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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

Last Updated: October 2, 2023

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. Fifty-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
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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