latanoprost: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-90	1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-92	3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-94	3 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-98	1 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472	NDA	Thea Pharma Inc.	82584-003-30	30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH	2023-07-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Latanoprost is supplied as a generic prostaglandin analog active pharmaceutical ingredient (API) and in finished ophthalmic products (typically 0.005% latanoprost solution). The supplier landscape is dominated by China- and India-based API makers and global ophthalmic packagers/marketers. For sourcing and regulatory planning, the practical supplier universe breaks down into (1) API manufacturers, (2) formulation/sterile fill-finish and packaging partners, and (3) companies filing ANDAs and holding US launch/label rights.

Direct, decision-relevant answer: Latanoprost is widely available through multiple redundant supplier chains for API and sterile ophthalmic solution fill-finish. Your risk is not “availability,” but patent/IP and regulatory compatibility of the specific strength, container system, preservative system, and manufacturing process. If you need one-to-one traceable suppliers for a specific marketed SKU (brand or generic NDC), supplier confirmation must be tied to that product’s FDA application and label/manufacturing site information.

What companies supply latanoprost API (active pharmaceutical ingredient)?

Most latanoprost API suppliers are contract-capable manufacturers selling bulk latanoprost to generic ophthalmic formulators. The API is produced at scale because latanoprost is mature and has extensive generic penetration.

Typical latanoprost API sourcing pattern

China-based specialty chemical firms produce latanoprost intermediates and API under DMF/CEP-style documentation commonly used by downstream generic filers.
India-based generics and fine-chemical API plants supply API to multiple downstream ophthalmic product companies.
Global distributors route API through multiple origin sources, but regulatory filings typically identify the API DMF/letter of access rather than naming a distributor.

How to identify the true API supplier for a target product

For any specific latanoprost ophthalmic solution NDC, the “supplier” is best determined by:

the ANDA (or prior application) describing manufacturing and control, and
the API DMF reference (letter of access), and
site-level manufacturing information for drug substance and drug product.

This approach avoids mis-specifying a distributor as the API maker.

Which manufacturers supply latanoprost ophthalmic solution (finished dosage form) to the US?

Finished-dose supply is fragmented across ANDA filers and sterile manufacturing networks. In the US, latanoprost solutions are commonly produced as sterile eye drops and then packaged into unit-dose or multi-dose bottles with a dropper delivery system depending on the label.

Common finished-product manufacturing roles

ANDA holder / applicant: owns the regulatory filing and label.
Contract sterile manufacturer (fill-finish): produces sterile bulk solution, performs aseptic filling, and packages.
Packaging supplier: provides bottles, droppers, closures, and tamper-evident components matched to regulatory device/compatibility requirements.

Product variants that drive supplier differences

Suppliers can differ by:

Container system (e.g., multi-dose bottle with preservative)
Preservative system (historically benzalkonium chloride in many markets)
Device compatibility (dropper/closure compatibility affects extractables and leachables risk)
Labeling (pediatric indication language and administration instructions can tie to particular NDA/ANDA manufacturing choices)

What is the Orange Book status of latanoprost ophthalmic products and how does it affect sourcing?

Latanoprost is largely a generic-dominated category in the US. Orange Book listings for latanoprost generally reflect patents relevant to specific dosage forms, preservatives, or use claims. For sourcing decisions, the key is to map:

which patents are listed for the specific strength and dosage form, and
whether a given competitor entered via Paragraph IV with an alternative certification.

Why Orange Book status matters for suppliers

Even when API is generic, formulation/process claims can restrict:

certain preservative systems,
specific manufacturing methods,
certain packaging container choices,
and sometimes method-of-use claims (less common for the established ophthalmic use).

For contract supply, the practical issue is whether the product you plan to launch is “safe to make” with a specific manufacturing route.

When do latanoprost patents expire and when do generics/biosimilars enter?

Latanoprost is an established small-molecule drug with multiple generic approvals. The exclusivity and patent timing questions usually matter at the product line level, not the API itself.

Timing questions businesses ask in practice

Which listed patents for a specific ANDA-competitor are still active?
Are there “patent listed for the drug product” that constrain your exact formulation or container?
Did any generic challenger trigger litigation that resulted in exclusivity or design-around requirements?

For latanoprost, the answer tends to be that many supply opportunities already exist, but that new launches must still navigate active listings tied to the chosen product configuration.

Which companies challenge latanoprost via Paragraph IV and what does that imply for supplier risk?

Paragraph IV litigation implies:

the challenger believes relevant patents are invalid, unenforceable, or not infringed, and
the target product has enough market position to justify the legal spend.

Supplier risk lens

If a specific latanoprost SKU is involved in active litigation, it can impact:

availability of “same-as” manufacturing processes from contract partners,
design-around choices (e.g., preservative level or manufacturing method),
willingness of contract manufacturers to support certain equivalence strategies.

How strong is the patent estate for latanoprost ophthalmic solutions?

Patent estate strength for latanoprost is typically moderate-to-weak at the API level due to maturity and generic penetration. Strength is usually tied to:

formulation and drug-product claims (if any remain listed),
device/container compatibility claims in some product contexts,
and method-of-use claims in certain filing strategies.

Decision-relevant mapping

For business planning, strength is evaluated as:

number of active listed patents,
remaining time to expiration,
whether claims are formulation-limited or broad,
historical litigation outcomes and settlements (if any).

What formulations are protected by latanoprost patents (solution composition and preservatives)?

For ophthalmic solutions, formulation protection can track:

drug substance content uniformity and specification,
preservative concentration and type,
pH, tonicity, and buffer system,
excipient package compatibility.

Sourcing implication

Two “0.005% latanoprost” products may still differ in:

preservative system,
buffer composition,
container closure system,
and manufacturing process parameters.

Those differences can change patent risk, stability, and shelf life.

What generic entry risks exist for a new latanoprost ophthalmic solution launch?

Primary entry risks are regulatory and patent-compatibility, not API availability.

Regulatory/CMC risks

Sterile manufacturing capability for ophthalmic solution at scale
Stability and preservative efficacy
Container closure integrity and compatibility (leachables/extractables)
Analytical method transfer and validation

Patent-compatibility risks

Infringement of any formulation/process patents still listed
Design-around feasibility for preservative/excipient systems
Whether your chosen ANDA strategy matches the certification and carve-outs

How does latanoprost sourcing compare with bimatoprost, travoprost, and other prostaglandin analogs?

All prostaglandin analogs have similar market dynamics: established APIs, multiple generics, and sterile fill-finish supply networks. The difference is usually patent history by specific product configuration and whether there are active method-of-use or drug-product listings at the target time.

Practical comparison for procurement

If you already qualify sterile ophthalmic fill-finish suppliers for latanoprost, they often support multiple prostaglandin analogs.
The biggest differentiator is formulation and container compatibility, not API supply.

Key supplier and supply-chain checklist for latanoprost

Use this checklist to build a defensible, litigation-aware sourcing plan:

API documentation: confirm the referenced DMF/letter of access for the exact API grade used.
Sterile fill-finish site: confirm aseptic processing competency for ophthalmic solutions, including environmental controls and batch release testing.
Container-closure match: confirm bottle/closure compatibility and extractables profile aligned to your label.
Preservative system: lock the preservative type and concentration to the intended specification.
Stability package: confirm stability protocols for the chosen container.
Regulatory alignment: map manufacturing sites and process to the ANDA strategy and certification route.

Key Takeaways

Latanoprost has a mature, highly supplyable API and finished-dose market, with multiple redundant sources for both API and sterile ophthalmic fill-finish.
Supplier “availability” is rarely the constraint; product configuration and regulatory/patent compatibility are.
For sourcing, the reliable method is linking each NDC/ANDA to the cited API DMF (or letter of access) and to the drug-product manufacturing sites.
Procurement and R&D should treat preservative system, pH/buffer composition, and container-closure compatibility as the main drivers of both CMC risk and patent-compatibility risk.

FAQs

1) Who are the biggest latanoprost API manufacturers by global volume?

No single manufacturer dominates exclusively; API is produced across multiple plants primarily in China and India, with downstream distribution via multiple regulatory filings.

2) Can the same contract manufacturer make latanoprost and other prostaglandin analogs?

Often yes for sterile fill-finish, but formulation, preservative system, and container-closure qualification must be specific to each SKU.

3) What CMC items most often delay latanoprost ANDAs?

Container-closure compatibility, preservative system validation, sterility assurance, and method transfer for assay/impurities are common friction points.

4) Does changing the bottle or preservative create patent or regulatory risk?

Yes. Changes can require new comparability/stability data and can affect infringement analysis if drug-product/formulation patents are listed.

5) Is latanoprost API supply typically constrained during shortages?

Supply is generally stable for a mature generic active, but specific grade or DMF-committed supply can be constrained depending on plant utilization cycles.

References

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

Suppliers and packagers for generic pharmaceutical drug: latanoprost

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