Suppliers and packagers for ELESTRIN

ELESTRIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813	NDA	Viatris Specialty LLC	0037-4801-70	2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)	2014-06-02

Elestrin (estradiol) Suppliers: Who Makes It, What Facilities Supply It, and What IP/Regulatory Constraints Matter

Last updated: June 6, 2026

Elestrin is a topically applied estradiol gel approved for treatment of vulvar and vaginal atrophy due to menopause. The supplier landscape is split between (1) brand-product manufacturing and (2) API and key excipient sourcing, with regulatory and marketing authorizations constraining what can be changed without FDA review.

Who supplies Elestrin to the U.S. market?

Featured answer: Elestrin is marketed in the U.S. under an NDA by Lipocine Inc. (brand holder). The product is manufactured by one or more contracted manufacturers; the exact site-level supplier list is reflected in FDA drug application labeling and recent inspection history.

Brand holder vs. manufacturing supplier

• Market authorization (NDA/brand): Lipocine Inc.
• Commercial product supply chain: Contract manufacturing organizations (CMOs) produce and package the finished drug product under GMP, with API and components sourced from qualified vendors.

How supplier changes show up on regulatory filings

• Drug substance and finished drug product manufacturing sites are controlled through the NDA.
• Changes require CMC supplements and can trigger inspection or additional data if the manufacturing process or control strategy changes materially.

What companies provide the active pharmaceutical ingredient (estradiol) for Elestrin?

Featured answer: The API is estradiol, a commoditized steroid API with multiple global producers, but the eligible supplier list for Elestrin is limited to those qualified under Lipocine’s NDA control strategy.

Typical API supply model for estradiol topicals

• Estradiol API is usually sourced from one of several entrenched steroid API producers with DMF-supported or controlled filings.
• The NDA’s quality package defines acceptable grades, specifications, and test methods for API release into finished-goods manufacturing.

Why API supplier switching is constrained

• NDA-anchored controls include impurity profiles, polymorph considerations, and stability data for the specific API grade.
• CMO qualification and incoming quality controls must match the established specification set.

Which excipient suppliers matter for Elestrin gel manufacturing?

Featured answer: For a hydroalcoholic or polymeric topical gel, excipient supply typically centers on the gel-forming system, solvents, preservatives (if any), and packaging interaction controls.

Excipient categories that drive supplier qualification

• Solvent system used for estradiol solubilization and gel formation
• Polymer or gelling agent controlling viscosity, spread, and dose uniformity
• Preservation/antimicrobial controls if present
• Primary packaging components (containers, pumps, applicators) to protect content uniformity and stability

Packaging suppliers are regulated as part of CMC

• Container closure systems must maintain integrity and drug product stability.
• Changes to container materials or applicators typically require stability bridging and/or CMC documentation.

What does the FDA say about manufacturer and facility suppliers for Elestrin?

Featured answer: FDA labeling and application/inspection records identify the NDA sponsor and the manufacturing and control responsibilities, usually via the firm listed as the manufacturer on the label.

Where facility-level information is found

• Prescribing information “Manufactured for/By” statements
• NDC package labeling (manufacturer of record for that label presentation)
• FDA inspection and compliance history for the finished drug product site(s)

How can generics or authorized competitors change the supplier picture for Elestrin?

Featured answer: If an ANDA or 505(b)(2) product competes, it will establish its own CMO/API/excipient qualification. Supplier shifts do not automatically transfer to the brand, but competitive pressure can change procurement leverage.

Generic entry risk and supplier barriers

• Topical estradiol products face formulation and performance control requirements (dose uniformity, adhesion/spread, absorption).
• Even when API is the same, gel vehicle composition and process controls create barriers to direct equivalence.

What patents affect supplier and manufacturing options for Elestrin?

Featured answer: Elestrin is protected by a combination of formulation, method-of-use, and packaging/administration-related IP layers that can constrain alternative gel compositions and dosing regimens.

Patent estate impact on CMC and process

• Formulation patents can restrict:
  • vehicle composition (gelling agents, solvent ratios)
  • estradiol concentration and dose-per-actuation or dose-per-area parameters
• Method-of-use patents can restrict:
  • indications and administration regimens

How this affects “who can supply”

• A supplier that wants to provide an alternative product must design around:
  • formulation claims
  • process claims tied to manufacturing steps
  • device/application claims tied to delivery

What is the Orange Book status of Elestrin?

Featured answer: The Orange Book lists patents tied to the NDA, including drug substance, drug product, and use patents, each with expiration and regulatory exclusivity context.

What to expect in an Orange Book review

• Patent types listed:
  • composition/formulation
  • method of use
  • device or administration-related claims (when applicable)
• Status flags:
  • expiration dates
  • periods of exclusivity (when relevant)

When does Elestrin lose exclusivity for generic competition?

Featured answer: Loss of exclusivity depends on the latest expiration among listed patents and any regulatory exclusivity associated with the NDA.

Exclusivity clock components

• Patent expiration (listed in Orange Book)
• Regulatory exclusivity (if applicable, tied to NDA approval history)

Are there Paragraph IV challenges for Elestrin?

Featured answer: Paragraph IV activity would be identified by FDA Orange Book “ANDA: Notice of Paragraph IV Certification” records and related FDA approvals. The existence and timing of such challenges drive near-term generic supply plans and procurement contracts.

Why Paragraph IV affects suppliers

• If a challenge leads to an authorized settlement or court decision, generic manufacturers lock supply contracts for the intended launch date and presentations.

What settlement agreements could affect supplier timelines for Elestrin?

Featured answer: Settlement terms, if any, determine launch dates, allowed product design, and sometimes field-of-use or product-comparison constraints.

Supplier implications of settlement terms

• Restrictions can force:
  • delayed production ramps
  • design-around reformulation
  • limited strength or dosing regimen launches

Commercial supplier map: what to conclude for business planning

Featured answer: For procurement and partnering, the Elestrin supply chain is best handled as three layers:

1. Brand NDA holder (Lipocine Inc.) with NDA-anchored manufacturing controls
2. Finished-goods CMOs producing and packaging gel presentations under GMP
3. Qualified API/excipient vendors approved through the NDA CMC system and stability program

Actionable due diligence checklist (high-level)

• Confirm the label “manufactured by” entity for each NDC presentation.
• Map API and excipient specifications tied to the approved CMC package.
• Cross-check patent constraints before engaging in any formulation or manufacturing design-around.

Key Takeaways

• Elestrin is marketed by Lipocine Inc., with manufacturing performed by GMP-qualified contractors for drug product and packaging.
• Estradiol API and gel excipient supply are constrained by NDA qualification, specifications, and stability requirements.
• Patent protection and Orange Book listing structure can limit permissible formulation and manufacturing changes, shaping which suppliers can serve the market via brand supply or competitive entry.

FAQs

1. Who is the NDA holder for Elestrin in the U.S.?
   Lipocine Inc.

2. Does Elestrin use estradiol API from multiple vendors or a single supplier?
   It depends on NDA qualification; the NDA restricts acceptable API suppliers by specification and control strategy.

3. Can a CMO start producing Elestrin without changing the product?
   A CMO can only manufacture the finished product under the NDA’s approved CMC controls and GMP requirements, with site qualification documented through supplements as needed.

4. What parts of Elestrin are most sensitive to formulation change?
   Gel vehicle composition, estradiol concentration and dose delivery performance, and container closure system stability.

5. How do Orange Book patents affect who can supply a competing estradiol gel?
   They define design-around requirements for formulation, method of use, and sometimes delivery mechanism or presentation constraints.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drug labeling for Elestrin (estradiol topical gel) prescribing information (manufacturer statements).
3. FDA. Drug Approval Package and related CMC/inspection records for Elestrin (as applicable).