PHENERGAN VC W/ CODEINE Drug Patent Profile
Which patents cover Phenergan Vc W/ Codeine, and what generic alternatives are available?
Phenergan Vc W/ Codeine is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in PHENERGAN 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.
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Questions you can ask:
- What is the 5 year forecast for PHENERGAN VC W/ CODEINE?
- What are the global sales for PHENERGAN VC W/ CODEINE?
- What is Average Wholesale Price for PHENERGAN VC W/ CODEINE?
Summary for PHENERGAN VC W/ CODEINE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 1 |
| DailyMed Link: | PHENERGAN VC W/ CODEINE at DailyMed |
US Patents and Regulatory Information for PHENERGAN 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | PHENERGAN VC W/ CODEINE | codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride | SYRUP;ORAL | 008306-005 | Apr 2, 1984 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
PHENERGAN VC WITH CODEINE Market Dynamics, Patent Status, and Financial Trajectory
Phenergan VC with Codeine is a prescription oral cough-and-cold product containing promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate. Its commercial outlook is structurally weak. The product is an older combination medicine with no meaningful new-drug exclusivity, limited differentiation, substantial pediatric and opioid-related restrictions, and competition from generic ingredients and non-opioid alternatives. No standalone revenue is publicly reported for Phenergan VC with Codeine, so its financial trajectory must be assessed through product availability, regulatory constraints, category demand, and the economics of mature prescription cough medicines.
What is Phenergan VC with Codeine?
Phenergan VC with Codeine combines three active ingredients:
| Component | Function | Commercial role |
|---|---|---|
| Promethazine hydrochloride | Antihistamine and antiemetic | Reduces allergy-related symptoms and nausea |
| Phenylephrine hydrochloride | Nasal decongestant | Reduces nasal congestion |
| Codeine phosphate | Opioid antitussive | Suppresses cough |
The product is an oral prescription syrup historically marketed under the Phenergan brand. It is distinct from Phenergan with Codeine, which contains promethazine and codeine but does not contain phenylephrine.
The product’s principal commercial exposure is in short-duration treatment of cough and upper-respiratory symptoms. It is not a chronic-use medicine and has limited ability to generate recurring prescription volume.
What is the FDA regulatory status of Phenergan VC with Codeine?
Phenergan VC with Codeine is an FDA-regulated prescription drug product associated with the Phenergan franchise and an older New Drug Application. Its regulatory profile is affected by several FDA actions covering codeine-containing cough medicines and pediatric use.
In 2018, the FDA required labeling changes for prescription cough and cold medicines containing codeine or hydrocodone. The agency restricted use in children younger than 18 because of the risk of misuse, addiction, respiratory depression, overdose, and death. The FDA had already prohibited codeine use in children younger than 12 and warned against use in certain adolescents after tonsillectomy or adenoidectomy.[1][2]
The current commercial implications are significant:
- Pediatric prescribing is sharply constrained.
- Providers have less incentive to prescribe opioid cough products.
- Pharmacies face controlled-substance handling and diversion concerns.
- Parents and health systems increasingly prefer non-opioid treatments.
- Prescribers may avoid the product even when the label permits adult use.
FDA labeling also warns about respiratory depression, sedation, impaired driving, drug interactions, and the risks of combining codeine with alcohol, benzodiazepines, or other central nervous system depressants.[3]
What is the Orange Book status of Phenergan VC with Codeine?
The product does not have the commercial profile of a recently approved branded medicine with active Orange Book patent protection. The relevant intellectual-property estate is principally historical rather than exclusionary.
The FDA Orange Book generally lists patents and regulatory exclusivity for approved products when applicable. For an old promethazine, phenylephrine, and codeine combination, the original active-ingredient and product patents would have expired long ago. No commercially significant current patent barrier is apparent from the product’s age, generic availability of the individual ingredients, and lack of recent formulation innovation.[4]
| Exclusivity category | Assessment |
|---|---|
| New chemical entity exclusivity | Expired |
| Orphan-drug exclusivity | Not applicable |
| Pediatric exclusivity | Not a current commercial barrier |
| New formulation exclusivity | No material current protection identified |
| Method-of-use exclusivity | No material current protection identified |
| Orange Book patent barrier | No meaningful barrier identified |
| Biosimilar exclusivity | Not applicable |
When does Phenergan VC with Codeine lose exclusivity?
Phenergan VC with Codeine lost meaningful regulatory exclusivity decades ago. Exact original patent expiration dates are not commercially determinative because the active ingredients are long-established and the product competes in a mature generic market.
The principal legal conclusion is that generic or therapeutically substitutable competition does not need to overcome a modern patent estate. Any remaining commercial rights are more likely to involve trademarks, product branding, manufacturing know-how, distribution arrangements, or state-specific regulatory requirements than active compound patents.
How many patents cover Phenergan VC with Codeine?
No meaningful active patent estate is apparent for the product’s three-ingredient combination. The relevant patent count is therefore effectively zero for current market-exclusion purposes.
This conclusion should be separated from historical patent activity. Patents may have covered earlier formulations, manufacturing processes, packaging, or specific dosage configurations. Expired patents do not prevent generic entry and do not support a current branded price premium.
The strongest residual IP rights are likely to be:
- The Phenergan trademark and related brand assets.
- Proprietary manufacturing specifications, if any remain in use.
- Distribution and supply-chain arrangements.
- Trade dress or labeling rights, subject to generic substitution rules.
What formulations are protected by Phenergan VC with Codeine patents?
No current commercially material formulation protection is apparent. The product is a conventional oral syrup rather than a technically differentiated delivery system.
It does not have the principal characteristics that support a modern formulation patent strategy:
- Extended-release delivery.
- A novel abuse-deterrent platform.
- A long-acting injectable form.
- A proprietary device.
- A new salt, polymorph, or complex.
- A clinically differentiated fixed-dose formulation.
The syrup format creates practical manufacturing and quality-control requirements, including content uniformity, preservative performance, viscosity, microbial control, and opioid inventory controls. Those requirements can create operational friction without creating durable market exclusivity.
Are there Paragraph IV challenges to Phenergan VC with Codeine?
No prominent current Paragraph IV litigation is associated with Phenergan VC with Codeine in the publicly visible commercial record. That result is consistent with the product’s age and limited branded value.
Paragraph IV litigation is more economically attractive when a branded product has:
- High annual sales.
- A strong patent barrier.
- Limited therapeutic substitution.
- A near-term generic launch opportunity.
- Significant remaining patent life.
Phenergan VC with Codeine does not appear to meet those conditions. A generic manufacturer would more likely rely on ordinary abbreviated approval and commercial substitution than pursue expensive litigation against a legacy combination product.
What patent litigation affects Phenergan VC with Codeine?
No material current patent litigation is identified in the cited FDA and public-company materials. The principal legal risks are regulatory and commercial rather than patent-based.
Relevant legal exposure includes:
- Product-liability claims involving respiratory depression or overdose.
- Failure-to-warn allegations.
- Controlled-substance compliance.
- Manufacturing and quality violations.
- Pediatric prescribing and promotion restrictions.
- Trademark or unfair-competition disputes involving the Phenergan name.
The product’s opioid component increases litigation sensitivity even if no patent dispute is active.
Which companies are challenging Phenergan VC with Codeine?
Competition is likely to come from manufacturers of generic promethazine-codeine products, generic promethazine, phenylephrine-containing products, non-opioid cough suppressants, antihistamines, and decongestants. The relevant competitive set includes manufacturers operating through abbreviated new drug applications and contract manufacturing channels.
The market is fragmented. No single generic challenger needs to displace the entire brand. Pharmacies and wholesalers can source equivalent or near-equivalent products based on price, supply reliability, controlled-substance compliance, and wholesaler availability.
The product also competes with:
- Dextromethorphan-based cough products.
- Benzonatate.
- Guaifenesin combinations.
- Intranasal corticosteroids.
- Oral antihistamines.
- Saline and topical decongestant products.
- Supportive care without prescription medication.
What is the financial trajectory of Phenergan VC with Codeine?
No standalone revenue, profit, prescription, or market-share figures are disclosed by Pfizer or other public companies for Phenergan VC with Codeine. Pfizer reports revenue at broader product and business-segment levels and does not separately identify the product in its annual financial disclosures.[5]
The likely financial trajectory is:
| Period | Commercial condition | Financial implication |
|---|---|---|
| Historical branded period | Brand recognition and prescription use | Higher pricing potential |
| Generic competition period | Ingredient and therapeutic substitution | Lower price and share |
| Post-2017 safety restrictions | Reduced pediatric and opioid prescribing | Lower addressable volume |
| Mature-market period | Limited differentiation and supply variability | Low strategic priority |
| Current outlook | Legacy brand economics | Limited revenue growth potential |
The product’s revenue base is likely small relative to major pharmaceutical assets. A legacy cough syrup can remain profitable if manufacturing costs are low and distribution is stable, but its growth ceiling is limited. Price increases may produce short-term revenue gains but also raise substitution, payer, and regulatory scrutiny.
What market dynamics affect Phenergan VC with Codeine?
The largest demand-side factor is the decline in opioid cough prescribing. The FDA’s pediatric restrictions and broader opioid stewardship policies have reduced the addressable population.[1][2]
Supply-side economics are also challenging:
- Codeine requires controlled-substance controls.
- Syrup manufacturing has higher quality-control requirements than simple tablets.
- Shortages can disrupt pharmacy availability.
- Low-volume products may be deprioritized by manufacturers.
- Wholesalers may favor products with higher turnover.
- Brand pricing is constrained by generic substitution.
The product may retain niche demand among adult patients who respond to or prefer prescription cough suppression. That niche is too narrow to support a strong growth profile without a new indication, new delivery technology, or substantial commercial repositioning.
Does Phenergan VC with Codeine face biosimilar risk?
No. Biosimilar competition applies to biological products, not conventional small-molecule combinations such as promethazine, phenylephrine, and codeine.
The relevant competitive threat is generic substitution. Generic manufacturers can compete through abbreviated regulatory pathways, subject to demonstrating pharmaceutical equivalence and meeting FDA quality requirements.
Are there licensing deals for Phenergan VC with Codeine?
No material recent licensing transaction specifically involving Phenergan VC with Codeine is identified in the cited public sources. The product is associated with an older branded franchise rather than a current licensing platform.
A transaction involving the product would most likely be structured as:
- A mature-brand acquisition.
- A regional commercialization agreement.
- A product-line divestiture.
- A supply and distribution agreement.
- A contract manufacturing arrangement.
The strategic value would depend more on manufacturing economics, brand recognition, and distribution rights than on patent protection.
What generic launch scenarios exist for Phenergan VC with Codeine?
Three commercial scenarios are most relevant.
Continued legacy availability
The brand or an authorized distributor maintains limited availability for adult prescriptions. Revenue remains low but positive, supported by brand familiarity and residual prescriber demand.
Generic substitution
Generic promethazine-codeine and related cough products capture most price-sensitive demand. The branded product becomes a niche option, with declining volume and limited pricing power.
Commercial withdrawal
The manufacturer or distributor exits because controlled-substance compliance, low volume, manufacturing cost, or supply complexity makes the product uneconomic. Demand migrates to generic products and non-opioid alternatives.
The third scenario is credible for mature combination products, but public records should be used to distinguish true discontinuation from temporary supply disruption or a change in labeler.
How strong is the patent estate for Phenergan VC with Codeine?
The patent estate is weak from a current commercial perspective. Its main strengths are historical brand recognition and possible manufacturing know-how. Its principal weaknesses are the absence of meaningful exclusivity, mature active ingredients, generic competition, opioid-related restrictions, and limited clinical differentiation.
| Factor | Assessment |
|---|---|
| Compound protection | Very weak |
| Formulation protection | Weak |
| Method-of-use protection | Weak |
| Trademark value | Moderate but declining |
| Regulatory exclusivity | Expired |
| Generic entry risk | High |
| Litigation deterrence | Low |
| Revenue growth potential | Low |
What is the geographic coverage of Phenergan VC with Codeine?
The product’s most relevant regulatory and commercial market is the United States. FDA approval, U.S. controlled-substance rules, Orange Book treatment, and U.S. pharmacy substitution practices determine the principal market dynamics.
International rights should not be inferred from U.S. approval. Promethazine, phenylephrine, and codeine products are regulated differently across jurisdictions. Codeine restrictions, prescription status, pediatric labeling, and availability vary by country. A U.S. product label does not establish foreign marketing authorization or patent protection.
Key Takeaways
- Phenergan VC with Codeine is a mature prescription syrup containing promethazine, phenylephrine, and codeine.
- Its meaningful regulatory exclusivity and any original compound protection expired long ago.
- No commercially significant current patent estate or active Paragraph IV dispute is apparent.
- FDA restrictions on pediatric codeine use materially reduce the addressable market.
- Generic and non-opioid alternatives create high substitution risk.
- Pfizer does not separately disclose product revenue, so standalone financial performance cannot be quantified from public company filings.
- The likely financial trajectory is declining or low-level legacy revenue rather than growth.
- The main risks are regulatory, product-liability, supply-chain, and commercial, not patent litigation.
- Biosimilar risk is irrelevant; generic substitution is the central competitive threat.
- The most plausible outcomes are continued niche availability, generic displacement, or commercial withdrawal.
FAQs
Is Phenergan VC with Codeine still available by prescription?
Availability can vary by labeler, pharmacy inventory, wholesaler supply, and market period. It remains a prescription opioid-containing cough product subject to FDA labeling and controlled-substance requirements.
Is Phenergan VC with Codeine the same as promethazine-codeine syrup?
No. Phenergan VC with Codeine contains promethazine, phenylephrine, and codeine. Promethazine-codeine syrup contains promethazine and codeine without phenylephrine.
Can a generic company launch Phenergan VC with Codeine without patent litigation?
Generally, an old combination product with no blocking patent protection can be challenged through the applicable abbreviated approval pathway without a commercially meaningful patent settlement.
Why has demand for codeine cough syrup declined?
FDA pediatric restrictions, opioid stewardship, overdose concerns, controlled-substance compliance, prescriber caution, and availability of non-opioid treatments have reduced demand.
Does Phenergan VC with Codeine have value in a pharmaceutical acquisition?
Its value would likely come from residual brand demand, distribution, manufacturing rights, or portfolio fit. Patent-based valuation would be limited because the product lacks meaningful current exclusivity.
References
- U.S. Food and Drug Administration. (2018). FDA requires labeling changes regarding use of prescription opioid cough and cold medicines in children and adolescents.
- U.S. Food and Drug Administration. (2017). FDA drug safety communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
- U.S. Food and Drug Administration. (n.d.). Phenergan VC with Codeine prescribing information.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th ed.
- Pfizer Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
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