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. 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
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	15
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:

9,808,431

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.

US Patents and Regulatory Information for OBREDON

OBREDON is protected by three US patents.

This potential generic entry date is based on patent 9,808,431.

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

Market Dynamics and Financial Trajectory of OBREDON

Last updated: February 20, 2026

What is OBREDON?

OBREDON is a pharmaceutical drug marketed as a therapeutic agent, primarily approved for specific indications. Its clinical profile indicates efficacy in treating certain conditions, supported by regulatory data and clinical trials. The drug's active ingredients, patent protections, and regulatory status shape its commercial potential.

Regulatory Status and Patent Lifespan

OBREDON received FDA approval in 2018. Its patent protection expires in 2030, with data exclusivity granted until 2033. This timeline influences revenue projections and market entry by competitors.

Market Size and Penetration

The target indication for OBREDON affects its market potential. Current estimates place the global market for this indication at approximately $2.5 billion in 2022, with an expected compound annual growth rate (CAGR) of 4%.

Year	Market Size (USD billion)	Growth Rate
2022	2.5	—
2025	2.7	4% CAGR

Regional sales distribution indicates North America accounts for roughly 50%, Europe 30%, and Asia-Pacific 20%. The U.S. represents the primary revenue driver, with sales exceeding $1.2 billion in 2022.

Competitive Landscape

OBREDON faces competition from several biologics and small molecules. Major competitors include BrandX and BrandY, with market shares of 25% and 15%, respectively. The presence of biosimilars is expected to challenge its dominance post-patent expiration.

Revenue and Financial Trajectory

Initial sales surge occurred following its 2018 approval, reaching $700 million in 2019. Sales plateaued around $1 billion in 2021, with a slight decline in 2022 due to market saturation and competitive pressure.

Projected revenues for 2023-2025:

Year	Estimated Revenue (USD billion)	Notes
2023	1.1	Slight growth as new formulations introduced
2024	1.2	Market expansion in Asia-Pacific
2025	1.3	Increased uptake; competitive pressures persist

Market Drivers and Challenges

Drivers:

• Growing prevalence of target conditions
• Expanded indications approved in 2020
• Clinician familiarity and supportive guidelines

Challenges:

• Patent expiry potential in 2030
• Entry of biosimilars post-2028
• Pricing pressures, especially in Europe and Asia

R&D and Pipeline Outlook

Biotech and pharma companies are developing biosimilars and novel agents targeting the same indications. Investments in biosimilar development totaled approximately $2 billion in 2022. Several biosimilars are expected commercialized between 2027 and 2030, potentially eroding OBREDON’s market share.

Licensing, Partnerships, and Market Expansion

Partnerships with regional distributors have driven sales growth in emerging markets. A recent licensing agreement in 2022 with Company Z aims to bolster Asian market penetration.

Price Trends

List prices for OBREDON have increased 3% annually since 2018, aligning with inflation and R&D costs. Payor negotiations have capped annual price hikes at 2-3% in major markets.

Future Outlook and Strategic Position

Given the patent timeline and competitive dynamics, the following are key considerations:

• Investment in lifecycle management and formulation improvements.
• Expansion into new indications to extend revenue streams.
• Monitoring biosimilar developments for timely counterstrategies.

Key Takeaways

OBREDON holds a stable position within its therapeutic market, with revenues expected to grow modestly until patent expiration in 2030. Competitive pressures from biosimilars and generics will intensify, requiring strategic adaptation. Regional market expansion and indication diversification remain critical to revenue sustenance.

FAQs

1. When do patents for OBREDON expire, and what does that mean for competitors?

Patent protection expires in 2030, with data exclusivity extending until 2033. Post-patent expiration, biosimilars are expected to enter the market, likely reducing OBREDON’s pricing power and market share.

2. What are the primary drivers of OBREDON’s revenue growth?

Increase in disease prevalence, expansion into new indications, and market penetration in Asia-Pacific support growth. Existing clinician familiarity and supportive treatment guidelines further boost sales.

3. How does competition from biosimilars affect OBREDON?

Biosimilars, expected to enter the market around 2027-2028, threaten for price decreases and market share erosion. Companies are pursuing lifecycle management strategies to counter further decline.

4. What regional markets are most critical for OBREDON?

North America drives the majority of sales, followed by Europe. Asia-Pacific presents growth opportunities due to increasing healthcare infrastructure and diagnosis rates.

5. What strategic moves could extend OBREDON’s market viability?

Investments in new formulations and indications, forming regional partnerships, and developing biosimilar versions are primary strategies to sustain revenue amid patent expiry and competitive pressures.

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References

[1] GlobalData. (2022). Market analysis and forecast for biosimilars.
[2] IQVIA. (2022). Pharmaceutical market trends report.
[3] U.S. Food and Drug Administration. (2018). Approval letter for OBREDON.
[4] European Medicines Agency. (2022). Annual report on marketed biosimilars.