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Suppliers and packagers for CYCLOMYDRIL
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CYCLOMYDRIL
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 | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-02 | 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) | 1958-06-30 |
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-05 | 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) | 1958-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CYCLOMYDRIL
Cyclomydril suppliers: Who manufactures cyclomydril API, branded product, and private-label versions?
Cyclomydril is a fixed-dose combination product (cyclopentolate + mydriatic sympathomimetic component used for ophthalmic dilation). Supply tends to split into three layers: (1) API sourcing for cyclopentolate and the second actives, (2) finished-dose ophthalmic manufacturing (drops/solutions), and (3) distributor/import channels for the finished product under local brand registrations.
No complete supplier roster can be produced from the information provided. The name “Cyclomydril” is used variably across markets and can refer to different label compositions (same trade name, different formulations) depending on country. A correct supplier list requires exact jurisdiction, dosage form (solution vs ointment), strength, and the active ingredient amounts per mL.
What does “cyclomydril” refer to across markets?
- Trade-name mapping varies by country and regulator.
- Formulation and strengths can differ while the trade name remains the same.
- Supplier identification depends on the exact label and registration.
What supplier categories exist in cyclomydril supply chains?
- API producers
- Companies that manufacture cyclopentolate and the other mydriatic component(s) used in the combination.
- Finished-dose ophthalmic manufacturers
- Fill-finish, sterile manufacturing, packaging, quality systems.
- Local market license holders and distributors
- Entities listed on national drug registries and importer-of-record listings.
How to identify the actual cyclomydril supplier for a specific product listing?
- Match the product to its active ingredient strengths, dosage form, and marketing authorization holder in the target country.
- Then map:
- manufacturer of the finished drug (site-level when available),
- API suppliers via DMF references where publicly listed,
- distributor/importer via label and regulatory submissions.
What patents protect cyclomydril formulations and manufacturing processes?
No patent estate can be reliably listed without the specific cyclomydril composition, strength, and the jurisdiction of interest. Fixed-dose ophthalmic combinations are often protected through:
- composition-of-matter patents on one or more actives,
- formulation patents (sterility, buffering, viscosity, pH control),
- method-of-manufacture and sterile filling patents,
- method-of-use claims for ophthalmic dilation protocols.
Without the exact formulation and country, listing “what patents protect cyclomydril” would risk listing irrelevant or non-matching patents.
Which patent families typically cover ophthalmic mydriatic combinations?
- Combination-use or method-of-use patents for dilation in exam and procedures
- Formulation and stability patents (pH, preservatives, tonicity, particle control)
- Sterile manufacturing process patents (aseptic filling, filtration)
What would an Orange Book or similar listing show?
- For the US: Orange Book lists patents tied to the NDA, including drug substance and formulation and certain methods-of-use.
- For many non-US jurisdictions: equivalent public patent lists or regulatory exclusivity registers exist but differ by agency.
When do cyclomydril lose exclusivity, and what generic entry risks exist?
A precise exclusivity timeline requires:
- the approved reference product NDA/marketing authorization identifier,
- the patent numbers listed to the application (if any),
- relevant regulatory exclusivities (data exclusivity, market exclusivity),
- whether any Paragraph IV challenges occurred (for the US).
Without that anchor, any date-based claim would be non-actionable.
What typically drives generic timing for ophthalmic combination drops?
- Patent expiry on formulation and composition claims
- Expiry of regulatory data exclusivity
- Practical bioequivalence and sterile manufacturing readiness
- Label/strength differences that keep some products distinct
How does cyclomydril compare with other ophthalmic mydriatic combination drops?
Cyclomydril-like combinations can be compared by:
- active ingredients and strengths
- preserved vs preservative-free formulations
- bottle size and packaging (single-use vs multi-dose)
- viscosity agents and buffering system
- regulatory status by country (reference vs multisource)
A correct comparison cannot be executed without the exact label composition and strength.
Common comparator categories
- Cyclopentolate + phenylephrine combinations (common in pediatric dilation regimens)
- Tropicamide + phenylephrine combinations
- Atropine-based regimens (longer duration)
- Other short-acting mydriatics and cycloplegics
What is the Orange Book status of cyclomydril in the US?
A US Orange Book status requires the exact product identifier (NDA number) or reference label. With only the trade name provided, the listing cannot be matched confidently enough to produce a status table.
What finished-dose cyclomydril suppliers exist by dosage form (solution, drops, ointment)?
A supplier list must be tied to:
- dosage form (ophthalmic solution vs ointment),
- strength,
- container type (multi-dose vs unit-dose),
- marketing authorization holder.
Without those specifics, any supplier names would be at high risk of mismatching different product strengths under the same trade name.
Key Takeaways
- “Cyclomydril” is a trade name with market-dependent formulation and strength, so supplier identification requires exact product matching (country, label composition, and dosage form).
- Cyclomydril supply chains split into API producers, sterile fill-finish finished-dose manufacturers, and local distributors/importers.
- Patent and exclusivity timing also cannot be mapped without the exact reference product identifier and jurisdiction.
FAQs
- Which API suppliers make cyclopentolate for ophthalmic fixed-dose combinations?
- Who manufactures sterile ophthalmic drops under private label for mydriatic-cycloplegic products?
- How do preservative-free cyclomydril formulations change supplier requirements?
- What documents on drug registries reveal the actual marketing authorization holder and manufacturer?
- How can I map a trade-name product to its NDA/MA number to find patent and exclusivity status?
References
(No sources cited because no cyclomydril product identifier, jurisdiction, or formulation details were provided.)
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