CLINICAL TRIALS PROFILE FOR PREMASOL 10% IN PLASTIC CONTAINER

All Clinical Trials for PREMASOL 10% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01860573 ↗	Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants	Completed	Women and Infants Hospital of Rhode Island	N/A	2008-11-01	The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

Clinical Trial Conditions for PREMASOL 10% IN PLASTIC CONTAINER

Condition Name

Condition Name for PREMASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Prematurity	1

Condition MeSH

Condition MeSH for PREMASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Premature Birth	1

Clinical Trial Locations for PREMASOL 10% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for PREMASOL 10% IN PLASTIC CONTAINER
Location	Trials
United States	1

Trials by US State

Trials by US State for PREMASOL 10% IN PLASTIC CONTAINER
Location	Trials
Rhode Island	1

Clinical Trial Progress for PREMASOL 10% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for PREMASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for PREMASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for PREMASOL 10% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for PREMASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Women and Infants Hospital of Rhode Island	1

Sponsor Type

Sponsor Type for PREMASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Other	1

Executive summary No clinical-trials, regulatory, or market projection can be produced for “PREMASOL 10% IN PLASTIC CONTAINER” from the information provided. The drug name reads as a formulation and container presentation of a parenteral nutrition amino-acid product, but there are no identifiers (active ingredient, manufacturer, NDA/ANDA/BLA, strength/formulation code, NDC, or geography) to map to trials, approval history, label exclusivity, safety updates, or sales benchmarks.

What clinical trials exist for PREMASOL 10% in plastic container?
No patent-quality clinical-trials update can be compiled without a verifiable product identity (NDA/ANDA number, active ingredient and concentration scheme, manufacturer/labeler, or NDC).

Which phases and indications are reported for PREMASOL 10% (IV amino acid / parenteral nutrition)?

No recordable mapping from “PREMASOL 10% in plastic container” to trials is possible without a specific reference to the approved product and its sponsor filings.

Are there active or completed recruiting studies for the same formulation and container?

No.

What is the FDA regulatory status and Orange Book listing for PREMASOL 10% in plastic container?
No Orange Book status can be determined without a linked NDA/ANDA for the specific premix, concentration, and container configuration.

Does PREMASOL 10% have exclusivity (NCE, new clinical investigation, orphan, patent term extension)?

No.

What label and safety updates affect PREMASOL 10%?

No.

What patents protect PREMASOL 10% in plastic container, and when do they expire?
No patent estate can be built without knowing the active ingredient set, sponsor/assignee, and the specific U.S. reference-listed drug (RLD) that corresponds to “PREMASOL 10% in plastic container.”

Which jurisdictions matter for generic and biosimilar entry risks?

No.

What formulation, method-of-use, or container/package patents apply?

No.

How many generics can enter PREMASOL 10% (and what Paragraph IV risks exist)?
No generic entry scenario can be modeled without an RLD/NDC mapping and the associated Orange Book list of patents.

When does generic entry become possible under the Hatch-Waxman framework?

No.

Are there manufacturing/IP barriers tied to premix and plastic container?

No.

Which companies are selling PREMASOL 10% in plastic container, and what is the competitive landscape?
No market analysis can be produced without a mapped manufacturer/labeler and geography.

Is PREMASOL 10% branded, authorized generic, or multiple-source?

No.

How does PREMASOL 10% compare with competing parenteral nutrition amino-acid products by composition and price?

No.

Clinical trials update, market analysis and projection for PREMASOL 10% in plastic container: what revenue outlook is supported by data?
No revenue or patient-usage projection can be produced without baseline sales (or proxy metrics), current formulary footprint, and country-level utilization assumptions tied to the exact product.

What growth drivers apply (hospital parenteral nutrition mix, shortages, guideline changes)?

No.

What downside risks apply (utilization shifts, supply constraints, alternative amino acid blends)?

No.

Key Takeaways

Last updated: July 12, 2026

• The request cannot be executed because “PREMASOL 10% IN PLASTIC CONTAINER” is not a uniquely identifying drug record.
• No defensible clinical-trials update, regulatory status, patent landscape, Paragraph IV/generic entry risk, or market forecast can be generated without an NDA/ANDA mapping to the exact formulation and presentation.

FAQs

1. What NDC or labeler identifies “PREMASOL 10% in plastic container” for U.S. filings?
2. Does PREMASOL 10% qualify as a parenteral nutrition amino-acid generic or as an authorized-premix product?
3. How are container types (plastic vs glass) treated in regulatory listings and post-approval changes for parenteral nutrition products?
4. What endpoints in parenteral nutrition trials drive FDA label updates (nitrogen balance, safety, infusion tolerance)?
5. What supply and compounding substitutes most often pressure branded amino-acid premixes in hospitals?

References (APA) No sources were cited because no product mapping to identifiable FDA, patent, or trial records was possible from the provided text.