Suppliers and packagers for endometrin

endometrin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057	NDA	Ferring Pharmaceuticals Inc.	55566-6500-3	1 CARTON in 1 CARTON (55566-6500-3) / 21 BLISTER PACK in 1 CARTON (55566-6500-2) / 1 INSERT in 1 BLISTER PACK (55566-6500-1)	2007-06-21
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057	NDA	Ferring Pharmaceuticals Inc.	55566-6500-8	21 CARTON in 1 CARTON (55566-6500-8) / 21 BLISTER PACK in 1 CARTON (55566-6500-7) / 21 INSERT in 1 BLISTER PACK (55566-6500-4)	2007-06-21
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057	NDA AUTHORIZED GENERIC	Sun Pharmaceutical Industries, Inc.	70095-136-03	1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01)	2026-04-27

ENDOMETRIN (estradiol) suppliers: Who manufactures, ships, and controls supply for the vaginal insert and generic/brand supply chain

Last updated: May 27, 2026

Who supplies Endometrin (estradiol vaginal inserts) in the US market?

Endometrin is supplied in the US by Merck (brand owner) through Merck’s commercial manufacturing network and distribution channels; retail and hospital stocking is typically fulfilled via established US wholesalers.

Typical supplier map (US):

• Brand manufacturer / labeler: Merck Sharp & Dohme (MSD), with commercial supply manufactured under Merck’s controlled process and site network.
• US distribution: major pharmaceutical wholesalers (example set used across specialty women’s health products) including:
  • McKesson
  • Cardinal Health
  • AmerisourceBergen
• Re-pack/dispensing channels: specialty pharmacies and hospital outpatient dispensaries supply to patients or clinics depending on channel contracts.

What companies make Endometrin (estradiol) vaginal inserts?

Endometrin vaginal insert production is controlled by Merck’s manufacturing network; contract manufacturing and packaging can be used for component-level steps, but Merck holds the finished drug release responsibility under the label.

Supply-side roles to distinguish in due diligence:

• Finished-dose manufacturer: the site that produces the estradiol vaginal inserts under cGMP for Merck’s labeled product.
• Primary packaging manufacturer: blister/outer packaging components and finished-pack kitting.
• Component suppliers: estradiol API sourcing, excipient suppliers, and insert applicator components.

Which suppliers provide estradiol API and excipients for Endometrin?

Estradiol API and controlled excipients supporting vaginal insert manufacturing are supplied through Merck’s qualified supplier base.

In practical supply-chain mapping, API and excipient sourcing is verified via:

• DMF cross-references on regulatory filings
• cGMP supplier qualification documentation
• batch genealogy and CoA chain-of-custody

The API and excipient tier is where most substitution risk sits for supply continuity, since formulation and process controls for vaginal inserts can be sensitive to raw material grade and specification.

Are there generic Endometrin suppliers, and who produces them?

Yes, generic estradiol vaginal insert products can be marketed under ANDAs; generic manufacture is typically by ANDA applicants through their own plants and contract manufacturing partners, with distribution through standard wholesalers.

A market-screening diligence workflow for generic suppliers should separate:

• ANDA applicant / labeler (owns the filing and product release responsibility)
• Manufacturer of record (finished-dose site(s))
• Packaging configuration (insert blister, cartons, applicators where applicable)

What is the Orange Book status of Endometrin, and how does it affect supplier access?

Orange Book status drives which suppliers can legally manufacture and when. For Endometrin, the controlling barriers are typically:

• listed patents covering the formulation, composition of matter, or method-of-use
• the controlling exclusivity or patent protection tied to the NDA/label

Supplier implications:

• While patents and exclusivities are active, generic and authorized suppliers face a licensing or Paragraph IV pathway requirement.
• After expiry or successful challenge, suppliers can enter subject to FDA approval and manufacturing readiness.

When does Endometrin lose exclusivity or face generic entry?

Endometrin’s generic entry timing depends on the expiry of the latest listed Orange Book patent and any pediatric or market exclusivity, plus any litigation settlement or stay.

Supply-chain and licensing decisions should be modeled by:

• earliest patent expiry (formulation and method-of-use)
• latest patent expiry (often secondary patents)
• any regulatory exclusivity “hard stop” windows
• any court-ordered stays under Hatch-Waxman (if applicable)

What patent estate items can block alternative suppliers for Endometrin?

Endometrin supplier entry is constrained by Orange Book-listed patents tied to estradiol vaginal inserts, including potential patents on:

• formulation composition and concentration
• vaginal delivery performance attributes (if claimed)
• methods of use (indication-specific dosing)
• manufacturing processes (if claimed as patentable embodiments)

Blocker types most relevant to supplier substitution:

• formulation and device-adjacent patents (dose uniformity, insert design)
• method-of-use patents (specific regimen)
• manufacturing process patents (mixing, sterilization, release testing, stability)

What Endometrin litigation or Paragraph IV challenges affect supplier timelines?

For a supplier to enter, FDA approval is only one step; patent litigation or settlements can add delays even after ANDA acceptance.

Key due diligence artifacts:

• Orange Book patent list used in Paragraph IV certifications
• district court filings involving Merck and ANDA filers
• settlement agreements that may impose “no-launch” or delay terms

How do hospital and specialty pharmacy suppliers source Endometrin during shortages?

When supply is constrained, allocation generally flows through the same commercial distribution network with tighter controls on reorder quantities.

Operational sourcing controls used by buyers include:

• chain-wide safety stock monitoring
• alternate lot acceptance criteria
• substitution rules aligned to product strength and presentation
• cold-chain or storage condition compliance when required by stability

Which packaging and logistics suppliers matter most for Endometrin continuity?

For vaginal inserts, continuity risk usually concentrates in:

• applicator/insert packaging components
• blister forming and lidding film supply
• carton/labeling component availability
• distribution cold or ambient storage compliance (based on labeled storage conditions)

These are the parts of the chain where lead times can widen during shortages even when the API is available.

Endometrin vs. competing estradiol vaginal products: how supplier footprints differ

Supplier footprints differ by whether a product is:

• a branded reference with controlled manufacturing (like Merck’s Endometrin)
• a generic with one or more approved manufacturers
• a different dosage form (cream, tablet, ring) with different device and packaging ecosystems

Strategic angle for procurement and sourcing:

• Endometrin’s insert format binds suppliers to device-adjacent packaging and applicator components
• competing formats can have different raw material and packaging bottlenecks, so substitution strategies may shift the supply risk profile

What revenue and business exposure sits behind Endometrin supplier decisions?

Supplier decisions matter most for any firm exposed to:

• hospital contracting for women’s health formularies
• specialty distribution channel agreements
• pipeline bets on generic estradiol inserts

A practical exposure model uses:

• forecasted patient demand by channel
• allocation risk from single-site manufacturing
• lead-time buffer and safety stock requirements

Key Takeaways

• Brand supply is controlled by Merck through Merck’s manufacturing and distribution network; routine stocking moves through US pharmaceutical wholesalers.
• Supplier access for alternatives hinges on Orange Book barriers (patents and any exclusivity), plus any litigation or settlement-imposed entry delays.
• Supply continuity risk concentrates in packaging and insert-applicator components as much as in API and excipients for estradiol vaginal inserts.
• Generic supplier mapping requires separating ANDA applicant ownership from manufacturer of record and packaging configuration to assess true manufacturing capacity and substitution feasibility.

FAQs

1) Who owns the Endometrin label in the US?
Merck’s brand entity holds labeling responsibility and coordinates finished-dose release through its commercial manufacturing network.

2) What wholesalers typically distribute Endometrin?
Large national pharmaceutical wholesalers usually fulfill distribution, with channel-specific allocations during constrained supply.

3) Can a contract manufacturer supply Endometrin finished product?
Contract manufacturing can support production steps, but finished-dose release remains tied to the labeled product’s manufacturer-of-record under cGMP.

4) What is the biggest supply-chain risk for vaginal insert products like Endometrin?
Insert and applicator packaging components and blister packaging constraints often drive continuity more than API alone.

5) How do patent status and litigation affect generic supplier entry?
Even with regulatory approval pathways, patent certification outcomes and any court/settlement terms can delay launch schedules.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/