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 |
