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Suppliers and packagers for KLONOPIN
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KLONOPIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-605-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10) | 1975-06-02 |
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-610-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10) | 1975-06-02 |
| Cheplapharm | KLONOPIN | clonazepam | TABLET;ORAL | 017533 | NDA | H2-Pharma, LLC | 61269-620-10 | 100 TABLET in 1 BOTTLE, PLASTIC (61269-620-10) | 1975-06-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Klonopin (clonazepam) Suppliers: Who Manufactures, Supplies APIs, and Provides Finished Dosage Across Markets
Klonopin is a branded benzodiazepine (clonazepam) supplied in finished-dose form and supported by API sourcing networks for multiple geographies. The supplier landscape is segmented into (1) finished-dose manufacturers that sell branded product under license/label rights and (2) API producers that provide clonazepam for generic manufacturers and re-packers.
Which companies supply Klonopin (clonazepam) finished tablets and how is supply structured by geography?
Answer: Klonopin finished product supply typically rests with the branded label holder and contract manufacturing/marketing affiliates licensed for regional distribution, while many non-U.S. markets source finished products through local or licensed distributors and manufacturers of record.
Who is the brand holder and label entity in the US?
- Brand/market authorization in the US: Bausch Health US, LLC (Klonopin label)
- Finished-dose supply chain: Bausch Health’s US commercialization is supported by contract manufacturing and internal manufacturing capacity through approved manufacturing sites listed in the FDA label and NDC/labeler data.
How do overseas supply arrangements usually differ?
- Non-US markets often split production and distribution between:
- The marketing authorization holder (MAH) for the branded product
- Licensed distributors for local tendering and hospital channels
- Local finished-dose manufacturers for packaging and labeling, depending on regulatory pathway and market size
What is the Orange Book status of Klonopin and who are the listed manufacturers?
Answer: The Orange Book lists patent and exclusivity information for approved drug products, with application holders and related data; it also helps map manufacturer/labeler footprints indirectly through product listings and FDA approval history.
What you can extract from Orange Book listings
From the Orange Book for clonazepam products (including branded and approved generics), investors and litigators typically identify:
- Application holder (NDA holder where applicable)
- Product-specific listing records
- Switch points for exclusivity and patent-driven transitions
How that maps to “suppliers”
- Branded Klonopin suppliers map to the NDA holder’s commercial label strategy and manufacturing sites approved for that application.
- Generic clonazepam suppliers map to ANDA holders and their associated drug substance and drug product manufacturing sites.
Who supplies clonazepam API (drug substance) for Klonopin and generic manufacturers?
Answer: Clonazepam API is produced by a global set of chemical manufacturers. In practice, branded finished-dose makers buy API directly or via distributors, while generic finished-dose makers often procure API from one or more qualified API suppliers to support multiple manufacturing lines and sites.
API supply structure used by generics
Most generic clonazepam product approvals rely on:
- API manufacturing at one or more qualified sites for drug substance control strategy
- Finished-dose manufacturing sites for drug product control strategy
- Batch release and quality systems aligned to FDA or local GMP regimes
Practical approach for mapping API suppliers
Supplier lists used in licensing, due diligence, and sourcing are typically built from:
- FDA inspection datasets (establishment-level GMP)
- DMF-linked sites for drug substance (where discoverable)
- Generic product manufacturer disclosures in FDA databases and labelers
- Sponsor and supply chain disclosures in litigation records and consent decrees
Which generic clonazepam manufacturers supply the market and compete with Klonopin?
Answer: Multiple ANDA sponsors supply generic clonazepam in the US across strengths and dosage forms, with their own manufacturing sites and labelers.
How to interpret “supplier” in generic competition
For generic clonazepam, “supplier” can mean:
- ANDA holder (brand-independent applicant)
- Finished-dose manufacturing company (GMP site)
- Labeler/distributor on the NDC (who markets the product)
- API producer (upstream drug substance supplier)
Why this matters for procurement and risk
- If you are contracting for supply, the critical constraint is the finished-dose GMP site capacity and its ability to maintain bioequivalence and dissolution specifications
- If you are licensing manufacturing, the critical constraint is whether the API supplier and DMF chain-of-title support continued supply
Which formulations and strengths are supplied for clonazepam products, and what supplier constraints apply?
Answer: Klonopin is supplied as oral tablets in multiple strengths (commercially common strengths include 0.5 mg and 1 mg in the US). Generic products typically cover the same strengths and also may include other tablet presentations depending on market.
Key supply constraints for oral benzodiazepine tablets
- Stability and dissolution control for tablet formulations
- Tablet compression and uniformity specifications
- Dependence on API impurity profile control (nitro and related benzodiazepine impurities)
What patent or regulatory events affect supply continuity for Klonopin suppliers?
Answer: Clonazepam is long off primary origin brand exclusivity in many markets; supply continuity is driven more by regulatory approvals, inspections, and market dynamics than by ongoing exclusivity in the modern era.
FDA exclusivity and patent-driven entry
- In most practical supplier planning, generic entry timing is driven by:
- Orange Book patent expiry
- Any last-minute patent litigation or settlement
- ANDA approval and launch readiness (labeling, packaging, supply commitments)
When do Klonopin and clonazepam generics lose exclusivity and what does that mean for suppliers?
Answer: For branded Klonopin, the key supplier shift occurred after branded exclusivity ended, with sustained generic competition shaping today’s supplier landscape.
Commercial impact
- Higher supplier multiplicity
- More procurement options for wholesalers and group purchasing organizations
- Lower margin per unit relative to exclusivity-era branded dynamics
What Paragraph IV challenges or patent litigations affect clonazepam supplier eligibility?
Answer: Branded benzodiazepine supplier eligibility is most influenced by FDA-approval-driven readiness, while patent litigation affects specific ANDAs and label carve-outs rather than broad “supplier qualification” across the market.
How litigation changes sourcing
- A successful Paragraph IV can accelerate an ANDA launch, increasing supplier counts
- Settlement agreements can delay entry, sustaining branded or early generics’ market share
How does biosimilar risk apply to Klonopin suppliers?
Answer: Biosimilar risk does not apply. Klonopin is a small-molecule drug (clonazepam), not a biologic.
What manufacturing/IP barriers can restrict clonazepam tablet supply?
Answer: For clonazepam tablets, the main barriers are manufacturing capacity and regulatory compliance, not formulation IP for broad small-molecule compositions in the modern generic era.
Common barrier points
- DMF-linked API supply continuity
- Inspection outcomes at drug product and drug substance sites
- Tablet formulation process validation and scale-up transfer
- Supply chain disruptions in solvent, intermediate, and API starting material availability
Which NDC labelers and distributors can be treated as “suppliers” for Klonopin procurement?
Answer: In day-to-day procurement, wholesalers and distributors list by NDC and labeler. The practical approach is to treat:
- NDC labeler/distributor as your “commercial supplier”
- The underlying manufacturer of record as the “regulatory supplier”
What procurement teams typically verify
- Current labeler for each NDC
- Manufacturing site on the package insert/label
- GMP inspection history and recent warning letters (where applicable)
- Lead times and batch-to-batch reliability
Key Takeaways
- Klonopin’s supply is anchored by the US label holder (Bausch Health US, LLC) and supported by approved manufacturing sites for finished tablets.
- “Suppliers” in clonazepam are best understood in layers: finished-dose manufacturers/labelers, and upstream API producers supporting generic supply networks.
- Competitive supply today is dominated by generic clonazepam manufacturers across multiple strengths and tablet presentations, with supply stability driven mainly by GMP compliance and API availability rather than ongoing exclusivity.
- Biosimilar risk does not apply to Klonopin.
FAQs
1) Who is the label holder for Klonopin in the United States?
Bausch Health US, LLC is the US label/brand holder for Klonopin.
2) Are there multiple manufacturers for generic clonazepam in the US?
Yes. Generic clonazepam products are supplied by multiple ANDA holders with multiple finished-dose manufacturing sites and labelers.
3) What does “supplier” mean for clonazepam procurement: API or tablets?
Procurement teams often need both: (a) commercial supplier for NDC delivery and (b) manufacturing site for regulatory and quality assurance.
4) Can biosimilars compete with Klonopin?
No. Klonopin is a small-molecule drug, so the biosimilar pathway does not apply.
5) What are the main risks to clonazepam tablet supply?
GMP compliance at manufacturing sites, API continuity, and approval or launch timing for specific generic ANDAs.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drugs@FDA: Klonopin (clonazepam) label and application details.
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