PRILOSEC: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056	NDA	Covis Pharma US, Inc	70515-610-01	30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01)	2017-08-25
Azurity	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056	NDA	Covis Pharma US, Inc	70515-625-01	30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)	2017-08-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 27, 2026

Prilosec (omeprazole) Suppliers: What companies make bulk API, contract manufacturing, and key finished-dose products

Executive summary: Prilosec is the branded form of omeprazole (a proton pump inhibitor). Supply is a mix of generic and branded finished-dose manufacturers plus multiple global suppliers of omeprazole API and excipients. In the U.S., brand supply has historically come from AstraZeneca-linked branded operations, while ongoing market availability is driven by generic manufacturers that list products on the FDA’s Orange Book. Contract manufacturing and API sourcing are not single-source: the practical supplier landscape is determined by which NDA/ANDA products are on-label and currently marketed, the site-level manufacturing listings, and any patent or exclusivity constraints on particular dosage strengths.

Who supplies Prilosec (omeprazole) in the U.S. market today?

Short answer: “Prilosec supply” is primarily fulfilled through marketed finished-dose products labeled for omeprazole delayed-release. The supplier identity depends on:

which NDC/strength (20 mg vs 10 mg vs 40 mg historically),
whether the product is AstraZeneca’s branded NDA labeling or a generic ANDA,
current FDA marketing status (discontinuations and relaunches happen).

How to map “suppliers” correctly

Use the FDA Orange Book to identify the active NDA/ANDA holders for omeprazole delayed-release at each strength and dosage form.
Cross-reference each product’s manufacturing site(s) via Orange Book “Manufacturers” and label information (if available).

What this means for procurement

Expect multiple parallel supply chains because omeprazole is off-patent in most jurisdictions.
Finished-dose “suppliers” in practice are ANDA holders and their CMOs, while API sources can be several.

Which companies are the typical finished-dose suppliers for omeprazole delayed-release (Prilosec-equivalent)?

Common roles in the supply chain:

Brand holder / marketer: AstraZeneca (Prilosec brand for historical labeling).
Generic manufacturers/ANDA holders: multiple companies with omeprazole delayed-release tablets on the Orange Book, each with one or more manufacturing sites.
Contract manufacturers: CMOs producing tablets for brand and generic labels depending on annual supply and quality strategy.

Does “Prilosec supplier” mean API or finished tablets?

In procurement contexts, it can mean either. In most industrial sourcing workflows:

API supplier: global chemical/API manufacturers supplying omeprazole bulk drug substance.
Drug product supplier: tablet manufacturer or CMO preparing enteric-coated omeprazole delayed-release tablets (the commercially marketed form).

Because the request is “suppliers,” the actionable view is to treat the supply chain as two layers: API and finished-dose.

What API suppliers make omeprazole (bulk drug substance) for Prilosec and generics?

Short answer: Omeprazole API supply is fragmented across multiple global API producers. The API supply chain is not standardized to one company because omeprazole is widely manufactured for generics.

Where API supplier identification comes from

Orange Book lists finished-dose manufacturer(s), not always the API site.
The most reliable supplier mapping typically comes from:
- DMF/DMF referencing (where applicable),
- quality agreements and supplier audits,
- and manufacturer label/packaging disclosures for drug product sites (not always API).

What excipients and dosage-form suppliers matter for omeprazole delayed-release tablets?

Key formulation inputs for enteric-delayed products generally include:

enteric coating polymers (often methacrylic acid copolymer-based systems)
acid-resistant film-coating components
tablet excipients (binders, fillers, disintegrants, lubricants) Those are usually sourced from specialized chemical/excipient suppliers supporting multiple tablet formulators and CMOs.

How do you identify the exact Prilosec (omeprazole) manufacturers by NDC and strength?

Short answer: Supplier-by-NDC is the cleanest approach. Each NDC maps to a specific product labeler and often a specific manufacturing site.

Method

Select the dose/strength (for Prilosec equivalents: typically 20 mg, and other strengths as marketed).
Pull the corresponding Orange Book entry for omeprazole delayed-release.
Extract:
- Application holder (NDA/ANDA),
- listed manufacturing sites (where present),
- dosage form.
Validate with current labeler/marketing status on FDA listing and the distributor chain.

Which companies have Orange Book listings for omeprazole delayed-release?

Short answer: Orange Book listings are held by multiple ANDA applicants and historically the brand NDA. The exact company list must be pulled directly from the Orange Book for omeprazole delayed-release because assignments change, products get withdrawn, and new ANDAs get approved over time.

What is the practical supplier landscape when selecting an omeprazole tablet source?

Procurement teams usually maintain a supplier matrix:

Drug product: ANDA labeler and CMO
Packaging: bottle/blister supplier (often separate)
API: qualified API vendor
Coating systems and excipient vendors (as part of change control)

Because multiple ANDA suppliers exist, switching between qualified sources is typically feasible for omeprazole delayed-release tablets.

When does Prilosec lose exclusivity and how does that affect supplier entry?

Short answer: Branded exclusivity and patents around early Prilosec (omeprazole) are long expired, so entry is not constrained in the U.S. for most omeprazole delayed-release strengths. The current competitive supplier field is dominated by generics.

Business impact

After exclusivity and patent expiration, supply expands: more ANDA approvals, more manufacturing sites, and price pressure.
For procurement, the main “entry risk” is not legal. It is operational: manufacturing capacity, quality events, and supply disruptions.

What patent landscape affects omeprazole suppliers (finished-dose and formulations)?

Short answer: For long-supplied products like omeprazole, patent estates are usually limited to specific:

formulation/process variants,
method-of-use claims,
or later life-cycle changes for specific dosage strengths or variants.

Supplier entry in omeprazole is typically already past major regulatory bottlenecks due to long availability.

Do generic entry and Paragraph IV challenges matter for omeprazole?

For a mature drug like omeprazole, most market events are not tied to new Paragraph IV challenges.
The more relevant supplier constraints are quality, capacity, and regulatory compliance for the marketed dosage form.

How many manufacturing sites supply Prilosec-equivalent omeprazole tablets?

Short answer: Multiple. The number is determined by the current Orange Book list of ANDAs with marketed product and their manufacturing sites.

Why this matters

More sites means better redundancy and often better lead times.
It also increases exposure to supply chain variability across sites.

What generic launch scenarios exist for omeprazole when supply tightens?

Short answer: When shortages happen, the limiting factor is usually not patent. It is drug product manufacturing throughput and API availability.

Common shortage response patterns

Increased shipments from alternate ANDA manufacturing sites.
Short-term production runs on alternate packaging configurations.
API reallocation across qualified drug product plants.

What are the key CMO and contract manufacturing constraints for omeprazole tablets?

Short answer: For enteric-coated delayed-release tablets, constraints usually include:

coating line capacity (enteric film coating and drying),
stability and dissolution performance in quality specs,
batch-to-batch variability controls.

Because omeprazole is widely manufactured, the bottlenecks are typically site-level and line-level, not IP-related.

How does Prilosec compare with other omeprazole delayed-release products on sourcing and labeling?

Short answer: In procurement terms, all omeprazole delayed-release products compete on:

strength and release specifications,
excipient profile,
packaging configuration and NDC,
and manufacturing site qualification status.

Branded “Prilosec” is often functionally interchangeable with A-rated generics once regulatory interchangeability and quality criteria are met.

Key Takeaways

“Prilosec suppliers” means both finished-dose tablet manufacturers/labelers and upstream API and excipient suppliers.
In the U.S., supplier identification is best done by NDC and Orange Book entries for omeprazole delayed-release tablets.
The market is multi-supplier because omeprazole is mature and generics dominate.
IP/patent constraints are generally not the main driver of new supply entry for omeprazole; operational capacity and quality controls are.

FAQs

1) What is the Orange Book status of omeprazole delayed-release (Prilosec)?
Orange Book entries exist for the marketed omeprazole delayed-release products; the status varies by specific NDA/ANDA.

2) Which companies hold ANDAs for omeprazole delayed-release tablets?
Multiple ANDA holders list products for omeprazole delayed-release; the current list is determined by the Orange Book.

3) Are omeprazole API suppliers the same across all generic brands?
Not reliably. API sourcing can vary across ANDA manufacturers and through time.

4) What manufacturing sites produce enteric-coated omeprazole tablets?
Manufacturing sites are listed at the drug product level in Orange Book/labeling, and can differ across ANDA holders.

5) What causes omeprazole supply shortages?
Typically upstream API allocation, tablet coating line capacity, and batch-release quality constraints rather than patent barriers.

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA Labeling Resources (DailyMed). https://dailymed.nlm.nih.gov/

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