DrugPatentWatch Database Preview
VRAYLAR Drug Profile
When do Vraylar patents expire, and what generic alternatives are available?
Vraylar is a drug marketed by Allergan Sales Llc and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and sixteen patent family members in forty-one countries.
The generic ingredient in VRAYLAR 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.
Summary for VRAYLAR
| International Patents: | 116 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 25 |
| Clinical Trials: | 2 |
| Patent Applications: | 18 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VRAYLAR |
| DailyMed Link: | VRAYLAR at DailyMed |
Generic Entry Opportunity Date for VRAYLAR
Generic Entry Date for VRAYLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VRAYLAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Forest Laboratories | Phase 3 |
| Forest Laboratories, LLC, an Allergan Affiliate | Phase 3 |
Pharmacology for VRAYLAR
| Drug Class | Atypical Antipsychotic |
Synonyms for VRAYLAR
| 1083076-69-0 |
| 3-((1R,4r)-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea hydrochloride |
| AKOS027338713 |
| BCP24194 |
| Cariprazine (hydrochloride) |
| Cariprazine HCl |
| CARIPRAZINE HYDROCHLORIDE |
| Cariprazine hydrochloride (JAN/USAN) |
| Cariprazine hydrochloride [USAN] |
| cariprazine monohydrochloride |
| cariprazine.HCl |
| CHEBI:90932 |
| CHEMBL2024517 |
| CS-1570 |
| D09876 |
| EX-A1644 |
| FT-0701196 |
| HY-14763A |
| KQD7C255YG |
| KS-00000640 |
| MolPort-044-723-876 |
| N'-(Trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-N,N-dimthylurea monohydrochloride |
| N'-(trans-4-{2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl}cyclohexyl)-N,N-dimethylurea hydrochloride |
| RGH-188 HCL |
| RGH-188 hydrochloride |
| SB16840 |
| SCHEMBL183803 |
| SCHEMBL183804 |
| UNII-KQD7C255YG |
| Urea, N'-(trans-4-(2-(4-(2,3-dichlorophenyl)-1-piperazinyl)ethyl)cyclohexyl)-N,N- dimethyl-, hydrochloride (1:1) |
| Vraylar (TN) |
US Patents and Regulatory Information for VRAYLAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan Sales Llc | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Allergan Sales Llc | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| Allergan Sales Llc | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VRAYLAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Serbia | 56036 | See Pricing |
| South Korea | 100870284 | See Pricing |
| European Patent Office | 2317852 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VRAYLAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663996 | 122017000083 | Germany | See Pricing | PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713 |
| 1663996 | PA2017027,C1663996 | Lithuania | See Pricing | PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713 |
| 1663996 | C 2017 040 | Romania | See Pricing | PRODUCT NAME: CARIPRAZINA, OPTIONAL SUB FORMA UNEI SARI A ACESTEIA, INCLUZAND CARIPRAZINA CLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF NATIONAL AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
