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Last Updated: December 22, 2024

OZOBAX Drug Patent Profile


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When do Ozobax patents expire, and what generic alternatives are available?

Ozobax is a drug marketed by Metacel Pharms Llc and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in OZOBAX is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ozobax

A generic version of OZOBAX was approved as baclofen by IVAX SUB TEVA PHARMS on July 21st, 1988.

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Summary for OZOBAX
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 150
Patent Applications: 4,891
What excipients (inactive ingredients) are in OZOBAX?OZOBAX excipients list
DailyMed Link:OZOBAX at DailyMed
Drug patent expirations by year for OZOBAX
Pharmacology for OZOBAX

US Patents and Regulatory Information for OZOBAX

OZOBAX is protected by one US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metacel Pharms Llc OZOBAX baclofen SOLUTION;ORAL 208193-001 Sep 18, 2019 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Metacel Pharms Llc OZOBAX DS baclofen SOLUTION;ORAL 208193-002 Oct 12, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

OZOBAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OZOBAX (Baclofen)

Introduction to OZOBAX

OZOBAX, a brand name for the medication baclofen, is a muscle relaxant and central nervous system depressant used primarily to treat muscle spasticity. Here, we will delve into the market dynamics and financial trajectory of OZOBAX, highlighting its usage, market trends, and financial performance.

Market Trends and Usage

Increasing Prescriptions and Global Sales

Baclofen, the active ingredient in OZOBAX, has seen a significant rise in prescriptions over the years. From 2014 to 2016, the number of baclofen prescriptions increased from 4.76 million to 5.70 million, although it slightly decreased to 4.58 million in 2017[1].

Global Sales Projections

With the current trends in use, global sales of baclofen are projected to exceed $400 million by 2024. This growth indicates a strong market demand for the medication[1].

Forms and Brands of Baclofen

Available Forms

Baclofen is available in various forms, including oral tablets, liquid solutions, and an injectable form that is administered into the spinal cord by a medical professional[1].

Brand Names

In the US, baclofen is marketed under several brand names, including Lioresal, Kemstro, Ozobax, and Gablofen. However, Lioresal and Kemstro are no longer available, with generic versions being the primary options[1].

Abuse and Misuse

Euphoric Effects and Abuse

Baclofen can cause euphoria and calming effects, leading to its abuse. It is also used to reduce cravings in alcohol and heavy smoking, but some individuals misuse it for its euphoric effects or combine it with other prescription drugs like sleeping pills and antidepressants[1].

Statistics on Exposures

Between 2014 and 2017, US poison centers recorded 15,397 cases of baclofen exposures, with 8,185 cases being suicide attempts. This period saw a 36.2% increase in exposures and a 40.2% increase in suicide attempts involving baclofen[1].

Financial Performance of Related Pharmaceutical Companies

Allergan's Financial Results

While OZOBAX itself is not a major contributor to the overall financial results of large pharmaceutical companies, the broader context of the pharmaceutical industry can provide insights. For instance, Allergan, a major pharmaceutical company, reported significant financial results in 2019. Their U.S. Specialized Therapeutics segment saw net revenues of $1.82 billion in the fourth quarter of 2019, with a segment gross margin of 91.4%[3].

Segment Contributions

Allergan's financial performance is driven by various segments, including Facial Aesthetics, Central Nervous System treatments, and other therapeutic areas. However, the specific financial performance of OZOBAX is not highlighted in these reports, as it is a smaller part of the overall market[3].

Patient Savings and Support

Patient Savings Card

To make OZOBAX more accessible, patients can use the OZOBAX Patient Savings Card, which allows them to pay as little as $15 for a 30-day supply, with a reimbursement limit of $200 per month[2].

Generic Availability and Safety Concerns

Generic Versions

OZOBAX, being a brand name, has generic versions available. However, it is crucial to be cautious of fraudulent online pharmacies that may sell counterfeit generic versions of baclofen, which can be unsafe[4].

Safety Advice

Patients are advised to purchase medications only from reputable and valid online pharmacies and to consult their healthcare providers if they are unsure about any online purchase[4].

Market Dynamics and Competition

Market Growth Drivers

The growth in the baclofen market is driven by increasing prescriptions, the need for muscle spasticity treatment, and its use in managing alcohol and smoking cravings. However, the market also faces challenges such as misuse and the emergence of counterfeit drugs[1].

Competitive Landscape

The muscle relaxant market is competitive, with various brands and generic options available. OZOBAX competes with other baclofen brands and generic versions, making pricing and patient support programs critical for market share[1].

Regulatory Environment

FDA Approval

OZOBAX was approved by the FDA in 2019 for oral solution formulations, although these formulations have since been discontinued[4].

Regulatory Oversight

The FDA and other regulatory bodies play a crucial role in ensuring the safety and efficacy of medications like OZOBAX. This oversight helps in maintaining the integrity of the pharmaceutical market and protecting consumers from counterfeit drugs[4].

Future Outlook

Market Projections

Given the projected global sales exceeding $400 million by 2024, the future outlook for OZOBAX and baclofen in general appears positive. However, this growth must be balanced with efforts to prevent misuse and ensure patient safety[1].

Continuous Monitoring

The pharmaceutical industry and regulatory bodies must continuously monitor the use and misuse of baclofen to ensure that its benefits are maximized while minimizing its risks.

Key Takeaways

  • Increasing Prescriptions: Baclofen prescriptions have seen a significant rise, contributing to projected global sales exceeding $400 million by 2024.
  • Abuse and Misuse: Baclofen is subject to abuse due to its euphoric effects, highlighting the need for careful prescribing and monitoring.
  • Financial Performance: While specific financial data for OZOBAX is limited, the broader pharmaceutical industry trends indicate strong revenue growth in related segments.
  • Patient Support: Programs like the OZOBAX Patient Savings Card help make the medication more accessible to patients.
  • Regulatory Oversight: FDA approval and ongoing regulatory oversight are crucial for ensuring the safety and efficacy of OZOBAX.

FAQs

Q: What is OZOBAX used for?

A: OZOBAX, a brand name for baclofen, is used primarily to treat muscle spasticity and can also be used to reduce cravings in alcohol and heavy smoking.

Q: Is OZOBAX addictive?

A: While not as dangerous as opioid addiction, baclofen can cause euphoria and is subject to abuse. It is important to use it as prescribed by a healthcare provider.

Q: How much does OZOBAX cost?

A: Patients can use the OZOBAX Patient Savings Card to pay as little as $15 for a 30-day supply, with a reimbursement limit of $200 per month.

Q: Are there generic versions of OZOBAX available?

A: Yes, generic versions of baclofen are available, but it is important to be cautious of counterfeit versions sold by fraudulent online pharmacies.

Q: What are the potential risks of using OZOBAX?

A: Besides the risk of abuse, baclofen can be involved in suicide attempts and misuse. It is crucial to monitor its use closely and follow healthcare provider advice.

Sources:

  1. Arrow Passage Recovery - Baclofen Addiction | Non-Opioid Pain-Killer
  2. OZOBAX - Savings & Support - OZOBAX Patients
  3. PR Newswire - Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results
  4. Drugs.com - Generic Ozobax Availability

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