Last updated: June 1, 2026
ASPRUZYO SPRINKLE (rifaazydine? / “rifaximin”? ) is a prescription pediatric formulation; supplier coverage for the drug, including API makers, finished-dose manufacturers, and contract packagers, requires Orange Book and FDA labeling supply-chain disclosures tied to the specific strength, NDA holder, and manufacturing sites listed for the marketed product.
No marketable supplier list can be produced from the information provided.
What companies supply ASPRUZYО SPRINKLE to pharmacies and wholesalers?
A complete supplier map requires the NDA holder’s labeled manufacturing information (drug substance and drug product sites) and any listed third-party manufacturers in the FDA labeling and Orange Book record for ASPRUZY SPRINKLE. That data is not present in the prompt.
Does ASPRUZYO SPRINKLE use a contract manufacturer or is it made in-house?
Answer depends on the manufacturing site(s) shown in FDA labeling for the marketed dosage form and strength. Without the specific label/NDA record for the exact product, the contract vs. in-house determination cannot be stated.
Which wholesalers distribute ASPRUZY SPRINKLE?
Wholesaler distribution varies by channel and may include multiple distributors in the US. The prompt does not specify geography, channel, strength, or whether the question targets the US commercial supply chain.
What patents protect ASPRUZYO SPRINKLE formulations and manufacturing methods?
Patent coverage depends on the exact NDA and the Orange Book listings for ASPRUZY SPRINKLE, including formulation, polymorph, particle size, process, and use patents. No Orange Book entry set is provided in the prompt.
How many patents cover ASPRUZYO SPRINKLE in the Orange Book?
Counts require the specific Orange Book record for ASPRUZYO SPRINKLE (NDA number), including patent numbers and expiration dates.
Which formulation patents cover the “sprinkle” delivery system?
Sprinkle-specific protections are often tied to particle size, coating, taste-masking excipients, and mixing/dosing instructions. Without the FDA label and listed patents, the protected formulation claims cannot be enumerated.
When does ASPRUZYO SPRINKLE lose exclusivity and open supplier capacity?
Exclusivity timing depends on FDA regulatory exclusivities tied to the NDA and any pediatric exclusivity extensions. The prompt provides no NDA identifiers, approval date, or exclusivity periods.
What is the exclusivity timeline for ASPRUZYO SPRINKLE (NCE, Hatch-Waxman, pediatric)?
A timeline requires NDA approval date and exclusivity awards (e.g., 5-year NCE, 3-year New Clinical Investigation, pediatric 6-month extension).
What generic or biosimilar entry risks exist for ASPRUZYO SPRINKLE?
Generic entry risk is assessed via Paragraph IV filings, Orange Book 30-month stays, and litigation settlements. None of that information is supplied.
Are there ANDA or 505(b)(2) applicants targeting ASPRUZYO SPRINKLE?
Answer requires ANDA/505(b)(2) database evidence against the Orange Book patents for the specific product.
Which companies are challenging ASPRUZYO SPRINKLE with Paragraph IV?
Paragraph IV challenger names require sourcing from FDA’s ANDA status and litigation dockets.
How does ASPRUZYO SPRINKLE compare with alternative pediatric formulations from other suppliers?
Comparison requires identifying the active ingredient, strength, dosage form (e.g., granules for oral suspension vs sprinkle vs chewables), and the approved alternatives. The prompt does not include the active ingredient or the market comparator set.
Key Takeaways
- A supplier list for ASPRUZYO SPRINKLE cannot be produced from the information provided.
- Market supply-chain identification for drug product, API, and intermediates depends on the NDA-specific FDA Orange Book and labeling manufacturing-site disclosures that are not included here.
FAQs
- Who is the NDA holder for ASPRUZYO SPRINKLE?
- Which manufacturers are listed on the ASPRUZYO SPRINKLE FDA label for drug product and drug substance sites?
- Are there contract manufacturing organizations (CMOs) associated with ASPRUZYO SPRINKLE’s “sprinkle” formulation?
- Does ASPRUZYO SPRINKLE rely on outsourced API sourcing, and who are the drug substance manufacturers?
- What is the Orange Book patent estate for ASPRUZYO SPRINKLE and how does it affect supply availability?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA data systems, not provided in prompt.)
- FDA Prescribing Information for ASPRUZYO SPRINKLE. (Not provided in prompt.)
