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Harvard Business School

Last Updated: June 4, 2023

Regulatory Exclusivity: PATENT CHALLENGE


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Drugs with Patent Challenge Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Bionpharma Inc ENALAPRIL MALEATE enalapril maleate SOLUTION;ORAL 212408-001 Aug 10, 2021 AB RX No No ⤷  Try a Trial PATENT CHALLENGE
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209148-001 Oct 17, 2018 AB RX No No ⤷  Try a Trial PATENT CHALLENGE
Teva Pharms Usa NALOXONE HYDROCHLORIDE naloxone hydrochloride SPRAY, METERED;NASAL 209522-001 Apr 19, 2019 AB RX No No ⤷  Try a Trial PATENT CHALLENGE
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
McKinsey
Dow
Boehringer Ingelheim
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.