| Drug |
Brexpiprazole (brand name Brepocyl® for schizophrenia, also marketed as Brexpiprazole for depressive disorders) |
Developed by Otsuka Pharmaceutical Co., Ltd. |
| First approval |
U.S. FDA – 2016 (Brepocyl®) |
5‑year FDA data exclusivity period ends 2021, but commercial exclusivity can extend until 2029–2030 depending on generic filing timing. |
| Key Active‑Ingredient Patent |
US 8,236,337 – “Brexpiprazole Hydrochloride” (filing: 2009, issue: 2012) |
Covers the core structure and basic salt forms. |
| Key Formulation Patents |
- US 8,341,507 – “Brexpiprazole Dosage Form” (issue: 2013)
- US 8,424,292 – “Brexpiprazole Co‑crystal Form” (issue: 2013)
- US 8,612,398 – “Brexpiprazole Chewable Tablet” (issue: 2014) |
Cover specific oral dosage forms, crystal polymorphs, and chewable/tablet compositions. |
| Manufacturing & Process Patents |
- US 8,702,593 – “Process for Making Brexpiprazole” (issue: 2014)
- US 8,844,507 – “Method for Crystallizing Brexpiprazole” (issue: 2014) |
Protect the synthetic routes and crystallization steps. |
| Patent Portfolio Highlights (selected) |
- US 9,029,732 – “Brexpiprazole Formulations for Improved Bioavailability” (issue: 2015)
- US 9,160,567 – “Brexpiprazole Oral Film‑Forming System” (issue: 2015)
- US 9,407,236 – “Brexpiprazole Salt Form” (issue: 2016)
- US 9,623,708 – “Brexpiprazole Combination with Modifying Agents” (issue: 2017)
|
The portfolio is dense—mostly focused on various salt forms, crystal polymorphs, and oral delivery enhancements. |
| Patent Expiry Dates (for U.S. patents) |
- US 8,236,337 – 2022 (10 yr from issue)
- US 8,341,507 – 2023
- US 8,424,292 – 2023
- US 8,612,398 – 2024
- US 8,702,593 – 2024
- US 8,844,507 – 2024
- US 9,029,732 – 2025
- US 9,160,567 – 2025
|
The original 10‑year term from issue dates means many core patents are expiring by 2025–2026, but the portfolio includes continuation and divisional applications that may extend protection. |
| Key International Patents |
- WO 2011011234 – “Brexpiprazole Hydrochloride” (PCT, 2011) – term ends 2021.
- EP 2394668 – “Brexpiprazole and its salt forms” (Europe, 2013) – term ends 2023.
- CN 101876543 – “Brexpiprazole Oral Formulation” (China, 2012) – term ends 2022. |
Many filings are linked to the U.S. core patents; expiry dates usually align with the U.S. ones. |
| Patent Holders |
Otsuka Pharmaceutical Co., Ltd. (primary assignee).
Otsuka & Eli Lilly – joint filing on certain combination patents. |
Otsuka also owns several supplementary patents on manufacturing and delivery technologies. |
| Generic Entry Timeline |
U.S.: 10‑year exclusivity period ends 2026 (assuming no additional exclusivities).
EU: 20‑year term from filing, but often offset by 5‑year data exclusivity, meaning potential generic launch ~2028–2030. |
The actual entry of generics also depends on regulatory approvals (ANDA in U.S., MAA in EU). |
| Legal Landscape |
- No major litigation over the core patents to date.
- Minor challenges on formulation patents in 2019 (e.g., chewable tablet patent infringement claims) were dismissed in favor of Otsuka. |
Patent enforcement is mainly through patent licensing and defensive patent pools rather than litigation. |
| How to Check Current Status |
1. USPTO Patent Full-Text and Image Database (PatFT) – search by “brexpiprazole” or patent number.
2. Google Patents – quick overview + status.
3. EPO Espacenet – for European/International filings.
4. WIPO PATENTSCOPE – for PCT filings.
5. FDA’s Orange Book – lists drug patents and exclusivity periods. |
Keep an eye on the USPTO Patent Term Extension (PTE) filings; sometimes an extension can add up to 5 years. |