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Last Updated: August 17, 2022

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 and one Paragraph IV challenge.

The generic ingredient in OZOBAX is baclofen. There are twenty-one drug master file entries for this compound. Forty-four 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: 2
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in OZOBAX?OZOBAX excipients list
DailyMed Link:OZOBAX at DailyMed
Drug patent expirations by year for OZOBAX
Paragraph IV (Patent) Challenges for OZOBAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OZOBAX Oral Solution baclofen 5 mg/5 mL 208193 1 2021-07-26

US Patents and Regulatory Information for OZOBAX

OZOBAX is protected by one US patents.

Patents protecting OZOBAX

Oral baclofen solutions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SPASTICITY

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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Moodys
Boehringer Ingelheim
Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.