PHENERGAN W/ CODEINE Drug Patent Profile

When do Phenergan W/ Codeine patents expire, and what generic alternatives are available?

Phenergan W/ Codeine is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in PHENERGAN W/ CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.

Summary for PHENERGAN W/ CODEINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	227
DailyMed Link:	PHENERGAN W/ CODEINE at DailyMed

US Patents and Regulatory Information for PHENERGAN 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 W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	008306-004	Apr 2, 1984		DISCN	Yes	No

PHENERGAN WITH CODEINE Market Dynamics, Patent Status, FDA Regulation, and Financial Trajectory

Last updated: August 1, 2026

Phenergan with Codeine is a mature prescription cough-and-cold product containing promethazine hydrochloride and codeine phosphate. Its commercial value has declined because the product has no meaningful remaining market exclusivity, faces widespread generic substitution, and is subject to opioid restrictions that have reduced prescribing and distribution. Pfizer’s ownership of the legacy Wyeth brand does not create a material modern patent barrier. Public financial filings do not separately report Phenergan with Codeine revenue, so product-level sales cannot be reliably isolated from Pfizer’s broader established-products portfolio.

What is Phenergan with Codeine?

Phenergan with Codeine is an oral solution combining an antihistamine and phenothiazine derivative, promethazine, with the opioid antitussive codeine.

Product attribute	Details
Brand	Phenergan with Codeine
Active ingredients	Promethazine hydrochloride and codeine phosphate
Dosage form	Oral solution
Common labeled strength	Promethazine 6.25 mg and codeine 10 mg per 5 mL
Therapeutic category	Prescription cough and upper-respiratory symptom treatment
Original sponsor lineage	Wyeth Laboratories and later Wyeth Pharmaceuticals
Current corporate owner of Wyeth assets	Pfizer
FDA application	NDA 008306
Controlled-substance status	Federally Schedule V when formulated within applicable codeine concentration limits
Prescription status	Prescription-only
Primary commercial substitutes	Generic promethazine-codeine oral solutions and non-opioid cough products

The product is distinct from promethazine-only products, which are marketed for allergy, nausea and vomiting, and other indications. Codeine creates the principal regulatory, abuse, diversion, and payer-management risk.

What is the FDA status of Phenergan with Codeine?

FDA-approved labeling identifies Phenergan with Codeine as a prescription oral solution. The product is subject to opioid-specific labeling requirements, including warnings concerning respiratory depression, misuse, abuse, addiction, overdose, accidental ingestion, and neonatal opioid withdrawal syndrome.[1]

The FDA required manufacturers of prescription opioid cough-and-cold medicines containing codeine or hydrocodone to revise labeling in 2018. The revised labeling removed pediatric use below age 18 and required that these products be labeled for adults 18 and older because the risks outweighed the benefits in children.[2]

The product’s commercial status should be assessed separately from its regulatory approval. An FDA-approved NDA can remain in the agency’s database even when a particular branded presentation is no longer actively marketed or has limited distribution. FDA’s Drugs@FDA and Orange Book records are the controlling sources for current application and marketing-status determinations.[3]

What is the Orange Book status of Phenergan with Codeine?

Phenergan with Codeine has no commercially relevant remaining new-drug exclusivity. Its original approval dates to the early era of U.S. drug regulation, and any original composition, formulation, or use protections would have expired decades ago.

The product does not have a modern patent estate comparable to a recently approved specialty drug. The commercial market is therefore governed by:

• Generic competition under abbreviated new drug applications.
• State and federal opioid controls.
• Distribution and pharmacy policies.
• Prescriber demand for opioid cough products.
• Availability of non-opioid alternatives.

The Orange Book remains relevant for identifying the NDA and any listed patents or exclusivity entries. It does not create a current barrier to generic promethazine-codeine competition in the absence of unexpired listed patents or exclusivity.[3]

When did Phenergan with Codeine lose exclusivity?

Phenergan with Codeine lost practical market exclusivity long before the modern Hatch-Waxman framework matured. The product’s original approval predates current five-year new chemical entity exclusivity, three-year clinical-investigation exclusivity, pediatric exclusivity, and orphan-drug exclusivity regimes.

Exclusivity category	Current position
New chemical entity exclusivity	None
Five-year approval exclusivity	Not applicable to this legacy product
Three-year clinical exclusivity	None
Orphan-drug exclusivity	None
Pediatric exclusivity	None
Patent-based exclusivity	No commercially meaningful unexpired estate identified
Generic substitution risk	High

Because promethazine and codeine are long-established active ingredients, generic manufacturers do not need to overcome the type of scientific and patent-development burden faced by a modern novel drug. The principal generic hurdle is regulatory compliance with the product’s formulation, bioequivalence, manufacturing controls, controlled-substance requirements, and labeling.

What patents protect Phenergan with Codeine?

No material unexpired patent protection is associated with the legacy Phenergan with Codeine product. The formulation is technically straightforward compared with extended-release opioids, inhaled products, biologics, or complex injectable systems.

Potential historical patent categories would have included:

• Combination composition claims.
• Oral-solution formulation claims.
• Manufacturing or stability claims.
• Method-of-use claims for cough or respiratory symptoms.

Those categories do not provide a meaningful current exclusivity position for the brand. The absence of a complex delivery system also limits the possibility of using formulation patents to delay generic entry.

How strong is the patent estate for Phenergan with Codeine?

The patent estate is weak from a current commercial perspective.

Patent-strength factor	Assessment
Core active ingredients	Very weak; both are long-established
Combination formulation	Weak; generic oral solutions are established
Delivery technology	Weak; conventional liquid dosage form
Method of use	Weak; broad cough indications are old
Manufacturing barriers	Moderate operational barrier, but not a patent barrier
Litigation leverage	Low
Lifecycle-management potential	Limited

A generic applicant could face manufacturing and regulatory execution risks, but those risks are different from patent-based market exclusion. No major Paragraph IV litigation campaign is associated with the legacy brand in the current market.

Which companies are challenging Phenergan with Codeine?

Generic manufacturers have challenged the product commercially through abbreviated new drug approvals rather than through a high-profile patent dispute. The U.S. market has included generic promethazine hydrochloride and codeine phosphate oral solutions from multiple suppliers over time, including manufacturers and marketers in the generic sector such as Hi-Tech Pharmacal, Akorn, Perrigo, Rising Pharmaceuticals, and other ANDA holders or private-label distributors.

Supplier participation has fluctuated because of:

• Controlled-substance compliance costs.
• Manufacturing interruptions.
• FDA inspections and remediation.
• Raw-material availability.
• Wholesaler purchasing decisions.
• Opioid demand reduction.
• State-level prescribing restrictions.

The relevant competitive question is not whether a generic can legally enter. It is whether a supplier can maintain reliable production and secure pharmacy, wholesaler, and payer access.

What generic entry risks exist for Phenergan with Codeine?

Generic entry risk is effectively established rather than prospective. Generic products compete through substitution and lower net pricing. The main commercial risks to the brand are:

1. Pharmacy substitution under state generic-substitution laws.
2. Formulary preference for lower-cost generic products.
3. Reduced prescriber use of opioid cough medicines.
4. Payer controls and prior authorization.
5. Pharmacy refusal or restricted dispensing of opioid cough products.
6. Product shortages that periodically shift share among suppliers.

A generic launch scenario would therefore not resemble a single “first entrant” event. The market has the characteristics of a mature multi-supplier generic category. Price erosion is constrained in some periods by limited supplier participation, but demand erosion is a larger structural issue.

What regulatory actions have affected the market?

FDA and state opioid policies have materially reduced the addressable market.

In 2017, FDA required labeling changes for prescription codeine and tramadol products in children. In 2018, FDA extended the action to prescription opioid cough-and-cold medicines, limiting use to adults 18 and older.[2]

The labeling includes a boxed warning covering addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal; and interactions with benzodiazepines or other central nervous system depressants.[1]

Promethazine also carries respiratory-depression concerns, particularly in young children. The combination of promethazine and codeine creates a risk profile that is less favorable than non-opioid cough products for many patients.

State controls can be stricter than federal requirements. States have imposed additional limits on opioid cough medicines, including restrictions involving minors, quantity, duration, prescribing practices, and monitoring. Pharmacies and wholesalers have also adopted internal opioid-controls policies that can reduce dispensing even when the prescription is legally valid.

What is the financial trajectory of Phenergan with Codeine?

Phenergan with Codeine is a declining or low-growth mature product rather than a strategic growth asset. Pfizer does not separately disclose revenue for the product in its public filings. It reports large business segments and product groups, but Phenergan with Codeine is not identified as a standalone revenue line.[4]

Revenue exposure

Financial factor	Effect on product economics
Brand pricing power	Low
Patent protection	None of practical importance
Generic substitution	High
Opioid demand	Declining
Pediatric demand	Reduced by FDA restrictions
Manufacturing complexity	Relatively low
Compliance burden	High relative to product value
Public revenue disclosure	Not separately reported
Strategic importance to Pfizer	Low based on portfolio disclosure

Revenue has likely been pressured by four forces: generic competition, lower opioid prescribing, regulatory restrictions, and pharmacy reluctance to dispense opioid cough products. Any remaining brand revenue would depend on physician familiarity, patient preference, supply availability, and reimbursement differences rather than exclusivity.

The product can remain commercially relevant in a narrow cash-pay or legacy-prescribing segment, but its economic profile is materially weaker than that of patented specialty medicines. Established generic products can still generate revenue when supplier competition is limited, yet the brand lacks a clear mechanism for sustained premium pricing.

What manufacturing and intellectual-property barriers remain?

Manufacturing is a more relevant barrier than intellectual property.

A supplier must control:

• Codeine and promethazine raw materials.
• Controlled-substance inventory and recordkeeping.
• Oral-solution uniformity.
• Microbial quality and preservative performance.
• Stability across the labeled shelf life.
• Packaging and child-resistant closure requirements.
• FDA current good manufacturing practice compliance.
• DEA registration and quota-related controls.

These requirements can cause shortages or supplier exits, but they do not confer market exclusivity. A formulation manufacturer with reliable supply, compliant facilities, and wholesaler relationships can compete without owning the brand.

How does Phenergan with Codeine compare with non-opioid cough products?

Market factor	Phenergan with Codeine	Dextromethorphan products	Benzonatate products
Opioid exposure	Yes	No	No
Federal controlled-substance controls	Yes, under applicable formulation	No	No
Pediatric restrictions	Strong restrictions	Product-specific	Product-specific
Abuse and diversion risk	High	Lower	Lower, but ingestion risks exist
Generic competition	Established	Extensive	Established
Prescribing trend	Under pressure	More resilient	More resilient
Payer and pharmacy friction	High	Lower	Lower

The competitive market has shifted toward non-opioid cough products when clinical circumstances permit. Promethazine-codeine retains use in selected adult prescriptions, but its risk and compliance profile limits volume growth.

What litigation and settlement agreements affect the product?

No major current patent litigation or settlement agreement is central to the commercial outlook for Phenergan with Codeine. The product’s competitive position is not protected by a pending patent case, and no meaningful generic-entry settlement is required to explain market access.

The broader opioid litigation environment affects manufacturers, distributors, and pharmacies. Those proceedings have increased compliance costs and scrutiny across opioid products, but they do not restore exclusivity to Phenergan with Codeine.[5]

Is there biosimilar risk for Phenergan with Codeine?

No. Biosimilar risk does not apply because Phenergan with Codeine is a conventional small-molecule oral solution, not a biologic. The relevant competition is from generic ANDA products, not biosimilars under the Biologics Price Competition and Innovation Act.

What is the geographic coverage of Phenergan with Codeine?

The key market is the United States, where the product is subject to FDA, DEA, state pharmacy, and opioid-prescribing controls. International markets use different brand names, formulations, controlled-substance schedules, and regulatory standards. U.S. patent and exclusivity analysis cannot be transferred directly to Canada, Europe, or other jurisdictions.

The product’s geographic commercial opportunity is constrained by country-specific opioid controls. Some markets prohibit or tightly restrict codeine cough products, while others permit them under prescription or pharmacy controls.

Key Takeaways

• Phenergan with Codeine is a legacy promethazine-codeine oral solution with no meaningful current patent or regulatory exclusivity.
• The product’s FDA labeling restricts prescription opioid cough-and-cold use to adults 18 and older.
• Generic competition is established, and Paragraph IV litigation is not the central market issue.
• Pfizer does not separately report Phenergan with Codeine revenue.
• Product economics are pressured by generic substitution, lower opioid prescribing, pharmacy controls, and compliance costs.
• Manufacturing reliability and controlled-substance compliance are more important barriers than intellectual property.
• No biosimilar risk applies; the relevant threat is generic substitution.
• The product has limited strategic growth potential unless supply disruption or a narrow premium channel temporarily supports pricing.

FAQs

Is Phenergan with Codeine still commercially available?

Availability varies by manufacturer, wholesaler inventory, pharmacy policy, and local controlled-substance restrictions. The brand and generic market should be assessed separately because an FDA-approved NDA does not guarantee continuous retail availability.

Does Phenergan with Codeine have an Orange Book patent?

The legacy product has no commercially meaningful unexpired patent position identified for blocking generic competition. Current Orange Book records should be used for the latest application, patent, and marketing-status entries.[3]

Can a generic manufacturer launch Phenergan with Codeine without a Paragraph IV challenge?

Yes. If no unexpired listed patent blocks approval, an ANDA applicant can proceed through the applicable generic approval pathway without relying on a Paragraph IV patent certification.

Why has demand for promethazine-codeine declined?

Demand has been affected by opioid safety concerns, FDA pediatric restrictions, state prescribing rules, pharmacy controls, payer management, and increased use of non-opioid cough products.

Is Phenergan with Codeine a high-value licensing asset?

Its licensing value is limited. A transaction would be more likely to reflect supply capability, distribution access, or a broader established-products portfolio than patent rights or durable pricing power.

References

1. U.S. Food and Drug Administration. (2019). Phenergan with Codeine oral solution prescribing information. Wyeth Pharmaceuticals LLC. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008306s034lbl.pdf

2. U.S. Food and Drug Administration. (2018, January 11). FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. https://www.fda.gov/news-events/press-announcements/fda-requires-labeling-changes-prescription-opioid-cough-and-cold-medicines-limit-their-use

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA and Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/

4. Pfizer Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. https://www.pfizer.com/investors/financial-reports

5. U.S. Department of Justice. (2022, October 20). Justice Department announces resolution of opioid litigation with major pharmaceutical distributor. https://www.justice.gov/opa/pr/justice-department-announces-resolution-opioid-litigation-major-pharmaceutical-distributor