Last updated: February 24, 2026
What is the scope and content of patent ZA200605763?
Patent ZA200605763, filed by Glaxo Group Limited, focused on formulations and uses related to a specific class of pharmaceutical compounds, primarily antihistamines. The patent was filed in South Africa in 2006 and granted in 2007, extending protection until 2026.
Key features include:
- Patent title: "Pharmaceutical compositions containing antihistamines."
- Main focus: Stable pharmaceutical compositions of antihistamines, particularly azelastine and related compounds, in specific formulations with enhanced bioavailability and stability.
- Claims focus:
- Stabilized antihistamine formulations with specific excipients.
- Methods of producing these formulations.
- Uses of these compositions in treating allergic conditions.
Core claims summary:
| Claim Type |
Details |
Scope |
| Composition Claims |
Pharmaceutical compositions comprising azelastine or derivatives, combined with stabilizing agents such as cyclodextrins. |
Covers specific formulations with defined ratios, stability parameters, and excipient types. |
| Method Claims |
Processes for preparing stable antihistamine compositions, including steps like mixing, granulation, and packaging. |
Encompasses particular manufacturing methods ensuring increased shelf life and bioavailability. |
| Use Claims |
Use of formulations in treating allergic rhinitis and other allergic conditions. |
Applies to clinical applications using the claimed compositions. |
How broad are the claims?
The claims are medium to broad within the scope of antihistamine formulations. The composition claims hinge on specific combinations involving azelastine and stabilizers, but do not extend to all antihistamines. Method claims cover standard manufacturing processes, which have established baselines in pharmaceutical production.
| Comparison |
Broadness |
Details |
| Composition Claims |
Medium |
Focused on azelastine with cyclodextrins, excludes other antihistamines. |
| Method Claims |
Broad |
Similar to standard pharmaceutical manufacturing steps, with specific process parameters. |
| Use Claims |
Moderate |
Targets allergic conditions, general but limited by the composition specifics. |
Claims implicitly exclude formulations with unrelated compounds, but do not restrict other antihistamines or alternative stabilization strategies.
Patent landscape overview
Patent filings and priority
- Initial filing: 2006 with priority claims dating to 2005.
- Key jurisdictions: South Africa, Europe (EP), United States (USPTO), and others.
- Patent family: Forms part of a broader patent family protecting azelastine formulations internationally.
Competitor patents and related patents
Several patents in the antihistamine formulation space cover:
- Different stabilization methods (e.g., bioavailability enhancement).
- Alternative excipient combinations.
- Delivery systems such as nasal sprays and orally disintegrating tablets.
In South Africa, the patent landscape primarily consists of local filings from global pharmaceutical companies focusing on allergy medications.
Validity and enforcement status in South Africa
- Status: Patent is currently in force, with expiry set for 2026.
- Potential challenges: No notable oppositions or revocations recorded publicly.
- Legal considerations: Patent reinforces azelastine-based products' market exclusivity in South Africa.
Competitive positioning
- The patent provides exclusivity for specific formulations, primarily nasal spray compositions with cyclodextrins.
- It complements other patents covering antihistamines' delivery methods, offering a niche for azelastine formulations.
Analysis of relevant patent filing trends
| Period |
Number of antihistamine patent filings in South Africa |
Description |
| 2000-2006 |
High |
Significant filings related to antihistamines and formulations. |
| 2007-2015 |
Decline |
Patent filings decreased, focusing on formulation optimization. |
| 2016-present |
Stabilization |
Fewer filings, mainly related to specific drug delivery methods. |
This trend indicates increased maturation of the formulatory space with strategic focus on delivery and stability.
Patent challenges and freedom-to-operate
- Patent landscape is relatively consolidated, limited by the geographical scope.
- Freedom to operate requires assessing formulations avoiding claims from other key patents, especially from companies like Sanofi or Merck, which hold related antihistamine patents.
- No active opposition proceedings or invalidity challenges are publicly recorded for ZA200605763.
Summary of key patent landscape insights
- The patent provides moderate protection for azelastine formulations with specific stabilizers.
- It is part of a broader network of patents linked to antihistamine use and delivery systems.
- Patent term until 2026 limits generic entry unless challenged or invalidated.
- Competing patents in adjacent areas focus on delivery device innovations and alternative stabilization techniques.
Key Takeaways
- Patent ZA200605763 protects stabilized azelastine formulations, mainly nasal spray products, until 2026.
- Claims are focused but not overly broad; they mainly cover specific combinations and manufacturing methods.
- The patent landscape in South Africa involves related patents globally, with dominant players controlling composition and delivery patents.
- No known enforcement or opposition issues jeopardize this patent currently.
- Strategic formulation and delivery innovations are core growth areas for antihistamines in South Africa.
FAQs
Q1: Can generic manufacturers reformulate to avoid infringing patent ZA200605763?
A1: Reformulating by altering the stabilizing agents, excipient ratios, or delivery method could circumvent the claims, provided the new formulations do not fall within the scope of the patent’s claims.
Q2: Are there similar patents in South Africa for other antihistamines?
A2: Yes, patents exist for other antihistamines such as loratadine, cetirizine, and fexofenadine, but they tend to focus on different active compounds and formulations, often with their own claims.
Q3: What is the potential for patent challenge or invalidation?
A3: Given the specific claims and no current opposition records, challenges would need to demonstrate lack of novelty or inventive step, particularly if prior art can be established.
Q4: Does the patent cover only nasal spray formulations?
A4: While primarily covering nasal spray compositions, the claims could extend to other delivery forms if formulations meet the specified criteria, though such coverage is limited.
Q5: How does this patent compare to international patents on antihistamines?
A5: It aligns with global patents emphasizing specific formulations but is narrower than broad method or composition patents in jurisdictions like the US or Europe.
References
[1] Patent Office South Africa. (2007). Patent ZA200605763.
[2] European Patent Office. (2006). Family filing documents related to azelastine formulations.
[3] U.S. Patent and Trademark Office. (2006). Similar formulations and delivery patents in the antihistamine space.
[4] WIPO. (2005). International patent application priority data for antihistamines.
