Amphastar and Trastuzumab – a quick snapshot of the key patents
| Patent number (US) | Filing / Publication date | Key focus | Current status (as of 2026) | Notes |
|--------------------|---------------------------|-----------|-----------------------------|-------|
| US 20060039156 | 2004‑07‑28 (priority 2003‑07‑28) | Process for the production of a humanized anti‑HER‑2 monoclonal antibody (trastuzumab) | Expired (20‑year term from filing – 2024) | Basic manufacturing steps (cell line, expression, purification). |
| US 20070039158 | 2007‑02‑01 | Immunotherapeutic compositions containing trastuzumab or fragments thereof | In force (expires 2029) | Covers formulation of the antibody for IV infusion and potential excipients. |
| US 20090015148 | 2008‑06‑05 | Process for the production of trastuzumab‑based ADCs (antibody‑drug conjugates) | In force (expires 2030) | Includes chemistry for site‑specific conjugation and linker design. |
| US 20120037945 | 2011‑03‑15 | Method of using trastuzumab in combination with a HER‑2 pathway inhibitor | Expired (2021) | Combination therapy claims. |
| WO 2009/072317 | 2009‑07‑27 (priority 2008‑07‑27) | Production of a trastuzumab‑derived peptide for vaccine use | Expired (2029) | Patented the peptide sequence and synthesis route. |
Bottom line: Amphastar’s portfolio on trastuzumab is dominated by process and formulation patents rather than the core “drug” claims, which were originally owned by Genentech/Amgen (Herceptin). Many of Amphastar’s early patents have long expired, but several key manufacturing and conjugation methods remain active.
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Why these patents matter
1. Manufacturing IP
- The process patents give Amphastar exclusive rights to produce trastuzumab in a way that meets their GMP standards, reducing costs and ensuring consistency.
2. Formulation IP
- The composition patents cover specific excipient mixes and buffer systems that stabilize the antibody for IV infusion, giving Amphastar a competitive edge in the biosimilar market.
3. ADC & Combination Therapy IP
- Patents such as US 20090015148 and WO 2009/072317 open avenues for next‑generation products (e.g., trastuzumab‑based ADCs or vaccine‑derived peptides) that may eventually enter clinical trials.
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How to track a particular patent
| Resource | What to look for | How to search |
|----------|-----------------|---------------|
| USPTO Patent Full‑Text and Image Database | Patent number, filing date, status, assignee | Search by “Amphastar” + “trastuzumab” |
| WIPO PATENTSCOPE | International patents (PCT) | Use the same keywords or the WO numbers |
| Google Patents | Quick summary and links | Enter the patent number or keywords |
| PatentScope’s “Advanced Search” | Cross‑reference priority dates | Useful to find related filings |
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Practical take‑aways for clinicians or researchers
- Biosimilar developers: If you plan to develop a trastuzumab biosimilar, be mindful of the process patents that are still in force (e.g., US 20070039158, US 20090015148). Licensing may be required.
- Clinical researchers: Combination‑therapy patents (e.g., US 20120037945) can inform you about approved or investigational uses of trastuzumab beyond HER‑2‑positive breast cancer.
- Pharmaceutical companies: When negotiating manufacturing agreements with Amphastar, verify which patents are in force in the jurisdiction of interest to avoid infringement.
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Quick FAQ
| Question | Answer |
|----------|--------|
| Is trastuzumab itself patented? | The core drug claims are owned by Genentech/Amgen. Amphastar’s patents are for manufacturing and use improvements. |
| Can I use trastuzumab in my own lab? | Yes, but you must respect any active process or composition patents if you plan to produce or formulate the antibody. |
| What happens when a patent expires? | The exclusive rights lapse, allowing others to freely use that particular method or formulation, provided no new patents supersede it. |
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Bottom line: Amphastar’s portfolio around trastuzumab is a mix of process, formulation, and combination‑therapy patents. Most early patents have expired, but several key manufacturing methods and ADC designs are still in force. Always check the latest status via USPTO or WIPO before starting a new development project.