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Suppliers and packagers for fareston
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fareston
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin | FARESTON | toremifene citrate | TABLET;ORAL | 020497 | NDA | Kyowa Kirin, Inc. | 42747-327-30 | 30 TABLET in 1 BOTTLE (42747-327-30) | 1997-06-30 |
| Kyowa Kirin | FARESTON | toremifene citrate | TABLET;ORAL | 020497 | NDA | Kyowa Kirin, Inc. | 42747-327-72 | 7 TABLET in 1 BLISTER PACK (42747-327-72) | 1997-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
FARESTON (Toremifene) Suppliers: Who Manufactures, Who Distributes, and What IP/Exclusivity Constraints Shape the Supply Chain
Executive summary: FARESTON is toremifene citrate, a non-steroidal selective estrogen receptor modulator (SERM). The product’s US supply is tied to the approved NDA holder and its labeled manufacturing network, with downstream supplier roles typically split between (1) drug substance and finished-dose manufacturers, (2) contract manufacturing and packaging sites for commercial lots, and (3) wholesalers and pharmacy distribution channels. Patent and exclusivity status affects who can introduce “new” competing versions and when, but it generally does not block routine sourcing of generics marketed by established distributors.
Which companies supply FARESTON (toremifene citrate) in the US?
Answer: FARESTON is supplied via the FDA-approved NDA product chain that includes the NDA holder plus the labeled manufacturers for drug substance and finished drug (tablet manufacture and packaging). Commercial distribution into US channels is handled by authorized wholesalers and pharmacy distribution networks.
What roles exist in the FARESTON supply chain?
- NDA holder / applicant
- Owns the approved labeling and is responsible for commercial supply under the NDA.
- Drug substance manufacturer
- Produces toremifene citrate active ingredient (or an intermediate) used by finished-dose manufacturers.
- Finished dosage form manufacturer
- Produces toremifene citrate tablets (blend, compression, coating) and releases finished lots.
- Packaging and labeling manufacturer
- Packages in bottles/blisters and applies NDC-associated labeling.
- Wholesalers and distribution partners
- Move product to distributors, health systems, PBMs, and retail pharmacies.
How to identify the labeled “suppliers” (manufacturing sites) for FARESTON
The definitive supplier list is the FDA-reviewed manufacturing information and the product’s listing data that ties each NDC to:
- drug substance manufacturing site(s),
- finished dose manufacturing site(s),
- packaging/labeling site(s),
- and lot-release responsibilities.
(If you need the exact company-and-site roster, it must be pulled from the current FDA product label and Orange Book/NDA manufacturing attachments for the specific FARESTON strength and dosage form.)
What patents protect FARESTON and how do they affect supply sourcing?
Answer: FARESTON’s core IP umbrella typically covers the drug (toremifene), then secondary layers such as method-of-use and formulation-specific patents if applicable. These patents influence generic entry timing and any authorized competing formulations, but do not normally prevent wholesalers from distributing whichever lawful versions are on-label.
How long does exclusivity last for toremifene citrate?
- FARESTON’s active ingredient is not a new molecular entity in the US.
- As a result, exclusivity would be historical (patent-driven, not NCE/5-year exclusivity-driven) and generic entry is governed mainly by patent expiration and any Paragraph IV litigation outcomes tied to an abbreviated pathway.
What is the Orange Book status of FARESTON?
Answer: The Orange Book lists the patents associated with the FDA-approved NDA for toremifene citrate and their expiration dates. Those listings determine whether generic applicants face:
- statutory patent barriers under 21 USC §355,
- or litigation risk if they file Paragraph IV certifications.
When do generics or authorized competitors affect FARESTON “supplier” dynamics?
Answer: Generic entry changes the supplier market by adding additional manufacturing capacity and additional NDCs (often multiple strengths/dosage form listings). Wholesalers then source from the most cost-effective legally marketed version.
What generic entry risks exist for toremifene citrate?
Risks generally include:
- Paragraph IV patent litigation for Orange Book-listed patents,
- injunction risk (temporary or permanent) depending on litigation outcomes and settlement terms,
- label carve-outs and modified indications (if any).
What happens in a typical settlement scenario?
Settlements between NDA holders and Paragraph IV filers usually produce:
- a defined “launch date” (often tied to a patent expiry or agreed earlier date),
- limits on product strength(s), dosage form(s), or label language,
- and sometimes shared licensing for specific claims.
What formulations of FARESTON are supplied, and does formulation IP change supplier eligibility?
Answer: FARESTON is marketed as an oral tablet containing toremifene citrate (strength varies by market). Formulation patents matter only for:
- tablet composition and coating systems,
- dissolution/bioavailability-enhancing technologies,
- or manufacturing methods.
If there are no active formulation patents, generic suppliers can use standard pharmacopeial approaches for the tablet.
Key formulation topics that typically appear in relevant patent families
- Tablet core composition and excipients
- Film coating composition
- Particle size and polymorph control
- Manufacturing method-of-making and controls
- Dissolution specifications and process parameters
Which companies challenge FARESTON via Paragraph IV?
Answer: Paragraph IV challengers are those who file an ANDA (or 505(b)(2) where applicable) certifying that Orange Book patents are invalid, unenforceable, or will not be infringed.
To name specific challengers and case captions, the Orange Book patent list and FDA ANDA approval/litigation records must be matched to docketed district court cases.
What FDA pathway regulates FARESTON, and does it change supplier status?
Answer: FARESTON is an FDA-approved NDA drug product for an approved indication. Competitors typically use:
- ANDA (generic) under 505(j), or
- sometimes 505(b)(2) if there is a formulation/device change or bridging approach.
Does 505(j) affect manufacturing supplier requirements?
Yes, indirectly:
- ANDA applicants must show sameness in active ingredient, strength, dosage form, route, and (for generics) bioequivalence.
- Manufacturing quality systems under cGMP are required, so suppliers are qualified through inspection and CMC review.
How does FARESTON supply compare with other SERMs?
Answer: Competitive SERMs (tamoxifen, raloxifene, toremifene products) tend to have overlapping supplier ecosystems:
- common contract manufacturing networks for oral tablets,
- shared excipient and packaging suppliers,
- and similar distributor channels.
The difference is primarily the IP and the number of authorized generic entries at a given time, which changes the number of NDCs and the number of finished-dose suppliers.
Supplier switching: what drives who gets sourced for FARESTON?
Answer: Sourcing is driven by availability, allocation status, lot acceptance, pricing, and regulatory compliance. Patent status influences when new entrants can appear, but day-to-day wholesaler sourcing is procurement-driven.
Procurement triggers that affect supplier selection
- FDA warning letters or CGMP 483 histories (if any at a manufacturing site)
- Sterility is not relevant (oral tablets), but tablet quality, dissolution profile, and stability are
- Lead times tied to commercial packaging calendars
- Backorder patterns and allocation policies in wholesaler systems
Commercial exposure: how much revenue depends on supplier capacity?
Answer: The revenue exposure is tied to:
- number of legally marketed NDCs (more NDCs typically reduce allocation risk),
- extent of generic competition,
- and payer coverage patterns.
With toremifene already mature, supplier capacity typically becomes a logistics and compliance issue rather than a patent-driven bottleneck.
Key Takeaways
- FARESTON supply is determined by the FDA-approved NDA manufacturing and packaging network for each marketed strength and NDC, then distributed through authorized wholesaler channels.
- IP affects when new generic suppliers can enter, but it usually does not constrain distribution of already-approved lawful versions.
- The Orange Book patent list controls Paragraph IV and launch timing; identifying challengers and suppliers requires matching Orange Book/NDA data to FDA filings and docketed litigation.
- Formulation patents matter only if active; otherwise, multiple generic tablet manufacturers can supply the market.
FAQs
-
What is the most reliable way to list the current manufacturing suppliers for FARESTON?
Use the FDA label “Manufactured for”/“Distributed by” and the FDA Orange Book/NDA product details tied to the specific strength and NDC. -
Do FARESTON suppliers change based on tablet strength (e.g., 10 mg vs other strengths)?
Yes. Different strengths can have different labeled manufacturing or packaging sites by NDC. -
Can wholesalers sell FARESTON from any manufacturer if it is FDA-approved?
Wholesalers can distribute FDA-approved versions within the market, but supply depends on product availability and NDC-level lawful marketing. -
How does an ANDA Paragraph IV for toremifene citrate affect who supplies the drug?
It can add a new approved generic NDC after any litigation/settlement constraints, expanding the set of finished-dose manufacturers. -
Does manufacturing supplier qualification require special testing for toremifene tablets?
Qualification centers on cGMP compliance and product quality attributes, including dissolution and stability, plus bioequivalence for ANDAs.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Label: FARESTON (toremifene citrate) Prescribing Information.
- U.S. Food and Drug Administration. ANDA and 505(j) regulatory framework (FDA guidance and statutory references).
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