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VRAYLAR Drug Profile
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» See Plans and PricingWhen do Vraylar patents expire, and when can generic versions of Vraylar launch?
Vraylar is a drug marketed by Allergan and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and nineteen patent family members in forty-two 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.
US ANDA Litigation and Generic Entry Outlook for Vraylar
Vraylar was eligible for patent challenges on September 17, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 17, 2029. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for VRAYLAR
| International Patents: | 119 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 2 |
| Patent Applications: | 18 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VRAYLAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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, LLC, an Allergan Affiliate | Phase 3 |
| Forest Laboratories | Phase 3 |
Recent Litigation for VRAYLAR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Allergan USA, Inc. v. Sun Pharmaceutical Industries Limited | 2019-12-20 |
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 |
| 3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea;hydrochloride |
| A15036 |
| 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 |
| 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 |
| Q27162922 |
| RGH-188 HCL |
| RGH-188 hydrochloride |
| RGH188 hydrochloride |
| s5849 |
| 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) |
Paragraph IV (Patent) Challenges for VRAYLAR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VRAYLAR | CAPSULE;ORAL | cariprazine hydrochloride | 204370 | 2019-09-17 |
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 | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Allergan | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-001 | Sep 17, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 |
|---|---|---|
| European Patent Office | 2317852 | Start Trial |
| Cyprus | 1113099 | Start Trial |
| Cyprus | 1119076 | Start Trial |
| Taiwan | 200505874 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VRAYLAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663996 | 1790042-4 | Sweden | Start Trial | PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717 |
| 1663996 | 2017C/045 | Belgium | Start Trial | PRODUCT NAME: CARIPRAZINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL, Y COMPRIS L'HYDROCHLORURE DE CARIPRAZINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717 |
| 1663996 | LUC00039 | Luxembourg | Start Trial | PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717 |
| 1663996 | 17C0008 | France | Start Trial | PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
