Suppliers and packagers for DOPTELET SPRINKLE

DOPTELET SPRINKLE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Akarx Inc	DOPTELET SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696	NDA	AkaRx, Inc.	71369-010-30	1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE	2025-07-25

Doptelet Sprinkles Suppliers: Who Makes the Drug, Who Supplies Key Components, and What Procurement Paths Exist

Last updated: May 15, 2026

Executive summary

• DOPTELET Sprinkles (avatrombopag) is manufactured and supplied through a branded pharmaceutical supply chain centered on its FDA-approved drug product maker and upstream excipient and packaging vendors.
• Public, procurement-grade supplier identification for “Sprinkles” specifically depends on the exact approved presentation listed in FDA filings and on the Orange Book and labeling supply/manufacturing statements.
• With the information provided, a complete, accurate supplier list for DOPTELET SPRINKLETS cannot be produced.

What suppliers make DOPTELET SPRINKLE (avatrombopag) drug product?

DOPTELET is an avatrombopag brand. Supplier mapping requires identifying the company listed as the drug product manufacturer on the approved label and in FDA application manufacturing sections for the specific dosage form (“Sprinkles”). That supplier can be different from the manufacturer for tablets or other presentations.

Which company is the FDA-registered drug product manufacturer for DOPTELET Sprinkles?

The definitive answer is the name(s) printed in the approved U.S. label under “Manufactured for” and “Manufactured by,” plus the facility listed in FDA product information for the specific NDC tied to the Sprinkles presentation.

Are there multiple contract manufacturers for DOPTELET Sprinkles?

Brand manufacturers often use more than one CMOs site for scale-up or regulatory redundancy. Determining that requires the facility-level manufacturing information tied to the Sprinkles-specific NDC(s).

What excipient and packaging suppliers support DOPTELET SPRINKLES manufacturing?

For pharmaceutical procurement, “suppliers” usually means two layers:

1. Finished dosage form manufacturing (CMO/CDMO or internal site)
2. Upstream component supply (excipients, coating materials, printing inks, packaging components)

Which excipients are used in DOPTELET Sprinkles formulations?

Excipients are listed in the approved label and compendial product description for the Sprinkles dosage form. The excipient supplier tier cannot be reliably mapped from the label alone without FDA drug master file (DMF) cross-references or commercial procurement disclosures.

What packaging components are used for Sprinkles?

Packaging includes the container closure system for the Sprinkles unit (for example, bottles, child-resistant closures, and desiccant liners if used). Facility- and NDC-specific packaging suppliers are generally traceable only via labeling supply statements or CMO procurement disclosures tied to the finished product.

What patents and Orange Book listings affect supply continuity for DOPTELET SPRINKLES?

Supplier and manufacturing continuity interact with:

• regulatory exclusivity (preventing generic substitution)
• formulation and method-of-use IP (which can constrain supply diversification)
• FDA listing requirements and ANDA/505(b)(2) pathways

What is the Orange Book status of avatrombopag for DOPTELET Sprinkles?

Orange Book listings are presentation-specific and NDC-specific. A supplier assessment needs the exact Orange Book entry that corresponds to the Sprinkles dosage form.

When do exclusivity or relevant patents for DOPTELET Sprinkles expire?

A patent and exclusivity timeline is required to assess generics/biosimilars entry risk and downstream supply competition, which can alter supplier leverage and procurement options.

How does procurement sourcing differ between DOPTELET tablets and DOPTELET Sprinkles?

Manufacturing changes at the dosage form level can shift:

• the granulation and coating supply chain
• excipient vendors (different binder/disintegrant systems)
• packaging SKUs and labeling systems

Do tablet and Sprinkles share the same active pharmaceutical ingredient (API) supplier?

API suppliers can be shared or diversified, but a definitive determination requires:

• the API manufacturer listed in FDA application summaries, DMFs, or quality section references for avatrombopag bulk
• whether the API is sourced to one or more finished product sites

What generic or 505(b)(2) entry risks affect DOPTELET SPRINKLES sourcing?

If there is no permitted generic substitution, supply chain competition stays tighter and brand manufacturer leverage remains higher. If Paragraph IV or other challenges exist, it can drive:

• alternative sourcing bids
• manufacturing capacity reallocation
• component dual sourcing before potential launch

Are there ANDA or 505(b)(2) applications for DOPTELET Sprinkles?

Answering this requires checking FDA’s Orange Book for the Sprinkles presentation and any associated applicant and challenge details.

What litigation affects manufacturing or supplier continuity?

Patent litigation outcomes can drive:

• licensing and “authorized generic” manufacturing
• changes in IP carve-outs that alter who can manufacture the Sprinkles presentation

Key suppliers map for DOPTELET SPRINKLES: what a complete procurement package would include

A procurement-grade supplier list should enumerate, at minimum:

• Drug product manufacturer(s) and facility address(es) tied to the Sprinkles NDC(s)
• API manufacturer(s) for avatrombopag bulk substance
• Key excipient DMF holders (if any) and their referenced manufacturers
• Primary packaging supplier(s) for the container closure system
• Secondary packaging and labeling print suppliers (if applicable)

With the current prompt, those items cannot be filled with accurate names and facility identifiers.

Key Takeaways

• DOPTELET Sprinkles supplier identification requires Sprinkles-specific NDC-linked FDA label/manufacturing and Orange Book entry mapping.
• With only the request “Suppliers for DOPTELET SPRINKLE,” a complete and accurate supplier roster cannot be produced.

FAQs

1. What company manufactures DOPTELET Sprinkles in the U.S.?
2. Who supplies the avatrombopag API used for DOPTELET Sprinkles?
3. Which excipients are in DOPTELET Sprinkles and are any sourced via DMFs?
4. How do Orange Book patent listings for the Sprinkles NDC affect generic launch timing?
5. What would trigger changes in packaging suppliers for DOPTELET Sprinkles (NDC/label or CMO shifts)?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
2. U.S. Food and Drug Administration. Drug Labels and Product Information for DOPTELET (avatrombopag). (Accessed via FDA label repository).