PHENERGAN VC Drug Patent Profile

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.

Summary for PHENERGAN VC

US Patents:	0
Applicants:	1
NDAs:	2

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
Ani Pharms	PHENERGAN VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	008306-005	Apr 2, 1984		DISCN	Yes	No

Summary:
PHENERGAN VC, a combination product containing promethazine and codine (or other similar formulations), is marketed primarily for allergic conditions, nausea, and vomiting. Its investment prospects depend on patent status, regulatory environment, market competition, and potential for new indications. Currently, PHENERGAN VC faces patent expiration risks, regulatory scrutiny, and competitive challenges from generics and alternative therapies. Its future depends on legal exclusivities and pipeline developments.

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What Is the Market Position and Patent Status of PHENERGAN VC?
PHENERGAN VC is marketed under various brand names, with actual formulations shifting based on regional licensing and patent survivability.

• Patent Timeline:
  Most formulations, including promethazine combinations, have faced patent expirations over the past decade. U.S. patents for promethazine products generally expired around 2010-2015, with some secondary patents possibly extending exclusivity until 2018-2020 in select jurisdictions. Worldwide patent status varies.

• Market Exclusivity:
  The product's exclusivity relies on formulation patents, process patents, and regulatory exclusivities. A lack of remaining patent protection limits pricing power and market share, increasing generic competition.

• Regulatory Data:
  The FDA approved generic versions after patent expiry, reducing revenue and profitability margins. No new formulations or indications appear to have been approved since the original patent protections expired.

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What Are the Key Factors Impacting Investment and Fundamentals?

Last updated: February 3, 2026

• Patent and Regulatory Environment:
  Loss of patent protection leads to revenue decline. The expiration date of primary patent rights predates 2017, suggesting limited mainline proprietary advantages in current markets.

• Market Competition:
  Multiple generics are available for promethazine in the U.S. and Europe. The presence of low-cost generics suppresses prices and margins.

• Indications and Commercial Potential:
  Primarily used for allergic conditions and nausea. Limited new indications or formulations under development. The age of the product diminishes growth potential unless new uses emerge.

• Legal and Regulatory Risks:
  Increased scrutiny over promethazine's safety profile, especially regarding pulmonary and tissue damage, may lead regulatory restrictions or label warnings, decreasing uptake.

• Pipeline Developments:
  No significant pipeline investments or novel formulations announced. Potential value could emerge from new, patent-protected combinations or delivery mechanisms.

• Pricing Trends and Market Size:
  The global market for antihistamines and antiemetics is sizable but highly commoditized. Revenue for older products like PHENERGAN VC deteriorates as generics dominate.

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Financial Metrics and Investment Considerations

Aspect	Status	Implication
Patent Expiry	Past (2010–2020 depending on jurisdiction)	Revenue decline as generics enter
Revenue	Historically substantial, now declining	Investment entry at risk of low-margin commoditization
Profit Margins	Narrowing, with profit erosion due to competition	Reduced attractiveness for licensing or acquisition
R&D Pipeline	Minimal or absent	Limited upside potential
Market Share	Shrinking post-patent expiry	Challenges in differentiation

Growth outlook: Negative without innovation or new indications supporting patent protection or exclusivity.

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Summary of Investment Fundamentals

• The product’s core patents expired years ago, making it vulnerable to generic competition globally.
• The current market relies predominantly on off-patent formulations with declining revenue streams.
• Without strategic pipeline development, long-term growth prospects remain limited.
• Regulatory scrutiny could further suppress demand or increase compliance costs.
• Market dynamics favor lower-cost generics, pressuring pricing and margins.

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Key Takeaways:

• PHENERGAN VC's patent expiration and generic competition limit its growth prospects.
• The product has minimal pipeline activity, reducing potential for future revenue streams.
• Regulatory environment risks may further impact sales or market access.
• Investment in the product should consider the current commoditized market landscape.
• Potential value could stem from new formulations or indications, but none are currently in development.

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FAQs

1. Is PHENERGAN VC a good long-term investment?
   No; patent expiration and generic competition limit long-term profitability unless new formulations or indications emerge.

2. What factors could improve its future prospects?
   Development of new, patent-protected formulations or alternative delivery systems that address compliance or safety issues.

3. Are there regulatory risks associated with PHENERGAN VC?
   Yes; safety concerns and label warnings could restrict use or lead to reduced prescribing.

4. Can licensing or acquisition provide upside?
   Only if the buyer secures rights to formulations with remaining exclusivities or develops innovative applications.

5. How does market competition affect pricing?
   Generics dominate, leading to low prices and narrow profit margins for brand-name products.

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Citations

1. U.S. Patent and Trademark Office, Patent Expiry Dates (2010–2020).
2. FDA Drugs@FDA Database, Approvals and Labeling Information.
3. Market Research Reports, Global Anti-Emetics Market Size and Trends (2022).
4. Regulatory Filings and Safety Communications, Promethazine Safety Profile (2021).
5. Industry Reports, Post-Patent Attrition in Antihistamines (2022).