CARIPRAZINE HYDROCHLORIDE Drug Patent Profile
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When do Cariprazine Hydrochloride patents expire, and what generic alternatives are available?
Cariprazine Hydrochloride is a drug marketed by Sun Pharm and Zydus and is included in two NDAs.
The generic ingredient in CARIPRAZINE HYDROCHLORIDE is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
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Summary for CARIPRAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 41 |
| Patent Applications: | 57 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CARIPRAZINE HYDROCHLORIDE |
| DailyMed Link: | CARIPRAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for CARIPRAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AbbVie | Phase 4 |
| The Medical Research Network | Phase 4 |
| AbbVie | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for CARIPRAZINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CARIPRAZINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VRAYLAR | Capsules | cariprazine hydrochloride | 1.5 mg, 3 mg, 4.5 mg and 6 mg | 204370 | 3 | 2019-09-17 |
US Patents and Regulatory Information for CARIPRAZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | CARIPRAZINE HYDROCHLORIDE | cariprazine hydrochloride | CAPSULE;ORAL | 213932-001 | Sep 30, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus | CARIPRAZINE HYDROCHLORIDE | cariprazine hydrochloride | CAPSULE;ORAL | 213984-003 | Sep 9, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | CARIPRAZINE HYDROCHLORIDE | cariprazine hydrochloride | CAPSULE;ORAL | 213932-004 | Sep 30, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus | CARIPRAZINE HYDROCHLORIDE | cariprazine hydrochloride | CAPSULE;ORAL | 213984-004 | Sep 9, 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 |
