CHLOROMYCETIN HYDROCORTISONE Drug Patent Profile

When do Chloromycetin Hydrocortisone patents expire, and when can generic versions of Chloromycetin Hydrocortisone launch?

Chloromycetin Hydrocortisone is a drug marketed by Parkedale and is included in one NDA.

The generic ingredient in CHLOROMYCETIN HYDROCORTISONE is chloramphenicol; hydrocortisone acetate. There are fourteen drug master file entries for this compound. Additional details are available on the chloramphenicol; hydrocortisone acetate profile page.

Summary for CHLOROMYCETIN HYDROCORTISONE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CHLOROMYCETIN HYDROCORTISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parkedale	CHLOROMYCETIN HYDROCORTISONE	chloramphenicol; hydrocortisone acetate	FOR SUSPENSION;OPHTHALMIC	050202-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Chloromycetin Hydrocortisone: Investment Scenario and Fundamentals Analysis (Patent, Exclusivity, and Competitive Risk)

Last updated: July 11, 2026

Executive summary: Chloromycetin Hydrocortisone is a branded, fixed-dose topical combination of chloramphenicol (antibiotic) and hydrocortisone (corticosteroid). Investment fundamentals are constrained by (1) high historical generic penetration in topical chloramphenicol markets, (2) routine substitution dynamics driven by local manufacturing capacity and prescriber familiarity, and (3) limited evidence of ongoing, enforceable blockbuster-style exclusivity in major jurisdictions. For an investor, the payoff profile is typically “small molecule off-label/topical niche” rather than a long-duration patent moat. The core underwriting is whether any still-active rights exist in specific geographies for the combination product (not just each API) and whether there is active regulatory/market protection via data exclusivity or formulation/method-of-use patents.

No complete, accurate, citation-backed patent, Orange Book, FDA, or litigation mapping can be produced for this specific drug name based on the information available in this session.

What is Chloromycetin Hydrocortisone and what market role does it play?

Short answer: It is a topical combination product using chloramphenicol + hydrocortisone aimed at localized skin/eye-ear inflammatory-infectious conditions where bacterial coverage and corticosteroid anti-inflammatory effect are both used.

Which therapeutic category does it sit in?

• Anti-infective + corticosteroid topical combination
• Typical use cases in practice vary by country and labeled indications, often grouped into:
  • infected dermatitis/dermatoses with suspected bacterial involvement
  • otic/ocular inflammatory infectious conditions, depending on licensed presentation

Which dosage forms matter for investment?

• Ointment and/or cream are common for topical “antibiotic-steroid” combos
• Eye/ear drops and suspensions may exist as separate branded SKUs in some markets
• Commercial risk differs by dosage form due to formulation IP and local regulatory pathways

What patents protect Chloromycetin Hydrocortisone (combination product vs. APIs)?

Short answer: Combination products can be protected by patents tied to the specific formulation, fixed ratio, manufacturing method, and stability. However, investment relevance depends on whether those patents are still within term in target jurisdictions.

How to think about enforceability for combination topical antibiotics + steroids

Patent estates in this category usually split across:

• Composition of matter (combination/formulation): fixed-dose ratio, excipients, particle/crystal properties, preservative/stabilizer systems
• Manufacturing/process: mixing order, sterilization/aseptic processing, container-closure system compliance
• Method of treatment: sometimes used for dosing schedules or indication-specific regimens
• New use: less common where topical antibiotics and steroids have long clinical history

API-level patents are rarely the whole story

• Chloramphenicol is long out of patent in major markets.
• Hydrocortisone is also long out of patent in most jurisdictions.
• The investment question is whether the combination product still has active, enforceable rights on:
  • fixed ratio formulation
  • stability and shelf-life in the marketed container
  • specific delivery form (e.g., ophthalmic suspension vs ointment)

When does exclusivity end for Chloromycetin Hydrocortisone?

Short answer: For mature topical antibiotic-steroid products, exclusivity typically has already expired in most markets with generic availability. Any remaining protection would likely be limited to late-life patents on formulation/manufacturing in specific countries or ongoing regulatory data exclusivity tied to a local reference product.

How exclusivity usually works for this drug class

• If launched decades ago: patents and data exclusivity likely expired
• If a modern reformulation exists: a newer local filing could create shorter-lived exclusivity windows
• If the product is a non-FDA reference product in the US: exclusivity analysis requires the local regulator’s exclusivity framework, not only FDA constructs

What is the Orange Book status of Chloromycetin Hydrocortisone in the U.S.?

Short answer: A definitive Orange Book status cannot be provided in this session because the necessary Orange Book listing evidence for this exact product name is not present.

What to check for investors (Orange Book fields that drive risk)

• Listed drug (RLD) identity
• Patent numbers and expiration dates
• Patent types (drug substance, drug product, method of use)
• Whether patents are “Orange Book listed” for the combination product specifically

What patent expiration dates matter most for Chloromycetin Hydrocortisone?

Short answer: In practice, the expiration dates that matter are those tied to the combination product (drug product/formulation, not just the underlying APIs) and those that cover the specific dosage form and route of administration (dermatologic vs ophthalmic/otic).

Expiration timing that drives generic entry models

• If there are active formulation/process patents: generic entry may be delayed until expiry or design-around
• If only API/public domain coverage exists: entry barriers are mainly regulatory and manufacturing quality, not IP

Which companies market or supply Chloromycetin Hydrocortisone, and how does the competitive landscape look?

Short answer: Competitive pressure is typically dominated by:

• generic/local brand manufacturers
• multinationals only when the product has enough volume to justify regional licensing

What competition signals to model

• Number of SKUs by dosage form and strength
• Price compression and tender dynamics in institutional sales
• Availability of multiple generics indicates low IP barriers

What generic entry risks exist for Chloromycetin Hydrocortisone?

Short answer: Generic entry risk is generally high for mature topical antibiotic-steroid products, unless local formulation/presentation patents still protect the exact marketed product.

Generic scenarios investors underwrite

• Straight generic approval against an RLD where no relevant patents are listed or already expired
• Patent litigation or settlement-driven “at-risk” entry timing (if any active patents remain)
• Substitution risk: prescribers may switch to other antibiotic-steroid combos (different APIs) even if the exact brand is protected

What patent litigation affects Chloromycetin Hydrocortisone?

Short answer: No litigation record can be mapped here without access to case dockets or a sourced litigation dataset for the exact brand.

How litigation typically affects products in this category

• Paragraph IV challenges are most relevant when there are Orange Book listed patents.
• For topical combinations, litigation is less frequent than for high-cost systemics, unless a specific combination/formulation was recently patented.

What settlement agreements or licensing deals exist for Chloromycetin Hydrocortisone?

Short answer: No deal information can be provided in this session without sourced references tied to the specific product brand and jurisdictions.

What licensing terms usually look like if present

• Geographic scope carve-outs
• Authorized generic or distribution agreements
• “No-challenge” clauses linked to dismissal timing

What formulations are protected by Chloromycetin Hydrocortisone patents?

Short answer: Potentially protected elements include the fixed-dose ratio, excipient selection, preservative/stabilizer system, and delivery characteristics tied to the product’s final dosage form. Without specific patent data, the exact protected formulation set cannot be stated.

Formulation risk drivers

• Whether competitors can use the same ratio but different excipients
• Whether container-closure compatibility impacts stability and is patent-covered
• Whether ophthalmic/otic versions use different stability or sterilization methods that change the IP landscape

How does Chloromycetin Hydrocortisone compare with alternative antibiotic-steroid topicals?

Short answer: The main competitive substitutes are other topical antibiotic-steroid combinations and single-agent anti-inflammatory therapies combined with separate antimicrobials. Substitution pressure is driven by safety perceptions, local availability, and labeled indication alignment.

What matters in substitution

• Spectrum of antimicrobial coverage and resistance patterns
• Corticosteroid potency and tolerability
• Safety constraints around chloramphenicol in certain regions (regulatory stance varies)

What does the FDA regulatory status imply for investment in Chloromycetin Hydrocortisone?

Short answer: A definitive FDA status cannot be provided here because no FDA reference/labeling or pathway data is available in this session.

For investors, the key regulatory questions are:

• Is the product approved and marketed in the U.S. as a specific NDA/ANDA listed drug?
• Is it an RLD for generics?
• Are there pediatric exclusivities or data exclusivities that still matter (rare for this class, but jurisdiction dependent)?

Can a biosimilar risk analysis apply?

Short answer: Biosimilar risk is not applicable because chloramphenicol/hydrocortisone is not a biologic.

Commercial fundamentals: what determines unit economics and revenue durability?

Short answer: Revenue durability is driven by:

• sustained indication relevance in local prescribing practices
• price elasticity from generic availability
• supply continuity and regulatory compliance of contract manufacturers

What to underwrite in financial modeling

• Volume stability: topical products often track chronic or episodic care trends
• Gross margin: erodes with generic price competition
• Marketing spend: often modest relative to systemics, but depends on tender systems
• Shelf-life and formulation stability: affects supply reliability and returns

Investment thesis check: where does value concentrate?

Short answer: Value concentrates only if there is a still-active moat around the exact combination product, specific dosage form, and specific country labeling. Otherwise the product behaves like a commoditizing topical.

Most likely “investment-ready” profiles in this category

• A still-protected, recently reformulated combination with strong distribution in a defined geography
• A product with limited generic penetration due to manufacturing constraints or regulatory friction
• A specialized ophthalmic/otic presentation where stability and manufacturing controls limit simple substitution

Most likely “low-moat” profiles

• Long-standing market with multiple generics
• No Orange Book-relevant patents or patents already expired
• High substitutability to other antibiotic-steroid combos or separate anti-inflammatory + antibiotic approaches

Key Takeaways

• Chloromycetin Hydrocortisone is a mature topical antibiotic-steroid combination where API patents are not the basis for defensible exclusivity.
• Investment upside depends on whether combination/formulation or process IP still has enforceable life in targeted jurisdictions, plus whether regulatory and pricing dynamics sustain premium branding.
• Without sourced Orange Book/FDA patent listing and jurisdiction-specific patent data for this exact product brand, a precise exclusivity and litigation risk assessment cannot be stated.

FAQs

1. Is Chloromycetin Hydrocortisone available as a generic in most countries?
2. Do patents for chloramphenicol and hydrocortisone individually still matter for this combination product?
3. What are the main risks of market share loss for topical antibiotic-steroid brands?
4. How do formulation differences (cream vs ointment vs ophthalmic/otic forms) change the IP landscape?
5. Does FDA exclusivity meaningfully protect this drug category in the U.S.?

References

None cited in this session.