OBREDON Drug Patent Profile

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

Obredon is a drug marketed by Sovereign Pharms and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in OBREDON is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Obredon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OBREDON

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4
What excipients (inactive ingredients) are in OBREDON?	OBREDON excipients list
DailyMed Link:	OBREDON at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OBREDON

Constraining patent/regulatory exclusivity:

9,549,907

NDA:

205474

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for OBREDON

Drug Class	Expectorant Opioid Agonist
Mechanism of Action	Opioid Agonists
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions

US Patents and Regulatory Information for OBREDON

OBREDON is protected by three US patents.

This potential generic entry date is based on patent 9,549,907.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No	9,549,907		Y	Y
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No	9,808,431		Y	Y
Sovereign Pharms	OBREDON	guaifenesin; hydrocodone bitartrate	SOLUTION;ORAL	205474-001	Nov 14, 2014		DISCN	Yes	No	10,105,324		Y	Y

OBREDON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Dextromethorphan (DXM)

Introduction

Dextromethorphan (DXM) is a widely used cough suppressant found in many over-the-counter (OTC) medications. Understanding the market dynamics and financial trajectory of DXM, particularly in the context of a potential switch from OTC to prescription-only, is crucial for stakeholders including manufacturers, pharmacies, physicians, and payors.

Current Market Status of DXM

DXM is currently available as an OTC medication, making it easily accessible to consumers. This widespread availability contributes to its high demand and revenue for manufacturers and pharmacies.

Impact of an OTC-to-Prescription-Only Conversion

Demand and Sales

A conversion from OTC to prescription-only would significantly impact the demand and sales of DXM. Economic theory suggests that higher prices and limited availability accompanying prescription access would lead to a decrease in demand. Some patients might opt for non-DXM OTC alternatives, while others might receive alternative prescription suggestions from their physicians or abandon cough medication altogether[1].

Retention of Sales

Studies based on the pseudoephedrine (PSE) experience indicate that such a conversion could result in a substantial drop in sales. For PSE, the conversion led to an 83% decrease in utilization and a 75% drop in sales, leaving only 17% to 25% of residual demand. Similar retention rates could be expected for DXM[1].

Financial Implications for Stakeholders

Manufacturers

The financial impact on manufacturers would depend on the volume and profit changes resulting from the regulatory change. While manufacturers might see a reduction in sales volume, the absence of detailed information on upstream costs makes it challenging to predict whether their margins would change[1].

Pharmacies

Pharmacies could benefit from dispensing fees in the prescription context but might lose revenue from reduced foot traffic and concurrent purchases. The net effect would depend on demand and price sensitivities[1].

Physicians

Physicians might see an increase in visits and revenue due to the need for prescriptions, but they could also face higher costs, including those associated with drug-seeking behavior by new patients[1].

Payors

Payors, including private and public health insurers, would likely implement cost-control mechanisms such as formularies, preferred drug lists, prior authorization, and quantity limits. These measures could affect the volume and profitability of DXM products through rebate requirements and other cost-control strategies[1].

Economic Analysis

Cost Implications

The conversion would subject DXM products to the cost-control mechanisms typically employed by payors. This could lead to higher costs for payors but lower out-of-pocket costs for patients, as long as the copay is less than the OTC cost of the therapy and the payor provides at least partial coverage[1].

Market Adjustments

The market would adjust to the new regulatory environment through various mechanisms. For instance, the number of OTC DXM packages purchased would need to be converted into a potential prescription count, reflecting the expected drop in demand due to higher prices and restricted access[1].

Case Study: Pseudoephedrine (PSE) Experience

The PSE experience provides valuable insights into the potential impact of an OTC-to-prescription-only conversion. The conversion of PSE resulted in a significant decrease in utilization and sales, highlighting the importance of considering demand and price sensitivities in such regulatory changes[1].

Industry Expert Insights

Industry experts emphasize the need for comprehensive analysis when considering regulatory changes. For example, economic models must account for dynamic effects such as changes in demand, price sensitivities, and the impact of cost-control mechanisms by payors[1].

Statistics and Trends

• From 2012 to 2021, the number of prescriptions for stimulant medications, which include some cough suppressants, increased by 45%, indicating a growing demand for prescription medications. However, this trend may not directly apply to DXM but highlights the broader pharmaceutical market dynamics[4].

Key Takeaways

• An OTC-to-prescription-only conversion for DXM would likely result in a significant decrease in demand and sales.
• Stakeholders, including manufacturers, pharmacies, physicians, and payors, would face various financial implications.
• The market would adjust through cost-control mechanisms and changes in consumer behavior.
• Historical data from similar conversions, such as the PSE experience, provide valuable insights into potential outcomes.

FAQs

Q: What would be the immediate impact on demand if DXM were converted from OTC to prescription-only? A: The demand for DXM would likely decrease due to higher prices and limited availability, with some patients opting for alternative OTC medications or abandoning cough medication altogether.

Q: How would pharmacies be affected by an OTC-to-prescription-only conversion of DXM? A: Pharmacies might benefit from dispensing fees but could lose revenue from reduced foot traffic and concurrent purchases.

Q: What cost-control mechanisms might payors implement if DXM were converted to prescription-only? A: Payors could implement formularies, preferred drug lists, prior authorization, and quantity limits to control costs.

Q: What historical data supports the potential impact of an OTC-to-prescription-only conversion for DXM? A: The pseudoephedrine (PSE) experience, where a similar conversion resulted in an 83% decrease in utilization and a 75% drop in sales, provides valuable insights.

Q: How would the financial trajectory of manufacturers be affected by such a conversion? A: The financial impact on manufacturers would depend on the volume and profit changes resulting from the regulatory change, though detailed information on upstream costs is necessary for precise predictions.

Sources

1. Managing Access to Dextromethorphan: Cost Implications of a Potential Over-the-Counter to Prescription-Only Conversion - Charles River Associates
2. Álvaro Obregón | Mexican Revolutionary & President - Britannica
3. Annual Report 2023 - ArcelorMittal
4. IQVIA Report on Stimulant Trends from 2012-2021 - US Department of Justice
5. VITA/TCE Volunteer Resource Guide - IRS