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Last Updated: February 29, 2024

Regulatory Exclusivity: NEW PRODUCT


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Drugs with New Product Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Redhill TALICIA amoxicillin; omeprazole magnesium; rifabutin CAPSULE, DELAYED RELEASE;ORAL 213004-001 Nov 1, 2019 RX Yes Yes ⤷  Try a Trial NEW PRODUCT
Omnivium Pharms NUMBRINO cocaine hydrochloride SOLUTION;NASAL 209575-001 Jan 10, 2020 RX Yes Yes ⤷  Try a Trial NEW PRODUCT
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No ⤷  Try a Trial NEW PRODUCT
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No ⤷  Try a Trial NEW PRODUCT
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes ⤷  Try a Trial NEW PRODUCT
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial NEW PRODUCT
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ⤷  Try a Trial NEW PATIENT POPULATION
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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