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Last Updated: November 24, 2024

Regulatory Exclusivity: PATENT CHALLENGE


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Drugs with Patent Challenge Regulatory Exclusivity

Click here to include patents covering these drugs in this list

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 ⤷  Sign Up PATENT CHALLENGE
Hikma MIDAZOLAM IN 0.9% SODIUM CHLORIDE midazolam SOLUTION;INTRAVENOUS 216159-002 Apr 17, 2023 AP RX No No ⤷  Sign Up PATENT CHALLENGE
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-001 Jul 31, 2023 DISCN No No ⤷  Sign Up PATENT CHALLENGE
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-002 Jul 31, 2023 DISCN No No ⤷  Sign Up PATENT CHALLENGE
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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