BRIMONIDINE TARTRATE; BRINZOLAMIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-25	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER	2013-05-06
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251	NDA	Alcon Laboratories, Inc.	0065-4147-27	1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER	2013-05-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Brimonidine Tartrate and Brinzolamide Suppliers: API and Finished Dosage Manufacturing Landscape

Executive summary: Brimonidine tartrate and brinzolamide are niche ophthalmic actives used mainly in glaucoma and ocular hypertension. Supplier risk is concentrated in (1) API quality and regulatory familiarity for ophthalmic drugs, (2) ability to support sterile ophthalmic formulation manufacturing, and (3) geographic concentration of licensed API producers. In practice, procurement typically splits across: ophthalmic API specialists, generic sterile ophthalmic formulation manufacturers, and distributors sourcing from Asian API and CDMO networks.

Who supplies brimonidine tartrate API for ophthalmic products?

Direct API procurement typically comes from: ophthalmic-focused API manufacturers and general-purpose chemical API producers that also support DMF filings (or at least DMF-accessible supply chains) for regulators and customers. For ophthalmic products, buyers usually require consistent salt form control (brimonidine tartrate) and documented impurity profiles aligned with pharmacopeial and regulatory expectations.

Common brimonidine tartrate supply channels

API manufacturer → customer’s DMF letter of access (LOA) where available, or direct CoA supply plus impurity specs
API manufacturer → European/US distributor with lot traceability, repack, and QA documentation support
API + formulation CDMO where the CDMO handles sterile manufacturing transfer and validation with the API supplier

What buyers usually screen in brimonidine tartrate sourcing

Tartrate salt consistency (polymorph and moisture controls for stable dissolving behavior in ophthalmic systems)
Impurity profile for aldehyde-related and halogenated byproducts typical for synthetic route variants (buyer-specific)
Ophthalmic-grade upstream QC aligned to sterile dosage manufacturing expectations
DMF availability or regulatory history supporting rapid dossier updates for customers

Who supplies brinzolamide API and what sourcing constraints matter?

Brinzolamide suppliers are usually positioned as:

Specialty sulfonamide API producers (route and impurity control know-how)
Generic API suppliers with the ability to support scale and batch-to-batch reproducibility
CDMOs that can provide combined API + sterile formulation services for cost and timeline control

Brinzolamide API is sensitive to

Sulfonamide impurity control during synthesis and purification
Particle and dissolution behavior affecting formulation viscosity and dosing uniformity in ophthalmic suspensions
Moisture and stability controls to avoid viscosity drift and suspension settling risks in final drug product

What finished dosage form suppliers exist for brimonidine tartrate and brinzolamide ophthalmics?

Finished suppliers are commonly split into:

US/EU sterile ophthalmic manufacturers producing drops (solutions and suspensions)
CDMOs supporting commercial-scale sterile fill-finish for ophthalmic drugs
Packagers supplying labeled presentations only (less common for high-integrity ophthalmic sterile workflows)

Typical finished product configurations

Brimonidine tartrate: generally formulated as ophthalmic solutions for topical ocular administration
Brinzolamide: commonly formulated as ophthalmic suspensions (site- and concentration-specific)

Which companies supply brimonidine tartrate and brinzolamide most often to generics and ophthalmic brands?

Procurement and litigation patterns in ophthalmics tend to concentrate supply from a small number of API producers and sterile fill-finish partners that support recurring filings and scale for generic entrants.

A reliable way to map “which companies” is:

Orange Book and FDA approvals for finished products (then work backward to known API vendors referenced through DMF or customer supply chains), and
DMF/letter-of-access networks for ophthalmic APIs.

However, this request asks for specific supplier names. Producing a correct, named supplier list requires verified, current evidence from FDA DMFs, customer listings, or supplier disclosures tied to the actual actives and dosage forms. With no source inputs, a named list would risk inaccuracy.

What patents protect brimonidine tartrate and brinzolamide suppliers’ ability to operate?

Supplier freedom to operate is shaped less by API patents at large and more by:

Formulation patents (preservatives, viscosity agents, particle-size control, suspension stabilization)
Method-of-use patents (indications, dosing regimens)
Combination product patents (for dual-therapy formulations such as brimonidine + brinzolamide)

Common IP chokepoints suppliers must avoid

Fixation on sterile ophthalmic formulation processes and fill-finish parameters
Excipients and stabilizer systems that are protected in later filings
Combination product claims that limit generic reformulation

When do brimonidine tartrate and brinzolamide lose exclusivity for generic entry?

For older ophthalmic actives, exclusivity typically follows:

patent expiry on the listed reference drug(s),
regulatory exclusivity (if any) attached to NDA/505(b)(2) approvals,
remaining patent term on formulation or method-of-use.

A supplier’s practical “entry” timing is tied to:

FDA approval route (ANDA with Paragraph IV for unexpired patents vs carve-outs),
whether patents listed in the Orange Book cover formulation and not just the API.

Named timelines and exact “lose exclusivity” dates require a specific reference product and Orange Book patent list for that product, which cannot be produced accurately without source-level FDA record inputs.

What is the Orange Book status of brimonidine tartrate and brinzolamide products?

Orange Book status is product-specific and changes with each NDA holder and listed patent set. The actives alone do not define Orange Book listings or patent expiry.

A correct status mapping requires:

the exact FDA reference drug(s),
NDA numbers,
and the listed Orange Book patents and their expiration dates.

Without that, any status statement would be incomplete.

What generic entry risks exist for brimonidine tartrate and brinzolamide ophthalmics?

Generic entry risks for suppliers typically include:

Formulation patent barriers (preservative system and suspension control)
Method-of-use claim coverage (dosing frequency, target IOP reductions, monotherapy vs adjunctive use)
Combination product IP if customers plan to supply fixed-dose combinations

Operationally, the risk shows up during ANDA defense:

infringement analysis against listed Orange Book claims
whether the generic route can “design around” protected excipient systems or process claims.

How do brimonidine tartrate and brinzolamide sourcing strategies differ between brands and generics?

Brands

Prefer long-term API supply contracts with validated impurity profiles
Use in-house or preferred CDMOs for sterile fill-finish stability control
Keep tighter control of salt form, particle size, and suspension stability parameters

Generics

Build supplier qualification faster, often using multiple API sources to reduce shortages
Validate bioequivalence against reference standards and adjust formulation controls
Use CDMOs and formulation development teams with sterile ophthalmic experience

How many suppliers can realistically support sterile ophthalmic manufacturing for these actives?

Reality in ophthalmics:

fewer suppliers handle both the API and sterile ophthalmic fill-finish for drops at scale
additional constraints come from cleanroom validation, bioburden controls, and ocular safety expectations
multi-source procurement is feasible for API, less feasible for integrated sterile fill-finish unless the CDMO supports it

A numeric count of suppliers requires verified market databases or FDA-validated facility lists mapped to these actives, which cannot be reliably produced here.

Key Takeaways

Brimonidine tartrate and brinzolamide sourcing is dominated by a small set of ophthalmic-capable API producers and sterile ophthalmic fill-finish networks.
Main procurement constraints are impurity control, salt form consistency (brimonidine tartrate), and suspension/particle stability (brinzolamide).
Supplier due diligence should prioritize regulatory readiness (DMF access or dossier compatibility), ophthalmic-grade QC, and demonstrable sterile fill-finish capability.
Named “which suppliers” and Orange Book exclusivity timelines are product- and reference-drug-specific; actives alone do not support a precise supplier and patent map.

FAQs

Are brimonidine tartrate and brinzolamide commonly available from multiple API sources?
Availability is typically broader at the API level than at sterile ophthalmic fill-finish level.
Do brimonidine tartrate and brinzolamide require DMF or LOA to qualify with branded customers?
Many qualified procurement paths rely on DMF-readiness and impurity-spec alignment, often via LOA where applicable.
Which is harder to formulate: brimonidine tartrate solution or brinzolamide suspension?
Brinzolamide suspension systems are usually more formulation-sensitive due to particle size and suspension stability requirements.
Can suppliers avoid patents by changing excipients or process steps?
Patent risk is usually concentrated in formulation and method-of-use claims, so design-around feasibility depends on the claim language and the specific formulation.
What is the fastest route for a new generic entry with these ophthalmic actives?
The fastest path is typically a route with clear Orange Book carve-outs and formulation/process alignment that avoids infringement of listed formulation and method-of-use claims.

References

No sources were provided in the prompt to support a factual supplier list, Orange Book status, or exclusivity dates for specific NDA products.

Suppliers and packagers for generic pharmaceutical drug: BRIMONIDINE TARTRATE; BRINZOLAMIDE