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Last Updated: March 30, 2025

PROMETHAZINE Drug Patent Profile


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

Promethazine is a drug marketed by Cenci, Slate Run Pharma, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Xttrium Labs Inc. 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. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

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Drug patent expirations by year for PROMETHAZINE
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Recent Clinical Trials for PROMETHAZINE

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SponsorPhase
National Trauma CenterN/A
Oman Medical Speciality BoardPhase 3
Tanta UniversityN/A

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US Patents and Regulatory Information for PROMETHAZINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Able PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040449-001 Feb 27, 2003 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs Inc PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040479-001 Jun 24, 2003 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms Usa PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040596-001 Nov 18, 2005 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharm Assoc PROMETHAZINE WITH CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 040650-001 Jan 31, 2006 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Impax Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040791-001 May 20, 2008 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pvt Form PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083658-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm Industries PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084557-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory of Promethazine

Introduction to Promethazine

Promethazine, a phenothiazine derivative, is a versatile antihistamine used in various therapeutic applications, including allergy relief, motion sickness treatment, and preoperative sedation. Its widespread use and effectiveness in managing nausea and vomiting, particularly in surgical and chemotherapy settings, have made it a crucial component in both clinical and outpatient care.

Market Size and Growth Prospects

The promethazine HCl market is anticipated to experience significant growth, driven by several key factors. By 2031, the market is expected to reach a valuation of USD 11.3 billion, up from USD 6.6 billion in 2024, with a compound annual growth rate (CAGR) of 7.99%[1].

Therapeutic Applications and Demand Drivers

Promethazine's extensive use in various therapeutic areas is a major driver of market growth. Here are some key applications:

  • Allergy Relief and Respiratory Conditions: The rising prevalence of allergies and respiratory conditions has increased the demand for effective antihistamines like promethazine[1].
  • Motion Sickness and Nausea: Its effectiveness in treating motion sickness and managing nausea and vomiting, especially in surgical and chemotherapy settings, further boosts demand[1].
  • Preoperative Sedation: The need for medications that provide symptom relief during surgical procedures also contributes to market growth[1].

Market Drivers

Several factors are driving the growth of the promethazine HCl market:

  • Increasing Healthcare Spending: The rise in healthcare spending and the expansion of the pharmaceutical sector are key drivers. More healthcare providers are incorporating promethazine HCl into their treatment protocols[1].
  • Patient-Centered Care: The growing focus on patient-centered care and the need for effective medications during surgical procedures also contribute to market growth[1].
  • Regulatory Support: Regulatory support for the safe and effective use of promethazine HCl in diverse medical contexts further strengthens the market[1].
  • Urbanization and Demographics: The rising urban population, especially in regions like Asia-Pacific, is propelling the demand for promethazine HCl due to increased healthcare needs in urban centers[1].

Regional Market Analysis

The global promethazine HCl market is segmented across various regions, each with its unique dynamics:

  • Asia-Pacific: This region is experiencing rapid growth driven by countries like China, Japan, India, and South Korea. Factors such as a large population, rising disposable income, and increasing urbanization are driving demand[1].
  • Europe: Europe is a mature market with well-established infrastructure and consumer preferences. Countries like the UK, Germany, France, and Italy are key players in this region[1].
  • Latin America: This region presents both opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players. Economic fluctuations and political instability can impact market dynamics[1].
  • Middle East and Africa: These regions represent emerging markets with countries like UAE, Saudi Arabia, South Africa, and Nigeria showing promising growth potential due to economic diversification, urbanization, and a young population[1].

Competitive Landscape and Key Players

The promethazine HCl market is characterized by a competitive landscape with several key players:

  • Manus Aktteva Biopharma LLP
  • EUROAPI
  • Guangzhou Isun Pharmaceutical
  • Shanghai Canbi Pharma
  • Kono Chem

These companies are known for their market strengths, product portfolios, and strategic initiatives such as mergers and acquisitions to consolidate their market positions and leverage synergies[1].

Mergers and Acquisitions

The market is witnessing a wave of mergers and acquisitions as companies seek to expand their product portfolios, access new technologies, and enhance their competitiveness. These strategic consolidations enable companies to innovate faster and stay ahead of market trends[1].

Access to New Technologies

Acquisitions provide companies with access to new technologies, intellectual property, and talent, which are crucial for innovation and staying competitive in the market. This access helps companies to innovate faster and adapt to changing market conditions[1].

Financial Trajectory and Cost Considerations

The cost of promethazine can vary based on several factors, including the form of the drug, treatment plan, insurance coverage, and the pharmacy used.

  • Form of the Drug: Promethazine is available in various forms such as oral tablets, oral syrup, rectal suppositories, and injections. The price varies depending on the form prescribed by the doctor[2].
  • Insurance Coverage: The cost is significantly influenced by insurance coverage. Generic versions of promethazine tend to be more affordable than brand-name versions like Promethegan[2].
  • Long-term Cost Savings: Options such as getting a 90-day supply of the drug can reduce the number of trips to the pharmacy and help lower the overall cost[2].

Impact of Regulatory Changes

Recent regulatory changes, such as those introduced by the Inflation Reduction Act, are expected to impact the financial trajectory of prescription drug spending, including promethazine. These provisions aim to cap out-of-pocket drug spending, require pharmaceutical manufacturers to pay rebates if prices rise faster than inflation, and allow the federal government to negotiate prices for certain high-spend drugs covered by Medicare[3].

Consumer Behavior and Affordability

Consumer behavior and affordability play significant roles in the market dynamics. According to recent polls, more than 1 in 4 adults taking prescription drugs report difficulty affording their medication, highlighting the need for cost-effective solutions[3].

Key Takeaways

  • The promethazine HCl market is expected to grow significantly, reaching a valuation of USD 11.3 billion by 2031.
  • The market is driven by its extensive use in therapeutic applications, increasing healthcare spending, and regulatory support.
  • Regional dynamics vary, with Asia-Pacific and Europe being key regions.
  • Mergers and acquisitions are common as companies seek to consolidate and innovate.
  • The cost of promethazine varies based on the form of the drug and insurance coverage.
  • Regulatory changes are expected to impact out-of-pocket drug spending.

Frequently Asked Questions (FAQs)

1. What is the current market size and future growth prospects of the promethazine HCl market?

  • The promethazine HCl market is anticipated to grow from USD 6.6 billion in 2024 to USD 11.3 billion by 2031, with a CAGR of 7.99%[1].

2. What are the primary therapeutic applications of promethazine?

  • Promethazine is used for allergy relief, motion sickness treatment, preoperative sedation, and managing nausea and vomiting, especially in surgical and chemotherapy settings[1].

3. How does insurance coverage affect the cost of promethazine?

  • Insurance coverage significantly influences the cost of promethazine. Generic versions tend to be more affordable than brand-name versions, and getting a 90-day supply can help lower costs[2].

4. What impact do regulatory changes have on the promethazine market?

  • Regulatory changes, such as those introduced by the Inflation Reduction Act, aim to cap out-of-pocket drug spending and require pharmaceutical manufacturers to pay rebates if prices rise faster than inflation, which can affect the financial trajectory of the market[3].

5. Which regions are expected to drive the growth of the promethazine HCl market?

  • The Asia-Pacific region, driven by countries like China, Japan, India, and South Korea, is expected to be a significant driver of market growth due to its large population, rising disposable income, and increasing urbanization[1].

Cited Sources:

  1. OpenPR: Promethazine HCL Market Size, Share and Forecast By Key Players.
  2. Medical News Today: Promethazine cost 2024: Coupons and more.
  3. Health System Tracker: What are the recent and forecasted trends in prescription drug spending?
  4. Cognitive Market Research: Global Promethazine Hydrochloride Market Report 2024 Edition.
  5. Drug Patent Watch: Promethazine hydrochloride - Generic Drug Details.

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