Suppliers and packagers for lioresal

lioresal

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075	NDA	Amneal Pharmaceuticals LLC	70121-2496-5	5 AMPULE in 1 BOX (70121-2496-5) / 1 mL in 1 AMPULE	2022-06-12
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075	NDA	Amneal Pharmaceuticals LLC	70121-2501-1	1 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE	2022-06-12
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075	NDA	Amneal Pharmaceuticals LLC	70121-2502-2	2 AMPULE in 1 BOX (70121-2502-2) / 1 KIT in 1 AMPULE	2022-06-12

Suppliers for Lioresal (baclofen): manufacturers, contract supply chain, and generic/authorized alternatives

Last updated: May 27, 2026

Executive summary Lioresal is a brand of baclofen (GABA-B receptor agonist) approved for spasticity. In practice, “suppliers” split into (1) the US/NDA marketing authorizations and label holders, (2) FDA-registered manufacturing sites and contract manufacturers for drug substance and drug product, and (3) authorized generic/generic entrants supplying baclofen tablets and baclofen oral suspension. Specific supplier names for lioresal supply chains depend on the labeled product configuration (tablet strength, oral suspension, and pack size), the market (US vs EU/UK), and the period of supply. Without jurisdiction and product form, only partial supplier coverage can be stated.

Who manufactures Lioresal baclofen tablets and oral formulations?

Lioresal is baclofen marketed under the brand name. In regulatory terms, the “supplier” in each market is the company holding the marketing authorization and the companies manufacturing the drug product at FDA-registered facilities (US) or at authorized EU manufacturing sites.

What company is the marketing authorization holder for Lioresal?

The marketing authorization holder (MAH) for Lioresal varies by country and by historical product lifecycle stage. The supplier list used for procurement and pharmacovigilance should align to the current market authorization holder for the specific dosage form.

What does “supplier” mean for pharma purchasing?

For baclofen, procurement teams typically track three layers:

• Label/MAH (brand owner for the marketed presentation)
• Drug product manufacturers (finished-dose manufacturing and packaging)
• Drug substance manufacturers (baclofen API production and, sometimes, crystallization/polishing steps)

What patents protect Lioresal baclofen and how does that affect supplier entry?

Patent protection affects which manufacturers can legally supply branded Lioresal and how quickly generics gain freedom-to-operate.

Do Lioresal baclofen patents block generics?

Baclofen is an older, widely available active ingredient, which typically means branded IP has largely expired in most jurisdictions. Generic supply tends to be driven by regulatory approvals, manufacturing scale, and cost structure rather than active patent exclusivity.

Are there formulation patents for Lioresal presentations?

For a generic supplier strategy, the relevant question is not only the API, but whether any controlled-release, taste-masked oral suspension, or specific manufacturing process patents remain in force for the exact presentation sold under the brand.

What is the Orange Book status of Lioresal baclofen products in the US?

In the US, the key procurement-facing reference is the FDA Orange Book for baclofen products (tablets and any oral suspension), including:

• Listing type (new drug application (NDA) vs abbreviated new drug application (ANDA))
• Patent numbers tied to each strength
• Patent expiration dates and listed exclusivity (if any)
• Exclusivity codes (when present)

Which companies supply generic baclofen tablets and oral suspension?

Because baclofen is widely generic, supplier coverage usually includes multiple ANDA holders and authorized generics across strengths.

How many ANDA suppliers typically exist for baclofen?

Generic baclofen often has multiple ANDA entrants per strength, creating a competitive supplier set. The exact number varies by strength and by whether oral suspension is stocked.

What do buyers screen across generic baclofen suppliers?

Procurement and quality teams typically evaluate:

• FDA-approved ANDA manufacturer(s) by strength
• Current good manufacturing practice status (483 history, recall history)
• Supply reliability (fill rate performance)
• Price and rebate structure
• Packaging configuration and labeling requirements (including lot traceability)

What are the FDA manufacturing and registration implications for baclofen suppliers?

Even when multiple companies “sell” baclofen, manufacturing happens at specific FDA-registered facilities listed on approved applications.

Which manufacturing sites matter most?

For supply continuity, the most actionable supplier data are:

• Drug product manufacturing site (tablet compression, coating, packaging)
• Sterility is not relevant for baclofen tablets, but moisture/particle control and stability are
• For oral suspension, formulation and fill-finish sites (and preservative system controls)

How do contract manufacturers show up in the regulatory record?

Contract manufacturers are typically reflected as drug substance or drug product manufacturers in application databases and facility registrations, not necessarily in public branding.

How do biosimilar rules apply to Lioresal?

No. Lioresal is a small-molecule drug. Biosimilar frameworks do not apply.

What generic entry risks exist for baclofen “brand-like” presentations?

For baclofen, the main entry risk typically is not “patent linkage only,” but:

• Product-specific patent or exclusivity on the exact dosage form
• Bioequivalence performance for certain strengths
• Manufacturing scale-up and stability constraints for liquid formulations

When does Lioresal lose exclusivity for each dosage form?

For baclofen, branded exclusivity is usually long past; generic timelines typically depend on whether any remaining patents or exclusivity are listed for specific strengths and presentations in the Orange Book.

Practical procurement implication

If exclusivity is expired, entry becomes a matter of ANDA readiness, facility capacity, and supply chain execution.

What supplier landscape exists outside the US (EU/UK)?

Europe and the UK usually have national marketing authorizations for baclofen under brand and generic labels. Suppliers shift with:

• National distributor arrangements
• MAH structures
• Tendering cycles (NHS and large hospital group contracts)

Key Takeaways

• “Suppliers for Lioresal” must be defined by market and dosage form because MAHs and manufacturing sites vary.
• In baclofen, the supplier market is dominated by generics/ANDA holders rather than remaining branded exclusivity in most settings.
• The most procurement-relevant supplier intelligence comes from FDA/Orange Book listings (US) and registered manufacturing sites for the exact strength and presentation.

FAQs

1. Who is the MAH for Lioresal in the US versus EU?
2. Which FDA-registered sites manufacture baclofen tablets for ANDA holders?
3. How many ANDA manufacturers supply generic baclofen for a given strength?
4. Do oral suspension versions of baclofen have different supplier/manufacturing sites than tablets?
5. What Orange Book patents, if any, are still listed for specific baclofen strengths?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database). https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm