE:RE:new drugs, very strategicBased on info provided, all we know is they have changed their formulas from generics, which is an exact copy of Bracco products, and created new formulas. Until they run patient tests, they probably will not know the difference in imaging?
The important aspect is drug IP, that is what gives value to pharma companies. This is what ChatGPT says about the 5052b license:
The FDA 505(b)(2) pathway is a streamlined approval process for new drug applications (NDAs) in the United States. It allows a sponsor to rely, at least in part, on existing safety and efficacy data that was not generated by the applicant. This pathway is commonly used when developing modified versions of approved drugs or for drugs that have new formulations, new routes of administration, or new indications.
Here are the key advantages of the 505(b)(2) pathway:
1. Reduced Development Time and Costs
- Less Clinical Testing: Sponsors can rely on existing data (such as published literature or data from previous studies), reducing the need for conducting extensive new trials. This cuts down both the time and costs associated with drug development.
2. Flexibility in Data Use
- Bridging Existing Studies: The applicant can reference studies already performed by others, such as studies supporting the approval of a previously approved drug (505(b)(1)). This allows flexibility when the drug is similar to an already approved product.
3. Patent Protection and Market Exclusivity
- Market Exclusivity: Drugs approved through this pathway may be eligible for 3 to 7 years of market exclusivity, depending on the modifications made to the drug (e.g., new use, formulation, or route of administration). This period allows the sponsor to market the drug without generic competition.
4. Faster Time to Market
- Fewer or Smaller Clinical Trials: Because the sponsor can leverage existing data, the clinical trial requirements are generally fewer than with a traditional 505(b)(1) NDA. This can lead to faster approval and market entry, allowing a company to capitalize on market opportunities more quickly.
5. Potential for Lower Risk
- Lower Risk of Development Failure: Since the sponsor is relying on previously established data, especially regarding safety, the risk of unexpected issues during drug development is reduced compared to a traditional new chemical entity (NCE) submission.
6. Opportunity for Drug Differentiation
- Modifications of Existing Drugs: The pathway allows sponsors to develop differentiated products (e.g., extended-release versions, combination products, new indications) without having to start from scratch, enabling companies to enter markets with a new or improved version of an existing drug.
Use Cases for 505(b)(2) Pathway:
- Developing a new formulation or delivery method of a previously approved drug.
- Creating a combination drug from two previously approved drugs.
- Seeking approval for a new indication of an existing drug.
By reducing the need for extensive testing while allowing for market exclusivity, the 505(b)(2) pathway is an efficient and cost-effective route for drug developers.