Generic Vraylar Availability |
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Generic Vraylar Availability
Last updated on Jun 12, 2024. Vraylar is a brand name of cariprazine, approved by the FDA in the following formulation(s): VRAYLAR (cariprazine hydrochloride - capsule;oral) Manufacturer: ABBVIE Approval date: September 17, 2015 Strength(s): EQ 1.5MG BASE [RLD], EQ 3MG BASE [RLD], EQ 4.5MG BASE [RLD], EQ 6MG BASE [RLD] Has a generic version of Vraylar been approved?No. There is currently no therapeutically equivalent version of Vraylar available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vraylar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication. See also: Generic Drug FAQ. Related patentsPatents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. Patent 7,737,142Patent expiration dates: September 17, 2029✓ Patent use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE✓ Drug substance✓ Drug product September 17, 2029✓ Patent use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE✓ Drug substance✓ Drug product September 17, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE✓ Drug substance✓ Drug product September 17, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE✓ Drug substance✓ Drug product September 17, 2029✓ Patent use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER✓ Drug substance✓ Drug product Patent 7,943,621Patent expiration dates: December 16, 2028✓ Drug substance✓ Drug product Pharmaceutical formulations containing dopamine receptor ligandsPatent RE47350Issued: April 16, 2019Inventor(s): Sarkar Ranajoy & Dedhiya Mahendra G. & Chhettry AnilAssignee(s): Richter Gedeon Nyrt.The present invention relates to stable and bioavailable immediate release formulations comprising dopamine receptor ligands. Methods of treating various disorders by administering the formulations are also described. Patent expiration dates: July 16, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE July 16, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE July 16, 2029✓ Patent use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER July 16, 2029✓ Patent use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE July 16, 2029✓ Patent use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE Patent RE49110Patent expiration dates: July 16, 2029✓ Patent use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE July 16, 2029✓ Patent use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE July 16, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE July 16, 2029✓ Patent use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER Patent RE49302Patent expiration dates: July 16, 2029✓ Patent use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE July 16, 2029✓ Patent use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER July 16, 2029✓ Patent use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE July 16, 2029✓ Patent use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE Related exclusivitiesExclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. Exclusivity expiration dates: December 16, 2025 - ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS More about Vraylar (cariprazine) Check interactions Compare alternatives Pricing & coupons Reviews (478) Drug images Side effects Dosage information Patient tips During pregnancy Support group FDA approval history Drug class: atypical antipsychotics Breastfeeding En español Patient resources Vraylar drug information Professional resources Vraylar prescribing information Cariprazine (AHFS Monograph) Related treatment guides Bipolar Disorder Major Depressive Disorder Schizophrenia Glossary Term Definition Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Further informationAlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Medical Disclaimer |
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