Opipza Patent Expiration

Opipza is a drug owned by Xiamen Lp Pharmacuetical Co Ltd. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 15, 2041. Details of Opipza's patents and their expiration are given in the table below.

Filter patents by

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11701352 Process for preparing aripiprazole oral soluble film
Dec, 2041

(16 years from now)

Active
US11331315 Aripiprazole oral soluble film
Nov, 2040

(15 years from now)

Active

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US patents provide insights into the exclusivity only within the United States, but Opipza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Opipza's family patents as well as insights into ongoing legal events on those patents.

Opipza's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Opipza:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Opipza(Aripiprazole) has 2 clinical trials that have been verified in 2024. Out of these 2, 1 trial is in PHASE4.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Aripiprazole in Body Focused Repetitive Behaviors University of Chicago NA NOT YET RECRUITING
(Jul, 2024)
PHASE2
VA Aripiprazole vs Esketamine for Treatment Resistant Depression VA Office of Research and Development NA WITHDRAWN
(Jan, 2024)
PHASE4
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia Otsuka Pharmaceutical Europe Ltd H. Lundbeck A/S UNKNOWN
(Apr, 2019)
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders Indiana University National Institute of Mental Health (NIMH), Bristol-Myers Squibb COMPLETED
(Mar, 2018)
PHASE3
Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI University of British Columbia Bristol-Myers Squibb COMPLETED
(May, 2016)
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. Otsuka Pharmaceutical Development & Commercialization, Inc. NA TERMINATED
(Jan, 2016)
PHASE3
Aripiprazole for the Augmentation of Antidepressant Therapy Taiwan Otsuka Pharm. Co., Ltd NA COMPLETED
(May, 2014)
PHASE4
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Feb, 2013)
PHASE3
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Aug, 2008)
PHASE4
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Sep, 2007)
PHASE2, PHASE3




Generic Launch

Generic Release Date:

Opipza's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 15, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Opipza Generic API suppliers:

Aripiprazole is the generic name for the brand Opipza. 28 different companies have already filed for the generic of Opipza, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Opipza's generic

Alternative Brands for Opipza

There are several other brand drugs using the same active ingredient (Aripiprazole) as Opipza. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.


Apart from brand drugs containing the same ingredient, some generics have also been filed for Aripiprazole, Opipza's active ingredient. Check the complete list of approved generic manufacturers for Opipza





About Opipza

Opipza is a drug owned by Xiamen Lp Pharmacuetical Co Ltd. Opipza uses Aripiprazole as an active ingredient. Opipza was launched by Xiamen Lp Pharm Co in 2024.

Approval Date:

Opipza was approved by FDA for market use on 22 July, 2024.

Active Ingredient:

Opipza uses Aripiprazole as the active ingredient. Check out other Drugs and Companies using Aripiprazole ingredient

Dosage:

Opipza is available in film form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2MG FILM Prescription ORAL
10MG FILM Prescription ORAL
5MG FILM Prescription ORAL