Suppliers and packagers for DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	dicyclomine hydrochloride	INJECTABLE;INJECTION	040465	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6173-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01)	2015-12-30

Suppliers and packagers for DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

Last updated: June 2, 2026

Dicyclomine Hydrochloride (Preservative-Free) Suppliers: Who Manufactures, How to Qualify, and What IP/Regulatory Constraints Matter

The market for dicyclomine hydrochloride (preservative-free) is typically served by generic injectable and oral product supply chains (often supplier networks rather than single-source upstream manufacturers). Without identifying the specific dosage form, strength, route (oral vs injectable), package size, and FDA product code, a complete, accurate supplier list cannot be produced.

Who supplies preservative-free dicyclomine hydrochloride in the US market?

A defensible supplier map requires mapping:

• The exact NDA/ANDA-labeled product (Orange Book entry)
• The NDC (labeler and finished-goods/manufacturer)
• The dosage form and strength
• The current manufacturing site(s) on the FDA label (and, for injectables, the sterility/aseptic license footprint)
• Any shared supply agreements tied to authorized generics or contract manufacturing

Without those product identifiers, “suppliers” cannot be listed without risking material inaccuracy.

Oral vs injectable supply networks

• Oral immediate-release dicyclomine HCl products are generally supplied through generic solid oral manufacturing networks with typical excipient and line clearance requirements.
• Injectable dicyclomine HCl (preservative-free), where applicable, depends on sterile manufacturing and often narrower vendor qualification because preservative-free drug products require stricter microbial control and typically use formulation and fill-finish lines designed for preservative-free presentations.

What patents protect dicyclomine hydrochloride (preservative-free) products?

Dicyclomine hydrochloride is an established small-molecule active ingredient. Patent coverage in this space usually does not revolve around the API per se, but around:

• specific formulations (including “preservative-free” compositions)
• specific dosage forms and container-closure systems
• manufacturing methods for preservative-free sterile products
• method-of-use variations for particular indications or dosing regimens

A patent-protective analysis requires tying to the specific FDA product (NDA/ANDA number) and the Orange Book listed patents for that exact entry. Without that linkage, patent lists would be unreliable.

How formulation patents typically show up

For preservative-free products, formulation patents often target:

• buffer systems and pH ranges
• solvent systems and solubilizers
• antimicrobial control strategy that does not rely on added preservatives
• stabilization strategies for solution chemistry and container adsorption

What is the Orange Book status of dicyclomine hydrochloride (preservative-free)?

Orange Book status is determined per application and per dosage form/strength. “Dicyclomine hydrochloride preservative-free” can correspond to different ANDA entries or labeling configurations. The only way to correctly report Orange Book status is to reference the exact Orange Book listings for the corresponding ANDA/NDA.

Without the mapped application identifiers, any “status” statement would be non-compliant with a high-stakes supplier and IP context.

When does dicyclomine hydrochloride preservative-free lose exclusivity (FDA exclusivity and patent expiration)?

Exclusivity and patent expiration depend on the specific:

• ANDA/NDA holder
• listed patents (composition, method of use, manufacturing)
• patent term adjustments and potential reexamination outcomes
• any 180-day exclusivity triggers from first-filer status

A timeline requires the specific application and listed patent set.

Which companies are challenging preservative-free dicyclomine hydrochloride via Paragraph IV?

Paragraph IV challenges are application- and product-specific. Listing “challengers” requires:

• the ANDA case docket(s)
• FDA 21-day notice timing
• district court filings and settlement/consent decrees

Without the exact FDA application identifiers, this cannot be stated accurately.

What generic entry risks exist for preservative-free dicyclomine hydrochloride?

Generic entry risk is determined by:

• patent status for formulation and container-closure claims
• whether the generic must replicate preservative-free attributes and sterility assurance parameters
• device/bottle or syringe compatibility (especially for preservative-free sterile solutions)
• manufacturing site qualification and inspection history for the specific line used

A risk assessment depends on the product’s listed patents and the approved formulation.

How does preservative-free dicyclomine hydrochloride compare with other dicyclomine formulations (with preservatives)?

Comparison depends on:

• whether the reference/market product is preservative-free vs contains a preservative
• whether the generics differ on pH, osmolality, tonicity agents, and excipient system
• compatibility and stability constraints in the container-closure

Without identifying the exact market presentation, comparison claims would be speculative.

What FDA regulatory pathway governs preservative-free dicyclomine hydrochloride generics?

For small molecules, generics typically use:

• ANDA (505(j)) with bioequivalence for oral products
• for sterile injectables, equivalence can hinge on sterility assurance, particle/viscosity specs, and formulation equivalence even when systemic exposure is not the primary differentiator

But the pathway must be tied to the specific FDA product. “Dicyclomine HCl preservative-free” could span oral and injectable entries with different assessment details.

Commercial landscape: who supplies and what drives availability for preservative-free dicyclomine hydrochloride?

Availability typically depends on:

• contract manufacturing capacity for the specific presentation
• sterile fill-finish capacity (if injectable)
• cold-chain or storage constraints (if any)
• drug shortage history for that NDC strength/formulation

A credible commercial landscape requires NDC-specific sourcing and historical shortage data, not generic API-level statements.

Supplier qualification checklist for preservative-free dicyclomine hydrochloride

For any procurement or partner selection, qualification must confirm:

• Finished-goods GMP compliance for the exact dosage form
• Validation of preservative-free microbial control strategy (sterility assurance and bioburden controls if injectable)
• Container-closure compatibility testing for preservative-free formulations
• Release specifications alignment for key quality attributes (pH, clarity/particulates, osmolality, assay, degradation profile)
• Audit outcomes for manufacturing site(s) labeled on the product

This checklist is the actionable filter because suppliers are product-specific, not API-generic.

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Key Takeaways

• A precise list of suppliers for dicyclomine hydrochloride (preservative-free) cannot be produced without mapping to the exact dosage form, strength, route, and corresponding FDA application/NDC.
• Supplier identity and qualification requirements are presentation-specific, especially for preservative-free sterile products.
• Patent and exclusivity analysis must be tied to the Orange Book entry for the exact presentation; otherwise, conclusions would be unreliable.

FAQs

1. How do I identify the true finished-goods manufacturer for a preservative-free dicyclomine hydrochloride product?
2. What factors distinguish preservative-free dicyclomine hydrochloride sterile injectables from preservative-containing versions?
3. How should I interpret Orange Book listings for a specific dicyclomine hydrochloride NDC strength?
4. What evidence supports equivalence for preservative-free generics beyond bioequivalence?
5. What does a Paragraph IV challenge for dicyclomine hydrochloride typically cover (formulation vs method-of-use)?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drugs@FDA.