Suppliers and packagers for binosto

binosto

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344	NDA	Radius Health, Inc.	70539-400-04	4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	2012-03-12
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344	NDA	Radius Health, Inc.	70539-400-94	4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	2012-03-12

Binosto suppliers: who manufactures, supplies, and distributes this bisphosphonate in the US and key export markets?

Last updated: May 27, 2026

Who supplies Binosto (alendronic acid) in the US, and what’s the Orange Book status?

Binosto is the U.S.-market brand of alendronic acid (active ingredient) for osteoporosis treatment. Market supply typically involves three layers: (1) drug substance and drug product manufacturing, (2) finished-goods release and packaging, and (3) wholesaler/distribution.

Orange Book status: Binosto is listed in the FDA Orange Book under the brand name BINOSTO (alendronate sodium). The controlling IP landscape is determined by the Orange Book patent listings tied to the relevant dosage forms and NDA.

What to look up on the Orange Book listing (for supplier diligence):

• Applicant/Holder for the NDA (controls regulatory ownership)
• Manufacturing sites listed under “Manufacturing/Testing facilities” for the NDA
• Patent numbers tied to the listed dosage form(s)
• Exclusivity periods tied to the NDA and any supplements

Which companies manufacture Binosto drug product and packaging, and where are the facilities?

In the absence of a manufacturer-specific dossier, supplier identification must be grounded in the NDA record and commercial labeling. For supplier mapping, the operational sources are:

• FDA NDA labeling sections: “Manufactured for” / “Distributed by”
• FDA Orange Book NDA record: manufacturing/testing sites
• FDA prescribing information (US label): applicant/holder and distributor language
• Establishment inspection and compliance footprint for the manufacturing sites referenced in the NDA

Typical supplier structure for a bisphosphonate brand like Binosto:

• Primary NDA drug product manufacturer: listed in the NDA labeling under manufacturing/packaging language
• Secondary packager: may be involved if the dosage form is blistered/sacheted and the packaging plant differs from the bulk-manufacturing plant
• 3PL logistics and wholesaler distribution: handled by national distributors with assignment to regional service networks

What are the main Binosto dosage forms and how does that affect sourcing?

Binosto is an orally administered bisphosphonate with an emphasis on a patient-friendly format compared with traditional alendronate tablets. Supplier networks often split by:

• API procurement (alendronic acid/alendronate salt)
• Finished dosage manufacturing (granulation or formulation steps)
• Primary packaging (sachets/blistering formats depend on the approved label)
• Secondary packaging and distribution labeling

If you are qualifying a supply chain partner, confirm that the partner supports:

• The same dosage form (not a different alendronate form)
• The same strengths and equivalent release/packaging format
• The same regulatory source tied to the US NDA record

How can you identify the correct “supplier” for licensing, procurement, and litigation?

For high-stakes workstreams, supplier diligence should distinguish:

1. Regulatory holder (NDA holder): controls FDA submissions, labeling, and Orange Book filings
2. Commercial distributor (label distributor): controls market supply and sales contracting in practice
3. Manufacturing site(s): controls GMP manufacture, batch release, and quality agreements
4. API supplier(s): controls drug substance availability, impurity profile, and change-management

The most direct evidence chain is:

• FDA Orange Book entry for the Binosto NDA
• FDA prescribing information label for manufacturing and distribution wording
• GMP facility identifiers embedded in the NDA manufacturing/testing listings

Which generic and biosimilar risks exist for Binosto supply continuity?

Alendronate is a small-molecule drug, so biosimilar risk does not apply. Generic risk comes from:

• ANDAs with Paragraph IV certifications to Orange Book patents (if any are still listed)
• Formulation or process work-arounds that can challenge composition-of-matter or formulation/process patents
• Exclusivity cliffs tied to first approval, supplements, or patent exclusivity periods

Supplier continuity risk typically rises when:

• A competitor wins a Paragraph IV dispute and launches
• Brand inventory is constrained during supply reallocation or manufacturing changes
• NDA holder changes a manufacturing site and pauses shipments during tech-transfer

What patents protect Binosto and how does that relate to suppliers?

Binosto’s patent estate is reflected in the Orange Book patent listings for its NDA and dosage form. Patent coverage can affect:

• Who can legally supply “AB-rated” generics (through FDA approval)
• Whether a supplier must avoid certain processes or formulation compositions
• Whether contract manufacturers or API vendors face constrained change authority because of protected formulation/process claims

Supplier implication: If you contract with a manufacturer, you need a documented chain that the product is produced to the NDA-approved formulation and in a way that does not trigger infringement exposure for at-scale supply.

When does Binosto lose exclusivity, and what does that mean for supplier switching?

Exclusivity timelines (patent expiry and any exclusivity periods) determine when:

• Generic approvals can convert to commercial launch
• Paragraph IV litigation can settle into authorized launch dates
• NDA holders shift manufacturing or negotiate long-term supply contracts with fewer risk constraints

Operational takeaway: procurement and licensing teams should time contracts against:

• The latest Orange Book patent expiration
• Any regulatory exclusivity end date
• Known litigation schedules tied to Orange Book listings

What is the competitive landscape for Binosto supply: brand vs authorized generics vs wholesalers?

Competitive dynamics for an alendronate brand typically include:

• Multiple generic ANDA entrants after expiry windows
• Wholesalers that distribute both brand and generics
• Contract manufacturers that may supply multiple labels in the same drug class

Supplier strategies differ:

• Brand continuity: maintain tight lot-to-lot quality, stable packaging supply, controlled drug substance sourcing
• Generic supply: optimize cost and scale, compress lead time, qualify alternate packaging lines

Key supplier diligence checklist for Binosto (procurement, licensing, and legal readiness)

Use the Orange Book and label record as the primary facts. For each prospective supplier or distributor, confirm:

• The NDA holder/applicant identity
• The label “manufactured for” and “distributed by” statements
• The manufacturing and testing facility names tied to the NDA
• The dosage form and strength manufactured at the facility
• The batch release and stability testing commitments for the packaging format
• Any planned site change timing that could affect product continuity

Key Takeaways

• Binosto supply in the US is anchored in the Orange Book NDA record and the FDA-approved labeling that specify applicant/holder, distribution wording, and manufacturing/testing facilities.
• Supplier mapping requires separating the regulatory holder, commercial distributor, finished-goods manufacturer, and API source.
• Competitive and legal risk is driven by Orange Book patents and any exclusivity windows, not biosimilar frameworks.

FAQs

1) Who is the NDA holder for Binosto in the Orange Book?
2) Which manufacturing sites does the FDA list for Binosto drug product and packaging?
3) Are there any Paragraph IV ANDA challenges listed against Binosto patents?
4) What is the approved Binosto dosage form that distributors must carry to be product-matched?
5) When is the latest Binosto patent expiration date shown on the Orange Book for the relevant dosage form?

---

References (APA)

1. U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Binosto). https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Binosto prescribing information / label (alendronic acid). https://www.accessdata.fda.gov