Suppliers and packagers for betimol

betimol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439	NDA	Thea Pharma Inc.	82584-002-05	1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER	2022-11-15

Executive summary: BETIMOL (timolol maleate) is a topical ophthalmic product with supply dominated by branded-generic labeling and contract manufacturing for ophthalmic liquids/solutions. Without the specific BETIMOL presentation (strength and dosage form), manufacturer identity cannot be pinned to a single supplier set.

What suppliers make BETIMOL (timolol maleate) ophthalmic products?
Featured snippet answer: BETIMOL is manufactured and supplied through branded labeling and contract manufacturing arrangements for timolol maleate ophthalmic solutions. Supplier identification depends on the exact country market and the precise product presentation listed on the local label and regulatory registry.

Which entities are typically “suppliers” for ophthalmic timolol like BETIMOL?

For ophthalmic small-molecule generics and branded generics, “suppliers” usually break into four buckets:

• Marketing authorization holder (MAH)/brand owner: the legal entity that holds the product authorization and releases product under the brand.
• Contract manufacturer (finished dosage): the site producing the ophthalmic solution (sterile fill-finish, batch release).
• API supplier (timolol maleate): the supplier of timolol maleate active pharmaceutical ingredient.
• Packaging and secondary supply chain: primary packaging compatibility (ocular bottles, droppers, seals), plus distribution/logistics.

Why “BETIMOL suppliers” varies by presentation and market

Timolol maleate ophthalmics are sold in multiple strengths and packaging formats (single- vs multi-dose containers). Each presentation can have different:

• finished dosage plant
• batch release site
• MAH and labeler
• importer/distributor

What is the Orange Book status of BETIMOL (timolol maleate) and who lists it?
Featured snippet answer: Orange Book status is tied to the exact FDA product listing (drug, route, dosage form, strength). Without the exact U.S.-listed presentation, a definitive manufacturer and labeler cannot be stated.

What to check in the FDA Orange Book for supplier identification

The FDA Orange Book entry typically provides:

• Applicant/holder (labeler/MAH)
• Generic/manufacturer details by NDA/ANDA listing
• Patent and exclusivity entries (if present)

Which patents cover BETIMOL timolol maleate ophthalmic solutions, and who holds them?
Featured snippet answer: Patents for timolol ophthalmic solutions depend on the specific formulation, packaging, and method-of-use claims. Supplier-related manufacturing is not reliably deduced from patent ownership.

Patent estate usually relevant for timolol ophthalmics

For ophthalmic timolol products, IP estates often include:

• composition/formulation patents (preservatives, solubilizers)
• packaging/contact-compatibility patents
• method-of-use (glaucoma/ocular hypertension treatment)

How supplier changes map to patent filings

• Contract finished dosage manufacturers may be linked to the ANDA/DMF route used for supply.
• API suppliers may be linked via DMFs that feed ANDAs, but those do not always map 1:1 to the commercial “brand” labeler.

What generic entry risks exist for BETIMOL (timolol maleate) ophthalmic products?
Featured snippet answer: Generic entry risk is primarily driven by remaining exclusivity and listed patents for the exact FDA product listing, not by the brand name alone.

What triggers launch risk for timolol ophthalmics

• exclusivity or remaining patent term on listed patents
• whether the brand has an ANDA or NDA product listing with listed patents
• whether competitors have already launched authorized generics in the same strength and dosage form

Key takeaways

Last updated: May 28, 2026

• BETIMOL is a timolol maleate ophthalmic brand; “supplier” varies by exact presentation and market regulatory listing.
• To identify specific suppliers (MAH/labeler, finished dosage manufacturer, and API source), the precise product listing (strength, dosage form, country) must match the regulatory registry entry.
• Patent coverage and generic launch risk also depend on the exact FDA/territory listing for the same presentation, not the brand name alone.

FAQs

1. How can I identify the MAH/labeler for BETIMOL in a specific country market?
2. Do API DMFs for timolol maleate map cleanly to finished-dose suppliers of ophthalmic solutions?
3. What data fields in the FDA Orange Book are most reliable for tying BETIMOL to a specific applicant?
4. How do preservative systems in timolol formulations affect supplier qualification and batch release?
5. What litigation or Paragraph IV history most often impacts timolol ophthalmic launches?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA databases).