Suppliers and packagers for PATADAY TWICE DAILY RELIEF

PATADAY TWICE DAILY RELIEF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688	NDA	Alcon Laboratories, Inc.	0065-4274-01	1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC	2020-02-25

Suppliers for PATADAY TWICE DAILY RELIEF (olopatadine ophthalmic solution 0.1% or 0.2%): who manufactures, who supplies, and what to verify in sourcing and regulatory filings

Last updated: June 20, 2026

Executive summary: PATADAY TWICE DAILY RELIEF is a brand of olopatadine ophthalmic solution used for allergic conjunctivitis. Because “PATADAY TWICE DAILY RELIEF” is a consumer-facing name, the supplier landscape must be confirmed through the product’s FDA labeling (NDC-specific), Orange Book reference product entries, and the underlying approved application manufacturing sections. Without those NDC-to-manufacturer linkages, supplier identification cannot be stated accurately.

Which companies supply PATADAY TWICE DAILY RELIEF (olopatadine) to the U.S. market?

Answer (what matters for supplier decisions): The relevant “suppliers” are (1) the NDA holder and brand owner on file with FDA, (2) the listed manufacturer(s) for drug substance and drug product in the approved application, and (3) contract manufacturers named in FDA labeling and inspection records tied to the specific NDC strength and container configuration.

Supplier validation points that determine who can be qualified

• NDC-specific strength and dosage form: PATADAY is sold in different strengths depending on the regimen (commonly 0.1% BID and 0.2% QD across markets). “Twice daily relief” implies a BID schedule but supplier confirmation must match the exact NDC.
• Labeler/holder vs. manufacturer: The labeler on the carton may differ from the manufacturing site named in the FDA application.
• GMP site identity: Supplier qualification for ophthalmics must map to the drug product manufacturing facility and the sterile manufacturing controls referenced in the application.

What does FDA labeling typically list for suppliers?

For an ophthalmic solution, the label generally identifies:

• Brand/holder
• Dosage form and active ingredient
• Manufacturer contact address (sometimes the labeler, sometimes the actual site)
• Storage, lot and distribution information

The binding supplier list for procurement must come from the FDA SPL (Structured Product Labeling) and the approved application manufacturing sections.

What is the Orange Book status of olopatadine ophthalmic solution used as PATADAY TWICE DAILY RELIEF?

Answer: PATADAY is tied to olopatadine ophthalmic solutions. Orange Book status and patent listings vary by NDC and strength. The correct approach is to match the product’s NDC to the Orange Book “Reference Listed Drug” (RLD) entry and then extract patent numbers and expiration dates.

How does Orange Book status affect supplier and generic entry risk?

If PATADAY TWICE DAILY RELIEF’s specific NDC is under active exclusivity or listed patents:

• Authorized generics or branded rebrands may be constrained to settlement or licensing arrangements.
• Contract manufacturing for generics may proceed only if paragraph IV challenges or at-risk launch planning exists for the specific formulation and dosing.

Who are the drug substance suppliers for olopatadine in PATADAY TWICE DAILY RELIEF?

Answer: Drug substance suppliers for olopatadine are typically controlled through the NDA holder’s supply chain and may be listed indirectly through:

• Contract manufacturing disclosures in FDA submission content (not consistently visible in public label data)
• Drug Master File (DMF) references, which are not always public in an easy-to-use way for a brand name search
• Inspectional records tied to manufacturing sites

What to verify for procurement

• Sterility assurance approach: ophthalmics require validated sterilization and aseptic processes appropriate for the product’s form factor.
• Container closure system: compatibility, leachables, and shelf-life requirements can shift supplier qualification even if the API is the same.
• API grade and impurity profile: olopatadine specifications and impurity controls affect formulation stability and regulatory acceptance.

Which contract manufacturers produce ophthalmic sterile solutions like PATADAY TWICE DAILY RELIEF?

Answer: Contract manufacturing for ophthalmic sterile solutions is typically performed by specialized aseptic manufacturing sites. The exact site for PATADAY TWICE DAILY RELIEF is NDC-specific and must be pulled from FDA labeling and, where needed, application manufacturing listings.

Manufacturing site due diligence for sterile ophthalmics

• Aseptic process validation status and batch release testing
• Sterility testing method and environmental monitoring program
• Container closure integrity testing
• Visual inspection controls
• Stability protocol (opened vs unopened stability, if applicable)

What suppliers matter most for “PATADAY TWICE DAILY RELIEF” packaging and distribution?

Answer: For business continuity, supplier focus should include:

• Labeler/holder (U.S. distribution responsibility)
• Finished product manufacturer site
• Packaging and labeling vendor (carton, insert, and compliance markings)
• Logistics distributor

Why packaging vendors can be a procurement bottleneck

Ophthalmic OTC products face:

• Child-resistant or tamper-evident requirements depending on configuration
• NDC barcode requirements and serialization status changes over time
• Global or seasonal distribution planning that can affect lead times

How does PATADAY TWICE DAILY RELIEF sourcing compare with other olopatadine brands (e.g., Pataday Once Daily Relief)?

Answer: The sourcing differences are typically:

• Same API (olopatadine) but different strength and regimen
• Potentially different formulation parameters (concentration, pH targets, buffer system)
• Different NDCs can have different manufacturing sites and packaging suppliers

Supplier impact

Even with the same API, procurement risk can differ because:

• Manufacturing campaign schedules differ by NDC
• Stability and shelf-life requirements differ by concentration
• Sterile manufacturing batches may be prioritized differently

Key Takeaways

• “PATADAY TWICE DAILY RELIEF” supplier mapping is NDC-specific and must be verified via FDA SPL/labeling and the application’s listed manufacturing sites.
• The procurement “supplier set” for this ophthalmic is anchored on the NDA holder/labeler, the finished dose manufacturer, and the aseptic sterile manufacturing facility for the specific strength and container.
• Orange Book status depends on the RLD entry for the matched NDC, which also drives competitive and generic entry risk into supply.

FAQs

1. How do I identify the finished dose manufacturer for a specific PATADAY TWICE DAILY RELIEF NDC?
   Use the NDC in FDA SPL/labeling and extract the manufacturer listed for that exact configuration.

2. Are PATADAY twice daily and once daily manufactured at the same GMP site?
   They can be, but supplier mapping is NDC and application-specific, so it must be confirmed through labeling and manufacturing listings.

3. Do drug substance suppliers for olopatadine differ between brands and strengths?
   They can; olopatadine procurement is often controlled through NDA holder supply chains and linked to specification acceptance for each formulation.

4. Does Orange Book patent status change supplier availability for ophthalmic olopatadine products?
   It can affect generic competition and authorized supply strategies, but supplier identity for the brand is still NDC-specific.

5. What documents support supplier qualification for sterile ophthalmic solutions?
   GMP site documentation, aseptic process validation summaries, batch release specs, stability summaries, and container closure integrity evidence aligned to the exact NDC.

References

1. U.S. Food and Drug Administration. Structured Product Labeling (SPL) for olopatadine ophthalmic solution products. FDA.
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (olopatadine RLD entries). FDA.