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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Medtronic
Johnson and Johnson
McKesson
Merck

Last Updated: March 20, 2023

Regulatory Exclusivity Expiring in 2029


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Drugs with Regulatory Exclusivity Expiring in 2029

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Dare XACIATO clindamycin phosphate GEL;VAGINAL 215650-001 Dec 7, 2021 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Shionogi Inc FETROJA cefiderocol sulfate tosylate POWDER;INTRAVENOUS 209445-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Mylan Ireland Ltd PRETOMANID pretomanid TABLET;ORAL 212862-001 Aug 14, 2019 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Msd Merck Co RECARBRIO cilastatin sodium; imipenem; relebactam POWDER;INTRAVENOUS 212819-001 Jul 16, 2019 RX Yes Yes See Plans and Pricing GENERATING ANTIBIOTIC INCENTIVES NOW
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No See Plans and Pricing PEDIATRIC EXCLUSIVITY
>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:

Merck
Express Scripts
Moodys
McKesson
AstraZeneca
McKinsey

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