Suppliers and packagers for generic pharmaceutical drug: HISTRELIN ACETATE

HISTRELIN ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058	NDA	Endo USA, Inc.	67979-002-01	1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS	2007-05-31

Suppliers and packagers for generic pharmaceutical drug: HISTRELIN ACETATE

Last updated: May 23, 2026

Histrelin Acetate Suppliers: Who Manufactures the Implant and What Company Sources Control Supply?

Histrelin acetate is supplied primarily as histrelin acetate implant products (notably the histrelin acetate 50 mg implant used for prostate cancer and gender dysphoria indications). Supply chain control is concentrated in the original branded product manufacturer and a limited set of implant system and sterile drug-product manufacturers.

Who are the main suppliers for histrelin acetate 50 mg implant in the US?

The branded histrelin acetate implant product is the core commercial supply reference in the US market: Vantas (histrelin acetate) 50 mg implant. Vantas is marketed by AbbVie in the US.

Key commercial supply entity

• Brand: Vantas (histrelin acetate) 50 mg implant
• US marketing labeler/manufacturer in commercial references: AbbVie

Drug product vs. device vs. raw material

For histrelin acetate implants, upstream “supplier” roles typically split into:

1. API manufacturer (histrelin acetate synthesis and purification)
2. sterile drug-product manufacturer (implant fill, sterilization strategy, aseptic controls)
3. implant/delivery system manufacturer (implant core, housing components, device integration)
4. packager/labeler and importer-of-record (final US release and distribution)

In the US, the public-facing supplier identity is usually most clearly visible at the drug-product and labeler level (Orange Book and FDA product labeling). For implant systems, device integration often sits behind contractor arrangements.

What is the Orange Book status of histrelin acetate implants (Vantas)?

Orange Book status drives the IP and generic entry map. Vantas (histrelin acetate 50 mg implant) is listed as an approved drug product in the US FDA Orange Book with associated patent entries (drug substance and/or drug product and use claims depending on the listing record). Orange Book listings also indicate whether any ANDA or 505(b)(2) generic approach exists for histrelin acetate implants.

What users typically check

• Active patent listings tied to Vantas
• Listed drug status and dosage form scope
• Any pending generic submissions or Paragraph IV certifications
• Orange Book “drug product” codes and strengths

(Orange Book record details are required to enumerate specific listed patents by number and expiration date.)

Which companies supply histrelin acetate API to implant manufacturers?

Public documentation usually does not list the full universe of histrelin acetate API suppliers at the generic level. When API suppliers are disclosed, it is generally through:

• contract manufacturing and tolling arrangements
• DMF-linked information (not always public in a supplier-specific way)
• inspections or consent decree records in limited cases

In practice, “histrelin acetate API supplier” identification is typically constrained to:

• the branded drug’s vertically integrated supply chain
• contract API producers with confidentiality protections
• company-specific DMF access arrangements

Are there generic or biosimilar histrelin acetate suppliers besides AbbVie’s Vantas?

Histrelin acetate is a small-molecule drug (not a biologic), so biosimilar pathways do not apply. The supplier landscape is therefore shaped by whether generic implant products exist or enter via ANDA or 505(b)(2) routes.

Commercial reality check (implant market structure)

• Implant-based products have higher manufacturing and quality barriers than oral solids.
• Even when the API is widely available, the implant delivery system and sterile manufacturing controls limit credible entrants.
• As a result, supplier count can remain small even when API supply is broader.

What manufacturing and quality barriers affect histrelin acetate implant supply?

Supplier sustainability hinges on the implant-specific manufacturing stack. The main bottlenecks are:

Sterile drug-product and aseptic controls

• implant fill quality and uniformity
• sterilization validation and sterility assurance
• particulate control and container-closure integrity

Device integration and implant mechanics

• consistent implant release kinetics across lots
• implant housing and core material controls
• mechanical performance and implantation compatibility

Stability and shelf-life

• chemical stability of histrelin acetate in the implant formulation
• physical stability of the implant structure during storage
• shipment condition controls

These factors narrow the pool of qualified suppliers that can repeatedly meet FDA expectations.

How do histrelin acetate implant suppliers compare: AbbVie Vantas vs. generic candidates?

A supplier comparison framework for histrelin acetate implants should be built around:

1. Regulatory status
   • NDA holder/labeler
   • ANDA/505(b)(2) status for any competitor
2. Manufacturing footprint
   • sterile manufacturing sites
   • device integration sites
3. Quality record and inspection outcomes
4. Launch and distribution capability
   • distribution network and allocation risk

For Vantas, the marketing labeler is AbbVie. Any additional suppliers depend on whether an FDA-approved generic implant exists and which labelers are listed.

What is the patent and exclusivity landscape for histrelin acetate that can affect supplier availability?

Supplier availability in the US typically ties to:

• whether Vantas remains protected by unexpired patents
• whether generic entrants are blocked or partially authorized through licensing
• whether any settlement agreements exist that limit supply substitution

A full patent estate table requires pulling:

• Orange Book listed patents (numbers, jurisdictions, expiration dates)
• exclusivity codes (if any)
• litigation settlement terms (if any)
  These require source-level enumeration from FDA and court filings.

When do histrelin acetate implant exclusivities/patents expire and when could new suppliers enter?

Entry timing for generic implant suppliers depends on:

• earliest relevant expiration date (primary patent vs. method-of-use vs. formulation vs. device)
• any regulatory exclusivity windows
• market entry conditions after patent expiration

A precise timeline requires the Orange Book patent-by-patent dataset.

What FDA regulatory pathway governs new histrelin acetate implant suppliers?

New histrelin acetate implant products must align to one of these frameworks:

• ANDA (generic approval path) with bioequivalence or relevant bridging to the reference implant
• 505(b)(2) (if using reference and/or literature-based support)
• NDA supplemental changes only if not new product

Implants generally require:

• device integration validation
• sterility assurance and process validation
• stability data supporting shelf-life

Key takeaways

• Histrelin acetate supply in the US is anchored by the branded Vantas implant, marketed by AbbVie.
• “Supplier” in this context often means different roles: API, sterile drug-product manufacturing, and implant/device system integration.
• Generic or additional suppliers depend on FDA approvals and patent/exclusivity conditions reflected in the Orange Book, but precise supplier enumeration beyond AbbVie requires Orange Book and regulatory source extraction.

FAQs

1. Is histrelin acetate a biologic or a small molecule with generic pathways?
   It is a small-molecule drug and follows generic drug approval frameworks such as ANDA, not biosimilar pathways.

2. Do histrelin acetate implant suppliers also provide the implant device housing?
   Often the supply chain separates device integration and drug-product sterile manufacturing into different qualified vendors, though specific contractor structures are not consistently public.

3. What constraints most limit additional histrelin acetate implant suppliers?
   Sterile manufacturing controls, implant delivery-system performance, and validated release kinetics.

4. What documentation best identifies a supplier’s regulatory role for histrelin acetate implants?
   FDA product labeling and Orange Book entries tied to the approved drug product.

5. Can histrelin acetate API be sourced more widely than the implant finished product?
   API supply can be broader than finished sterile implant supply because implant qualification and integration are higher-barrier activities.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Vantas, histrelin acetate). (FDA database).