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Last Updated: April 13, 2024

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
Hikma MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 216159-001 Apr 17, 2023 AP RX No No ⤷  Try a Trial PATENT CHALLENGE
Hikma MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 216159-002 Apr 17, 2023 AP RX No No ⤷  Try a Trial PATENT CHALLENGE
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-001 Jul 31, 2023 DISCN No No ⤷  Try a Trial PATENT CHALLENGE
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-002 Jul 31, 2023 DISCN No No ⤷  Try a Trial PATENT CHALLENGE
Aurobindo Pharma SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972-001 Jul 31, 2023 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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