Last updated: June 17, 2026
Suppliers for Pataday Once Daily Relief (olopatadine ophthalmic)
Pataday Once Daily Relief is supplied in the US as an olopatadine ophthalmic solution product. Key supply-side participants typically include the branded manufacturer/marketer listed on FDA labels, contract manufacturing organizations (CMOs) producing the sterile ophthalmic drug product and packaging, and upstream chemical suppliers providing olopatadine API. The most actionable supplier list must be tied to the specific FDA label/NDC strength and to the Orange Book (and, where applicable, DMF/ASR filings) for the exact product strengths and dosage forms.
Who manufactures Pataday Once Daily Relief (olopatadine) in the US?
Pataday Once Daily Relief is a prescription ophthalmic solution containing olopatadine, an antihistamine/mast-cell stabilizer used for allergic conjunctivitis.
What is the branded company name on the product label?
The “manufacturer” and “packager” entities for Pataday Once Daily Relief are identified on the US FDA labeling (package insert) and on the dispensing label typically associated with each NDC for the specific strength and dosage form.
What roles count as “suppliers” for an ophthalmic sterile solution?
For an ophthalmic sterile product, supplier relationships usually split into:
- Drug substance supplier (olopatadine API)
- Drug product CMO (sterile fill-finish, formulation, filtration/sterilization, QC release)
- Primary packaging supplier (bottles, dropper tips, closures)
- Secondary packaging and distribution (cartoning, labeling, shipping)
- Quality/regulatory supply chain (DMF/ASR holders supporting compendial/approved manufacture)
What companies supply olopatadine API used for Pataday Once Daily Relief?
Upstream olopatadine API suppliers are not reliably inferable from consumer-facing product names. API supply is tracked through FDA submissions (DMFs for drug substance) and quality agreements tied to the NDA holder and each approved manufacturing site.
How to identify API suppliers tied to the US reference product
The only defensible way to name API suppliers is to map:
- The NDA holder for Pataday Once Daily Relief
- The DMF holders referenced in FDA approvals or by site-specific manufacturing in FDA databases
- The manufacturing sites linked to the approved drug substance processes
Which CDMOs/CMOs make Pataday Once Daily Relief sterile ophthalmic solution?
Sterile ophthalmic manufacturing depends on approved fill-finish sites and validated aseptic processing. Those are tied to:
- The NDA’s manufacturing information (drug product manufacturing sites)
- Inspection history and CMC release responsibilities
- Component and packaging specifications
What to look for in manufacturing-site data
For each NDC/strength, determine:
- Approved drug product manufacturing facility name
- Any alternate facilities
- Filling, sterilization, and labeling/packaging sites that appear in FDA records
What does the Orange Book list for Pataday Once Daily Relief suppliers?
The FDA Orange Book lists approved drug products and provides application and exclusivity information, and in some cases links to NDA/ANDA applications, not a full supplier list. For supplier identification, Orange Book is a starting point only.
What the Orange Book can confirm
- The NDA number and product/strength
- Whether the product is listed as an approved drug with patent coverage
- Application ownership and marketed product identifiers
What are the NDC-specific suppliers for Pataday Once Daily Relief (strength-specific)?
“Pataday Once Daily Relief” exists in multiple strengths and presentation variants (often reflected by different NDCs). Supplier attribution must be NDC-specific because different strengths can use different manufacturing and packaging sites.
Why NDC mapping matters
- Different strengths can have different fill-finish and packaging vendors.
- Internal supply chains can change by site without changing the brand name.
How do DMF holders and manufacturing approvals identify Pataday supplier companies?
For sterile ophthalmic drug products, API and certain excipients may be sourced from DMF-supported materials.
DMF-based supplier identification workflow
- Identify the NDA for the branded product
- Retrieve references to DMFs and ASMFs that support the approved material
- Map DMF holder names to supplier entities
- Map manufacturing facility names to drug product release responsibilities
What generic or authorized suppliers compete with Pataday Once Daily Relief supply?
Competition affects supply capacity through:
- ANDA manufacturing networks for generic olopatadine ophthalmic solutions
- Authorized generics (if present) that replicate branded sourcing or use alternative fill-finish sites
How supplier competition typically shifts
- When generic capacity expands, branded and generic sourcing may diverge at the fill-finish level even if API is common.
What supply-chain changes occur after patent or exclusivity events for Pataday?
Supply-chain evolution generally tracks:
- FDA approvals for additional manufacturing sites
- Transfer of manufacturing to alternate CMOs
- Component and packaging vendor changes for cost and capacity
How to tie supply shifts to regulatory milestones
Use:
- FDA manufacturing supplements (CMC)
- Facility additions/changes
- Inspection outcomes impacting approved sites
Key Takeaways
- “Suppliers” for Pataday Once Daily Relief must be defined by role (API vs sterile fill-finish vs packaging) and by NDC/strength.
- The reliable supplier list is derived from FDA-linked records: Orange Book (product identity and NDA mapping) plus DMF/CMC manufacturing site information tied to the NDA holder and approved facilities.
- Without NDC-specific and FDA-record-specific mapping, naming supplier companies risks mixing entities across strengths, presentations, or jurisdictions.
FAQs
- How can I identify the NDC-specific manufacturer for Pataday Once Daily Relief on the FDA label?
- Do Pataday Once Daily Relief’s suppliers differ by strength (NDC) even if the brand name is the same?
- Which FDA databases show drug substance DMF holders for olopatadine used in Pataday?
- What manufacturing-site information indicates the CMOs responsible for sterile fill-finish of ophthalmic products like Pataday?
- How do generic olopatadine ophthalmic ANDAs change the competitive supply landscape versus the branded product?
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). Drugs@FDA: Search for Drug Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). OpenFDA: Drug Product Labeling. U.S. Food and Drug Administration. https://open.fda.gov/
