PROMETH VC W/ CODEINE Drug Patent Profile

When do Prometh Vc W/ Codeine patents expire, and when can generic versions of Prometh Vc W/ Codeine launch?

Prometh Vc W/ Codeine is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in PROMETH VC W/ CODEINE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for PROMETH VC W/ CODEINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	1
DailyMed Link:	PROMETH VC W/ CODEINE at DailyMed

US Patents and Regulatory Information for PROMETH VC W/ CODEINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	PROMETH VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088764-001	Oct 31, 1984		DISCN	No	No

Prometh VC With Codeine Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 11, 2026

Prometh VC with Codeine is a generic prescription oral solution combining promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate. Its commercial value is limited by generic competition, opioid prescribing restrictions, pediatric safety warnings, seasonal demand, and the absence of publicly reported product-level revenue. The product has no identifiable standalone exclusivity period comparable to an innovative branded drug.

What is Prometh VC with Codeine?

Prometh VC with Codeine is an oral cough and cold product containing:

Component	Concentration per 5 mL	Function
Promethazine hydrochloride	6.25 mg	Antihistamine and antiemetic
Phenylephrine hydrochloride	5 mg	Nasal decongestant
Codeine phosphate	10 mg	Opioid antitussive

The product is administered by prescription and is generally supplied as an oral solution. Its pharmacological profile combines an antihistamine, a sympathomimetic decongestant, and an opioid cough suppressant.[1]

Codeine-containing cough products are controlled substances. The formulation falls within the federal Schedule V framework for certain low-concentration codeine preparations, subject to applicable federal and state requirements.[2]

Who manufactures Prometh VC with Codeine?

Historical product labeling identifies Hi-Tech Pharmacal Co., Inc. as the manufacturer or distributor associated with Prometh VC with Codeine.[1] Hi-Tech was acquired by Akorn in 2014. Akorn later entered bankruptcy proceedings, creating uncertainty around continuity of historical product supply and commercial ownership.[3]

The product is best analyzed as part of the generic prescription cough-and-cold market rather than as a major standalone franchise. Public company filings do not disclose product-level revenue for Prometh VC with Codeine.

What is the FDA regulatory status of Prometh VC with Codeine?

Prometh VC with Codeine is an approved prescription drug product marketed under the abbreviated generic-drug framework. The relevant commercial pathway is an Abbreviated New Drug Application, or ANDA, rather than a new molecular entity approval.

The ANDA pathway generally requires the applicant to demonstrate pharmaceutical equivalence and bioequivalence to the reference product. It does not provide the applicant with a new chemical-entity exclusivity period. FDA labeling includes opioid warnings, pediatric restrictions, respiratory-depression warnings, and contraindications associated with promethazine and codeine.[1,4]

The regulatory profile is affected by several FDA actions:

• FDA contraindicates codeine use for treating pain or cough in children younger than 12.
• FDA recommends against codeine use in adolescents aged 12 to 18 who have obesity, obstructive sleep apnea, or severe lung disease.
• Promethazine-containing products are contraindicated in children younger than 2 because of the risk of fatal respiratory depression.
• Codeine metabolism varies according to CYP2D6 genotype, creating a risk of unexpectedly high morphine exposure in ultrarapid metabolizers.[4]

These restrictions reduce the addressable pediatric market and increase prescriber, pharmacy, and managed-care scrutiny.

What patents protect Prometh VC with Codeine?

Prometh VC with Codeine does not appear to have a material product-specific patent estate comparable to an innovative branded medicine. The formulation contains long-established active ingredients, and the commercial product is marketed through the generic-drug system.

Protection category	Commercial relevance
New chemical entity patent	None identified for the combination
Composition-of-matter patent	No current protection expected for the established ingredients
Formulation patent	No material product-specific patent identified
Method-of-use patent	No prominent Orange Book-listed use patent identified
Biologic exclusivity	Not applicable
Small-molecule regulatory exclusivity	No standalone exclusivity period identified

The Orange Book is the principal FDA source for patents and regulatory exclusivity associated with approved drug products.[5] For a legacy generic cough syrup, the key competitive issue is usually ANDA approval, manufacturing capacity, controlled-substance compliance, and wholesale distribution rather than patent exclusion.

When does Prometh VC with Codeine lose exclusivity?

The product has no meaningful future “loss of exclusivity” event because it is already a mature generic product. Any relevant market protection would have arisen from the reference product’s historical approval and patent position, not from a current branded exclusivity period attached to Prometh VC with Codeine.

No FDA pediatric exclusivity, orphan-drug exclusivity, or new chemical entity exclusivity is associated with the combination.

How many patents cover Prometh VC with Codeine?

No material number of active, product-specific Orange Book patents can be attributed to Prometh VC with Codeine on the available public record. The product’s exposure to patent litigation is therefore low relative to drugs protected by formulation, device, crystalline-form, or method-of-use patents.

This does not eliminate all intellectual-property risk. Manufacturers may hold confidential manufacturing know-how, supplier agreements, process controls, trademarks, packaging rights, or non-Orange-Book patents. Those rights generally do not create the same automatic delay to generic approval as an Orange Book-listed patent.

Are there Paragraph IV challenges involving Prometh VC with Codeine?

No prominent public Paragraph IV dispute involving Prometh VC with Codeine has been identified. Paragraph IV litigation is more common for higher-value branded products with active Orange Book patents. A mature generic cough syrup offers limited economic incentive for a challenger to fund extensive patent litigation.

The more relevant approval risks are:

1. Failure to demonstrate bioequivalence.
2. FDA concerns regarding product quality or stability.
3. Controlled-substance recordkeeping deficiencies.
4. Manufacturing-site inspection findings.
5. Shortages of codeine, promethazine, phenylephrine, or packaging components.
6. State restrictions on opioid cough products.

What formulations are protected by Prometh VC with Codeine?

The commercial formulation is an oral solution containing promethazine, phenylephrine, and codeine. Its formulation value is primarily operational rather than patent-driven.

Formulation characteristics

The manufacturer must control:

• Uniform distribution of the active ingredients.
• Chemical stability of codeine and promethazine.
• Palatability and viscosity.
• Microbial quality of the aqueous solution.
• Accurate dosing through the supplied measuring device.
• Child-resistant packaging and controlled-substance labeling.

The oral-solution format creates manufacturing and quality risks that differ from tablet products. Liquid products can experience dosage nonuniformity, preservative problems, container-closure interactions, and supply interruptions involving bottles, caps, or dosing devices.

No prominent formulation patent has been identified as a major barrier to competing versions.

How does Prometh VC with Codeine compare with competing products?

Prometh VC with Codeine competes with both combination cough products and single-ingredient medicines.

Product category	Competitive advantage	Competitive weakness
Promethazine/codeine combinations	Sedating antitussive effect and established prescribing familiarity	Opioid restrictions, abuse risk, pediatric limitations
Dextromethorphan products	Non-opioid positioning and broad retail availability	Different efficacy and tolerability profile
Benzonatate	Prescription non-opioid antitussive	Capsule dosage form and swallowing risks
Promethazine-only products	Antihistamine and antiemetic utility	No opioid antitussive component
Guaifenesin combinations	Expectorant positioning and lower regulatory burden	Less direct antitussive effect
Nonprescription phenylephrine products	Easier access and lower cost	Limited clinical value for some congestion indications

The product’s main differentiator is the inclusion of codeine. That same attribute creates the strongest commercial constraint because opioid-related prescribing and dispensing controls narrow utilization.

What market dynamics affect Prometh VC with Codeine?

Seasonal demand

Demand is likely concentrated in the fall and winter respiratory season. Seasonal volume creates inventory-management risk. Manufacturers and wholesalers must carry sufficient stock for peak demand without overbuilding inventory that may face slow movement outside the season.

Opioid controls

Codeine cough products face stricter controls than non-opioid cough medicines. Pharmacies may apply additional verification procedures, state-specific dispensing limits, and prescriber scrutiny. These controls increase transaction costs and can shift prescribing toward dextromethorphan, benzonatate, or other non-opioid products.

Pediatric restrictions

FDA warnings materially reduce use in children and adolescents. Promethazine’s contraindication in children younger than 2 and codeine restrictions in patients younger than 12 remove a significant portion of the traditional pediatric cough-and-cold market.[4]

Generic pricing

The product is exposed to price competition from other manufacturers of promethazine/codeine or closely related combinations. Generic pricing can decline rapidly when multiple suppliers are active. Conversely, limited supplier participation can produce temporary price increases during shortages.

Controlled-substance supply chain

Codeine procurement requires compliance with federal controlled-substance quotas, security procedures, inventory controls, and recordkeeping. These requirements can deter smaller manufacturers and reduce the number of dependable suppliers.

What is the financial trajectory of Prometh VC with Codeine?

Public financial data do not provide a standalone revenue, gross-margin, prescription-volume, or market-share series for Prometh VC with Codeine. The product’s financial trajectory must therefore be inferred from its market structure rather than measured through reported brand sales.

Financial factor	Expected effect
Generic competition	Downward pressure on price and margin
Seasonal respiratory demand	Volume concentration and working-capital swings
Opioid restrictions	Long-term demand limitation
Supply shortages	Potential short-term pricing power
Manufacturing complexity	Higher quality and compliance costs than simple tablets
Limited differentiation	Low ability to sustain premium pricing
Product-level disclosure	Insufficient public data for precise revenue modeling

Historical ownership is also relevant. Akorn reported its business in aggregate categories rather than identifying Prometh VC with Codeine revenue separately.[3] Following Akorn’s financial distress and bankruptcy, ownership, distribution, and supply continuity became more important commercial variables than patent exclusivity.

Revenue exposure for manufacturers

Prometh VC with Codeine is unlikely to represent a material standalone revenue driver for a diversified pharmaceutical company. Its economic value is more likely to arise from inclusion in a broader portfolio of generic oral liquids, prescription cough products, and controlled substances.

The product can contribute incremental revenue when:

• Competitors experience shortages.
• Wholesalers seek an alternate supplier.
• Seasonal demand rises.
• A manufacturer retains an approved product while other suppliers exit.

Its earnings profile is less attractive when multiple suppliers compete on price or when pharmacies substitute non-opioid products.

What generic launch risks exist?

A new entrant would face low patent risk but moderate execution risk.

Manufacturing and regulatory barriers

The primary barriers include:

• ANDA approval and bioequivalence requirements.
• FDA inspection readiness.
• Controlled-substance registration and quota compliance.
• Stability data for an aqueous oral solution.
• Reliable active pharmaceutical ingredient supply.
• Packaging and dosing-device qualification.
• State-level opioid prescribing and dispensing requirements.

The absence of a strong patent estate makes market entry legally more accessible. It does not guarantee commercial success. Generic oral liquids can be difficult to manufacture consistently, and a low-volume product may not justify dedicated production capacity.

Generic launch scenarios

Scenario	Market result
One or two reliable suppliers	Stable pricing with periodic shortage-driven increases
Several active ANDA suppliers	Rapid price erosion and lower margins
Incumbent withdrawal	Temporary supply gap and higher acquisition value for an approved product
Strong non-opioid substitution	Structural volume decline
Regulatory or quality recall	Short-term shortage and reputational damage

What patent litigation and settlement agreements affect the product?

No significant product-specific patent litigation or settlement agreement has been identified. The low litigation profile is consistent with a mature generic combination product that lacks a high-value Orange Book patent estate.

The more important legal exposure involves product liability, controlled-substance compliance, labeling, recalls, and state opioid laws. Those issues can affect commercial availability without creating patent-based market exclusivity.

What is the biosimilar risk for Prometh VC with Codeine?

Biosimilar risk is not applicable. Prometh VC with Codeine is a small-molecule drug, not a biologic. Competition occurs through ANDA-based generic products and therapeutic substitution, not through the biosimilar pathway.

Key Takeaways

• Prometh VC with Codeine is a mature generic oral solution containing promethazine, phenylephrine, and codeine.
• No material product-specific patent estate or future exclusivity event has been identified.
• Paragraph IV litigation and settlement risk appear limited.
• The primary commercial risks are generic price competition, opioid restrictions, pediatric safety warnings, manufacturing complexity, and supply-chain volatility.
• Public filings do not disclose product-level revenue or market share.
• Historical association with Hi-Tech Pharmacal and Akorn is relevant to supply continuity, but not sufficient to establish a current standalone financial trajectory.
• The product’s value is driven by approved-market access and manufacturing reliability rather than patent barriers.

FAQs About Prometh VC with Codeine

Is Prometh VC with Codeine still commercially available?

Availability can vary by manufacturer, wholesaler inventory, state requirements, and controlled-substance supply conditions. FDA labeling and commercial distribution records should be distinguished from actual pharmacy-level availability.

Is Prometh VC with Codeine a Schedule V drug?

The codeine concentration is consistent with federal Schedule V treatment for qualifying codeine preparations, although state scheduling and dispensing rules may differ.[2]

Can a generic manufacturer launch Prometh VC with Codeine without a patent license?

A manufacturer generally does not need a patent license if no enforceable blocking patent applies. It must still satisfy FDA ANDA requirements and all controlled-substance and manufacturing obligations.

Does Prometh VC with Codeine have an Orange Book patent?

No material product-specific Orange Book patent has been identified as a current commercial barrier for the combination.[5]

Is Prometh VC with Codeine subject to biosimilar competition?

No. It is a small-molecule generic product and competes through generic-drug approvals, not biosimilar applications.

References

1. U.S. National Library of Medicine. (n.d.). Promethazine VC with Codeine oral solution: Drug label. DailyMed.
2. U.S. Drug Enforcement Administration. (n.d.). Controlled substance schedules.
3. Akorn, Inc. (2022). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
4. U.S. Food and Drug Administration. (2017, April 20). FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.