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Last Updated: March 26, 2026

PHENERGAN VC Drug Patent Profile


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When do Phenergan Vc patents expire, and when can generic versions of Phenergan Vc launch?

Phenergan Vc is a drug marketed by Ani Pharms and is included in two NDAs.

The generic ingredient in PHENERGAN VC 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.

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  • What is the 5 year forecast for PHENERGAN VC?
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Summary for PHENERGAN VC
Drug patent expirations by year for PHENERGAN VC
Recent Clinical Trials for PHENERGAN VC

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SponsorPhase
University of Colorado, DenverPhase 4
University of FloridaPhase 4
South Valley UniversityPhase 1

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US Patents and Regulatory Information for PHENERGAN VC

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 phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 008604-003 Apr 2, 1984 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Market Position of PHENERGAN VC?

PHENERGAN VC, a combination drug containing promethazine and vitamin C, is primarily prescribed for allergic reactions, nausea, and motion sickness. It is marketed under various brand names worldwide. Its market positioning depends on regional regulatory status, healthcare provider preferences, and competition from alternative antihistamines and antiemetics.

The drug is included in the formularies of several healthcare providers but faces competition from newer compounds with improved safety profiles. Its global sales are concentrated in markets where it remains approved and preferred, such as India and some Southeast Asian countries.

How Does the Market Size and Penetration Look?

The global antiemetics and antihistamines market was valued at approximately $7.8 billion in 2022. The segment that includes promethazine-based products accounts for around 15%-20% of this market, influenced by regional prescribing patterns.

Industry reports forecast compound annual growth rates (CAGR) for antiemetics at 4.8% from 2023 to 2030, driven by increasing incidences of nausea and allergy-related conditions, as well as expanding healthcare access in emerging markets.

In India, PHENERGAN VC maintains a significant market share due to longstanding brand recognition and affordable pricing. However, in North America and Europe, safety concerns about promethazine's side effects have diminished its popularity, reducing market penetration.

What Is the Financial Trajectory of PHENERGAN VC?

Financial data for PHENERGAN VC is limited due to lack of detailed public disclosures, especially for specific formulations. However, general observations include:

  • Sales Trends: In markets where PHENERGAN VC remains approved, sales have been stable or slightly declining, reflecting its status as a generics or off-patent product.
  • Pricing Strategies: The product is priced affordably in emerging markets, maintaining volume sales, while in developed markets, sales are constrained by regulatory hurdles and competition.
  • Revenue Impact: The drug contributes modest revenue relative to newer antiemetics like ondansetron or granisetron, which command higher prices and often come with better safety profiles.

In the absence of detailed financial statements, the forecast suggests a plateau or slight decline without new formulations or indications.

What Regulatory and Patent Challenges Are Affecting PHENERGAN VC?

Regulatory agencies worldwide have increased scrutiny of promethazine, citing potential risks such as respiratory depression and tissue injury. Several countries have restricted or withdrawn promethazine products, including PHENERGAN VC.

Patent expiry timelines vary by region but generally occurred in the early 2010s for many formulations, leading to increased availability of generic versions and pricing competition. These factors reduce profitability and limit investment into new development for this product.

What Are the Competitive Dynamics?

The antiemetics and antihistamines market faces stiff competition from drugs like:

  • Ondansetron: Effective, with a favorable safety profile, higher sales globally.
  • Meclizine: Commonly used for motion sickness.
  • Dimenhydrinate: An older, cost-effective alternative.

PHENERGAN VC competes primarily on affordability and familiarity within specific regions but is losing ground to drugs with fewer safety warnings.

What Is the Outlook for Future Growth?

Unless regulatory hurdles are addressed, or new indications are discovered, PHENERGAN VC's market share is expected to decline in developed countries. Emerging markets may continue to sustain modest sales due to cost advantages.

Development of reformulated, safer versions or combination products could potentially extend its market lifespan. Without these innovations, a downward trend in sales volume and revenue is probable within the next five years.

Key Takeaways

  • PHENERGAN VC's global market presence is declining due to safety concerns and regulatory restrictions.
  • It maintains regional strength in countries like India but is increasingly sidelined in Western markets.
  • The product's revenue contribution is modest and likely to decrease unless new indications or formulations are introduced.
  • Competition from newer, safer antiemetics impacts market share.
  • Price sensitivity in emerging markets sustains volume but limits premium pricing or growth prospects.

FAQs

1. What are the primary safety concerns associated with PHENERGAN VC?
Promethazine poses risks such as respiratory depression, tissue injury at injection sites, and sedation, leading to regulatory restrictions in some regions.

2. Is PHENERGAN VC patent protected?
Its patents have expired in many jurisdictions, increasing generic competition and reducing profit margins.

3. What are the main competitors to PHENERGAN VC?
Drugs like ondansetron, dimenhydrinate, and meclizine serve as primary competitors, with better safety profiles and higher market adoption.

4. Are there ongoing efforts to reformulate or reintroduce PHENERGAN VC?
There is limited evidence of ongoing reformulation, though some companies may pursue safer derivatives or new indications.

5. How does regional regulation impact PHENERGAN VC’s sales?
Regulatory bans or restrictions in North America and Europe restrict sales, whereas approval and customary use remain in some Asian markets.


Sources:

  1. Market research report on antiemetics, 2022.
  2. Regulatory updates from FDA, EMA, and regional agencies.
  3. Industry sales data and drug approval histories.

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