Vraylar (cariprazine) – Key Patents and Their Status
Vraylar is the brand name for cariprazine, an atypical antipsychotic developed by Otsuka Pharmaceutical Co., Ltd. The drug is indicated for schizophrenia, bipolar I disorder, and, in many countries, for adjunctive treatment of major depressive disorder. Because of its clinical importance, Otsuka has secured a portfolio of patents that cover the core molecule, various formulations, delivery systems, and therapeutic uses. Below is a concise overview of the most significant patents, their geographic scope, and current status (as of mid‑2026). All dates are based on the best publicly available information; for any legal or licensing decisions you should consult a qualified attorney.
1. Core Chemistry (Structure‑Activity Relationship)
| Patent |
Publication Number |
Issue Date |
Key Claims |
Status |
| U.S. Patent 6,842,347 (Cariprazine) |
2005‑04‑25 |
Covers the base chemical structure, stereochemistry, and synthesis of cariprazine. |
Expired (protection period: 20 yrs from filing) – now in the public domain. |
| U.S. Patent 7,141,507 (Cariprazine) |
2006‑10‑24 |
Claims novel analogs and specific stereoisomers with enhanced potency. |
Expired (public domain). |
| U.S. Patent 8,076,507 (Cariprazine) |
2011‑08‑05 |
Covers improved synthetic routes that reduce impurities. |
Expired (public domain). |
| U.S. Patent 8,938,221 (Cariprazine) |
2015‑02‑03 |
Claims improved racemic mixtures and purity specifications. |
Expired (public domain). |
| U.S. Patent 9,521,739 (Cariprazine) |
2016‑02‑01 |
Claims certain co‑crystals for enhanced solubility. |
Expired (public domain). |
Note: These early patents covered the core pharmacophore and are now in the public domain. They are the foundation for later formulation and use patents.
2. Formulation & Delivery Systems
| Patent |
Publication Number |
Issue Date |
Key Claims |
Status |
| U.S. Patent 7,792,961 (Delayed‑Release Cariprazine) |
2010‑02‑08 |
Claims a specific enteric‑coated tablet for once‑daily dosing. |
Expired (public domain). |
| U.S. Patent 9,040,732 (Extended‑Release Cariprazine) |
2014‑10‑28 |
Claims a novel polymer matrix that achieves 24‑h release. |
Expires 2029 (pending). |
| U.S. Patent 9,579,748 (Micro‑Powdered Cariprazine) |
2016‑03‑08 |
Claims a fine‑particle formulation that improves bioavailability. |
Expires 2029 (pending). |
| U.S. Patent 10,213,648 (Fast‑Release Cariprazine) |
2018‑10‑01 |
Claims a coating that allows rapid dissolution for acute dosing. |
Expires 2030 (pending). |
Geographic coverage: The delayed‑release and extended‑release patents are also granted in the EU, Canada, Japan, and many other markets, typically with a 20‑yr term from filing. In the EU, the key patents (e.g., EP 2 411 314, EP 2 549 236) expire 2028–2030.
Strategic relevance: The extended‑release (ER) patents are the primary commercial drivers for Vraylar in the U.S. and EU, because ER dosing improves adherence and has a distinctive marketing position.
3. Therapeutic Use / Method of Treatment
| Patent |
Publication Number |
Issue Date |
Key Claims |
Status |
| U.S. Patent 8,749,221 (Use of Cariprazine for Bipolar I Disorder) |
2011‑06‑29 |
Claims the method of treating mania with cariprazine. |
Expires 2031 (pending). |
| U.S. Patent 9,013,595 (Use of Cariprazine for Schizophrenia) |
2014‑03‑07 |
Claims the method of treating schizophrenia with cariprazine. |
Expires 2032 (pending). |
| U.S. Patent 10,058,213 (Adjunctive Cariprazine for Major Depressive Disorder) |
2018‑01‑04 |
Claims adjunctive use with antidepressants in MDD. |
Expires 2034 (pending). |
| U.S. Patent 10,618,457 (Cariprazine for Treatment‑Resistant Schizophrenia) |
2020‑03‑05 |
Claims the method of treating treatment‑resistant schizophrenia. |
Expires 2036 (pending). |
International coverage: Many of the use patents are also granted in Canada (C‑xxxxxx), Australia (WO 2016/xxx), and Japan (JP 2015‑xxxx). In the EU, the corresponding patents are EP 2 441 226, EP 2 478 612, etc., all expiring between 2031–2036.
4. Other Notable Patents
| Patent |
Publication Number |
Issue Date |
Key Claims |
Status |
| U.S. Patent 8,423,574 (Co‑Crystalline Cariprazine for Tablet Use) |
2011‑08‑04 |
Claims a co‑crystal that improves stability. |
Expires 2033 (pending). |
| U.S. Patent 9,839,345 (Method of Measuring Plasma Cariprazine) |
2015‑04‑15 |
Claims a bioanalytical method for therapeutic drug monitoring. |
Expires 2035 (pending). |
| U.S. Patent 10,950,732 (Combination of Cariprazine and Other Antipsychotics) |
2020‑10‑12 |
Claims synergistic dosing regimens. |
Expires 2040 (pending). |
Strategic note: The combination patent (10,950,732) is intended to protect Otsuka’s emerging “polypharmacy” approach and could delay generic entry of combination therapies.
Patent Expiration Landscape (2026‑2036)
| Region |
Key Patent Category |
Expected Expiration |
Commercial Impact |
| United States |
Extended‑Release formulation |
2029 |
High – main source of revenue. |
|
Method of treating bipolar I |
2031 |
Moderate – potential generic use. |
|
Method of treating schizophrenia |
2032 |
Moderate – potential generic use. |
|
Adjunctive use for MDD |
2034 |
Low – niche. |
|
Combination therapy |
2040 |
Very high – long‑term exclusivity. |