BREXPIPRAZOLE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Brexpiprazole, and when can generic versions of Brexpiprazole launch?
Brexpiprazole is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Optimus, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms. and is included in ten NDAs.
The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Brexpiprazole
A generic version of BREXPIPRAZOLE was approved as brexpiprazole by OPTIMUS on October 25th, 2023.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for BREXPIPRAZOLE?
- What are the global sales for BREXPIPRAZOLE?
- What is Average Wholesale Price for BREXPIPRAZOLE?
Summary for BREXPIPRAZOLE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 73 |
| Patent Applications: | 319 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BREXPIPRAZOLE |
| DailyMed Link: | BREXPIPRAZOLE at DailyMed |
Recent Clinical Trials for BREXPIPRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| H. Lundbeck A/S | Phase 4 |
| Iqvia Pty Ltd | Phase 1 |
| Queen's University | Phase 4 |
Pharmacology for BREXPIPRAZOLE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for BREXPIPRAZOLE
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| REXULTI | Tablets | brexpiprazole | 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg | 205422 | 18 | 2019-07-10 |
US Patents and Regulatory Information for BREXPIPRAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Optimus | BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213758-005 | Oct 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213512-002 | Mar 17, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa Inc | BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213692-001 | Aug 11, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for BREXPIPRAZOLE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Netherlands B.V. | Rxulti | brexpiprazole | EMEA/H/C/003841 Treatment of schizophrenia. |
Authorised | no | no | no | 2018-07-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
