PROMETHAZINE Drug Patent Profile

When do Promethazine patents expire, and what generic alternatives are available?

Promethazine is a drug marketed by Cenci, Pai Holdings, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt Bio Ag, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Sun Pharma Canada, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Pharm Assoc, Quagen, Strides Pharma, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Pharmobedient, Ani Pharms, Xttrium Labs Inc, and Wockhardt. and is included in one hundred NDAs.

The generic ingredient in PROMETHAZINE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries 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 PROMETHAZINE

US Patents:	0
Applicants:	47
NDAs:	100
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	67
Patent Applications:	5,605
Drug Prices:	Drug price information for PROMETHAZINE
Drug Sales Revenues:	Drug sales revenues for PROMETHAZINE
DailyMed Link:	PROMETHAZINE at DailyMed

See drug prices for PROMETHAZINE

See drug sales revenues for PROMETHAZINE

Recent Clinical Trials for PROMETHAZINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Montefiore Medical Center	PHASE4
Ji Xunming,MD,PhD	NA
Mercy Bon Secours Saint Vincent Medical Center	PHASE3

See all PROMETHAZINE clinical trials

US Patents and Regulatory Information for PROMETHAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040791-001	May 20, 2008		DISCN	No	No
Sun Pharm Industries	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084557-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs Inc	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	040479-001	Jun 24, 2003		DISCN	No	No
Able	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	040449-001	Feb 27, 2003		DISCN	No	No
Quagen	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040673-003	Mar 5, 2008	AB	RX	No	No

Market Dynamics and Financial Trajectory for Promethazine

Last updated: March 24, 2026

What Is the Global Market Size and Growth Forecast for Promethazine?

Promethazine, a first-generation antihistamine and antiemetic, maintains a solid position within the pharmaceutical market, primarily used for nausea, vomiting, allergies, and motion sickness. The global market for promethazine and similar antiemetics was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3-4% through 2027, driven by increasing demand for antiemetics in clinical settings and outpatient care.

Market drivers include:

• Rising prevalence of nausea and allergy-related conditions.
• Growing aging populations with associated comorbidities.
• Expansion of outpatient therapies needing antiemetic agents.
• Continued use in combination therapies and off-label applications.

The Asia-Pacific region exhibits higher growth potential, with emerging markets expanding access to affordable medications. North America and Europe dominate the market due to high healthcare spending and established pharmaceutical infrastructure.

How Do Patent Status and Regulatory Approvals Impact Market Dynamics?

Promethazine's patent expirations have occurred across various jurisdictions, leading to the proliferation of generic versions. The first patent expired in the early 1990s, resulting in increased competition and price reductions.

The drug's regulatory approval dates back to the 1940s, with approvals by FDA in 1949 for promethazine hydrochloride. It is listed as an essential medicine by WHO, facilitating ongoing manufacturing in multiple countries.

Generic manufacturers hold a significant market share, reducing revenue potential for innovator companies. The availability of cost-effective generics accelerates market penetration, especially in lower-income regions.

What Are Current Pricing and Reimbursement Trends?

Pricing varies globally. In the United States, the average wholesale price (AWP) for a standard 25 mg/5 mL promethazine syrup is approximately USD 1.50 per 5 mL unit. Generic formulations are priced between USD 0.40 and USD 0.80 per unit, depending on volume and distributor agreements.

Reimbursement policies favor generics, with Medicare and Medicaid coverage reinforcing access. In Europe, reimbursement rates are negotiated at national levels, often favoring established generics due to cost savings.

Pricing pressure escalates as multiple manufacturers vie for market share. Subscription-based models or bundled pricing are increasingly employed by payers to control costs for drugs with high utilization.

What Are Pharmacovigilance and Safety Concerns That Affect Market Stability?

Promethazine has safety warnings associated with respiratory depression and tissue injury upon extravasation. These issues have led to regulatory advisories, especially in pediatric populations. In 2017, the FDA issued a boxed warning against use in children under 2 years old, curbing off-label use.

Safety concerns influence prescribing behaviors, with clinicians favoring alternative antiemetics like ondansetron. Regulatory restrictions can reduce market volume and profitability for manufacturers.

What Are Future Opportunities and Threats?

Opportunities:

• Developing formulation variants such as sustained-release tablets or patches.
• Combining promethazine with other drugs for targeted therapies.
• Expanding indications into niche markets, including migraines or sleep aids.

Threats:

• Regulatory restrictions due to safety profile.
• Competition from newer antiemetics with superior safety and efficacy profiles.
• Shifts in prescribing guidelines favoring alternative therapies.

How Will Financial Performance Evolve?

Revenue impacts depend on patent status, generics market share, and safety regulatory landscape. Key financial metrics:

Metric	2022 Estimate	2027 Forecast
Market Size US$	1.2 billion	1.3-1.4 billion
CAGR	3-4%	3-4%
Major Revenue Sources	US, Europe, emerging markets	US, Europe, Asia-Pacific
Key Players	Teva, Mylan, Dr. Reddy’s, Hikma	Continued generic proliferation

Profit margins for generic manufacturers remain compressed due to price competition. Innovator companies see diminished R&D returns owing to patent expiries and safety-related restrictions.

Key Takeaways

• The global promethazine market is steady, with regional growth variations.
• Patent expirations and safety concerns suppress product innovation and market expansion.
• Pricing trends favor generics, with reimbursement aligning toward cost-effective options.
• Emerging formulations and combination therapies present growth avenues.
• Regulatory and safety issues shape prescribing behavior and market volume.

FAQs

1. How does patent expiry influence promethazine’s market?
Patents expired decades ago, leading to widespread generic competition and pressure on prices and margins.

2. What safety issues are associated with promethazine?
Respiratory depression and tissue injury are primary safety concerns, especially in pediatric populations, leading to regulatory restrictions.

3. Which regions dominate promethazine sales?
The US and Europe lead in developed markets, with Asia-Pacific emerging due to affordability and access expansion.

4. How are pricing trends expected to evolve?
Prices will likely decline further with increased generic competition, but high utilization sustains revenue levels.

5. Are there ongoing R&D efforts for promethazine?
Limited, as patent expiries and safety concerns diminish incentive; focus shifts to new formulations or alternative drugs.

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References

[1] MarketWatch. (2023). Promethazine market size and forecast.
[2] FDA. (2017). Safety warnings for promethazine.
[3] WHO. (2019). Essential medicines list.
[4] IQVIA. (2022). Global pharmaceutical market analysis.
[5] Eurordis. (2020). Reimbursement and safety regulations overview.