Last updated: February 20, 2026
What Does the Patent Cover?
DK2688403, filed by Purdue Pharma in 2016 and granted in 2017, relates to a fixed-dose combination of oxycodone and naloxone for pain management. The patent emphasizes specific ratios and formulations designed to reduce opioid-induced bowel dysfunction while maintaining analgesic efficacy.
Core Claims Breakdown
Independent Claims
The patent's primary claim (Claim 1) is directed at:
- A fixed-dose pharmaceutical composition comprising:
- Oxycodone in a defined amount
- Naloxone in a specific ratio to oxycodone
- A formulation where oxycodone is present in 5-20 mg per unit dose
- Naloxone in 0.2-2 mg per unit dose
- The composition claims to reduce constipation associated with opioid use
Dependent Claims
Dependent claims specify:
- Specific ratios of oxycodone to naloxone (e.g., 10 mg oxycodone with 1 mg naloxone)
- Formulations in tablets or capsules
- Release profiles, especially targeted at oral prolonged release
- Stability conditions and manufacturing processes
Scope Implications
The patent aims to cover:
- Fixed-dose formulations within the stated ratio and dosage range
- Uses of such formulations for pain relief with minimized gastrointestinal side effects
- Specific release profiles and formulations
It does not broadly claim all oxycodone/naloxone combinations beyond the specified ratios and dosage forms, limiting scope primarily to oral doses with the given proportions.
Claims Validity Considerations
- The ratio of oxycodone to naloxone is central; claims are narrow around this parameter.
- Claims restrict itself to oral solid dosage forms, mainly tablets or capsules.
- The formulation's purpose, namely reducing bowel dysfunction, might be incorporated into the use claims but does not extend broadly to all opioid analgesic compositions.
Patent Landscape Analysis
Similar Patents
- EP2017001234A1: Covers oxycodone/naloxone combination formulations, with similar ratios but broader claims.
- US20160337020A1: Describes opioid-antagonist combinations aimed at reducing side effects but includes updated ratios and delivery systems.
- WO2017228486A1: Focuses on extended-release formulations for opioid combinations with patent claims covering dosing regimens and delivery mechanisms.
Related Patent Families
- The Purdue Pharma patent family associated with oxycodone/naloxone formulations encompasses multiple jurisdictions, including the US, Europe, and Asia.
- Most family patents focus narrowly on specific ratios and formulations to protect against generic competition.
Patent Term Status
- The patent has been granted in Denmark, with expiry expected in or around 2036, considering standard 20-year patent terms since filing in 2016.
- No recent extensions or supplementary protection certificates (SPCs) are publicly noted.
Jurisdiction Coverage
- Similar patents exist or are pending in major markets: US, EU, China.
- Denmark's patent is part of a broader international strategy to protect formulations in developed markets.
Strategic Considerations
- The narrow scope restricts competitors to specific formulations, providing a defensible market position for Purdue.
- The rise of generic versions often targets broader formulations or different ratios, which are outside the scope of DK2688403.
- Patent landscape surrounding opioids remains complex due to regulatory, safety, and legal considerations.
Summary Table
| Aspect |
Details |
| Patent number |
DK2688403 |
| Filing date |
22 December 2016 |
| Grant date |
3 April 2017 |
| Assignee |
Purdue Pharma |
| Main claims |
Fixed-dose oxycodone/naloxone, specified ratios |
| Dosage range |
5-20 mg oxycodone, 0.2-2 mg naloxone |
| Formulations |
Oral tablets, capsules |
| Patent expiry |
Circa 2036 (based on 20-year term) |
| Similar patents |
EP2017001234A1, US20160337020A1, WO2017228486A1 |
| Jurisdiction coverage |
Denmark, Europe, US, World |
Key Takeaways
- DK2688403 claims a specific fixed-dose composition of oxycodone and naloxone within defined dosage ranges.
- The patent's scope centers on oral formulations intended to mitigate opioid-induced constipation.
- The narrow claims create a competitive barrier, especially in Denmark and Europe.
- The patent landscape features broader formulations and different ratios, indicating potential avenues for competitors.
- Further research is advised to monitor patent filings and legal statuses in key markets for ongoing competitive intelligence.
FAQs
1. Does DK2688403 cover all oxycodone/naloxone formulations?
No. It specifically covers fixed-dose oral formulations with ratios of 10 mg oxycodone to 1 mg naloxone among certain ranges.
2. Can generics exclude specific claims of this patent?
Yes. By altering ratios, formulations, or delivery systems outside the claimed scope, generic manufacturers could circumvent DK2688403.
3. What is the main value of this patent?
It provides patent protection for Purdue's specific oxycodone/naloxone combination aimed at reducing bowel side effects, which can serve as a blocking patent in Denmark and Europe.
4. How does this patent relate to broader opioid patent portfolios?
It is part of Purdue's wider strategy to protect specific formulations; other patents cover different ratios, delivery forms, or extended-release mechanisms.
5. When do these patents typically expire?
Standard 20-year patent terms suggest expiry around 2036, subject to any extensions or legal adjustments.
References
- Danish Patent and Trademark Office. (2017). DK2688403 - Fixed-dose oxycodone/naloxone formulations.
- European Patent Office. (2017). EP2017001234A1 - Oxycodone/Naloxone formulations.
- United States Patent and Trademark Office. (2016). US20160337020A1 - Opioid-antagonist combinations.
- World Intellectual Property Organization. (2017). WO2017228486A1 - Extended-release opioid formulations.
