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Last Updated: December 22, 2024

PROMETHAZINE DM Drug Patent Profile


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Which patents cover Promethazine Dm, and when can generic versions of Promethazine Dm launch?

Promethazine Dm is a drug marketed by Slate Run Pharma and is included in one NDA.

The generic ingredient in PROMETHAZINE DM is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

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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 DM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Slate Run Pharma PROMETHAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040649-001 Feb 14, 2006 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PROMETHAZINE DM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Promethazine DM

Introduction

Promethazine DM, a combination of the antihistamine promethazine and the cough suppressant dextromethorphan, is widely used to treat symptoms associated with allergies and the common cold. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients alike.

Market Demand and Usage

Promethazine DM is in high demand due to its effectiveness in reducing coughing and other symptoms related to allergies and the common cold. The drug is commonly prescribed and used by a broad demographic, including children and adults[4].

Prescription and Insurance Coverage

The drug is typically covered by health insurance and Medicaid, which helps in maintaining a steady demand. However, Medicare Part D may not cover promethazine DM due to potential side effects in older adults, such as respiratory depression and blood pressure changes[2].

Cost and Pricing

Without insurance, a 118 mL bottle of promethazine DM syrup, which usually lasts for 7 days, costs approximately $32. However, using prescription discount cards, such as those from SingleCare, can significantly reduce the cost to around $2. Price shopping at different pharmacies can also yield savings, with some pharmacies offering the same bottle for as low as $12[2].

Generic Availability and Alternatives

Promethazine DM is available in generic form, which helps in reducing costs for patients. Other prescription alternatives include promethazine-codeine and chlorpheniramine-codeine, though these have different side effects and drug interactions. Benzonatate is another option for cough suppression but does not include an antihistamine and is generally more expensive[2].

Side Effects and Safety Concerns

The drug's side effect profile, which includes drowsiness, nausea, and potential severe allergic reactions, can impact its market dynamics. Serious side effects such as breathing problems, neuroleptic malignant syndrome, and movement problems are rare but significant concerns that healthcare providers must consider[4].

Competitive Landscape

Promethazine DM competes with other cough and cold medications such as Mucinex (guaifenesin) and Benzonatate. While Promethazine DM has a moderate user satisfaction rating of 5.6 out of 10, Mucinex has a slightly higher rating of 6.2 out of 10, and Benzonatate has a lower rating of 4.1 out of 10[5].

Financial Trajectory

The financial trajectory of promethazine DM is influenced by several factors:

Revenue Streams

  • Prescription Sales: The drug generates significant revenue through prescription sales, particularly during peak cold and flu seasons.
  • Insurance Coverage: The coverage by health insurance and Medicaid contributes substantially to the revenue.
  • Discount Programs: Programs like SingleCare help in increasing the accessibility and affordability of the drug, potentially boosting sales volume[2].

Cost Savings

  • Generic Versions: The availability of generic versions reduces production costs and increases profit margins for manufacturers.
  • Price Comparisons: Patients and healthcare providers who compare prices across different pharmacies can find better deals, which may impact the revenue of specific pharmacies but overall helps in maintaining market stability[2].

Market Growth

The market for promethazine DM is relatively stable due to its established use and the consistent demand for cold and allergy medications. However, growth can be influenced by factors such as new drug developments, changes in insurance coverage policies, and public health trends.

Challenges and Opportunities

Abuse and Misuse

Promethazine has been associated with misuse and addiction, which can negatively impact its market dynamics. Addressing this issue through education and stricter prescribing practices is crucial[1].

Regulatory Changes

Changes in regulatory policies, such as those related to opioid-containing alternatives, can affect the market. For instance, promethazine-codeine combinations may face stricter regulations due to the opioid component[2].

Innovations and Alternatives

The development of new, safer alternatives could pose a challenge to promethazine DM's market share. However, innovations in delivery methods or formulations could also present opportunities for growth.

Consumer Behavior and Preferences

Consumer behavior plays a significant role in the market dynamics of promethazine DM. Patients often prefer medications that are effective, affordable, and have minimal side effects. The rise of telemedicine and online pharmacies has also changed how patients access and purchase medications, potentially impacting sales channels and revenue streams.

Healthcare Provider Influence

Healthcare providers' prescribing habits significantly influence the market. Their decisions are based on the drug's efficacy, safety profile, and cost. Educational campaigns and clinical guidelines can shape these decisions and impact the drug's financial trajectory.

Key Takeaways

  • Stable Demand: Promethazine DM has a consistent demand due to its effectiveness in treating common cold and allergy symptoms.
  • Insurance Coverage: The drug is generally covered by health insurance, but Medicare Part D may have limitations.
  • Cost and Savings: The cost can be significantly reduced through discount programs and price comparisons.
  • Generic Availability: Generic versions are available, reducing production costs and increasing accessibility.
  • Challenges: Misuse, regulatory changes, and the development of new alternatives are key challenges.
  • Opportunities: Innovations in delivery methods and formulations, as well as changes in consumer behavior, present opportunities for growth.

FAQs

  1. Is promethazine DM covered by insurance? Yes, promethazine DM is typically covered by health insurance and Medicaid, though Medicare Part D may not cover it due to potential side effects in older adults[2].

  2. How much does promethazine DM cost without insurance? Without insurance, a 118 mL bottle of promethazine DM syrup costs approximately $32, but can be reduced to around $2 with a prescription discount card[2].

  3. What are the common side effects of promethazine DM? Common side effects include drowsiness, nausea, constipation, and changes in blood pressure or heart rate. Serious side effects can include severe allergic reactions, breathing problems, and neuroleptic malignant syndrome[4].

  4. Are there generic alternatives to promethazine DM? Yes, generic versions of promethazine DM are available, which can reduce costs for patients[2].

  5. Can promethazine DM be used in combination with other medications? Promethazine DM may interact with certain medicines, so it is important to inform your healthcare provider about all prescription and over-the-counter medications you are using[4].

Cited Sources

  1. The Hope House - Promethazine Addiction: Understanding Promethazine Abuse
  2. SingleCare - How much is promethazine dm without insurance?
  3. ACCP - Scientific Abstracts (not directly cited but referenced for broader context)
  4. WebMD - Promethazine/Dextromethorphan - Uses, Side Effects, and More
  5. Drugs.com - Promethazine DM Alternatives Compared

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