Regulatory Exclusivity: NEW STRENGTH
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Drugs with New Strength 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-003 | Apr 28, 2021 | RX | Yes | Yes | ⤷ Sign Up | NEW STRENGTH | |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-007 | Jul 9, 2021 | DISCN | Yes | No | ⤷ Sign Up | NEW STRENGTH | |
| Janssen Pharms | INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-005 | Aug 30, 2021 | RX | Yes | No | ⤷ Sign Up | NEW STRENGTH | |
| Janssen Pharms | INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-006 | Aug 30, 2021 | RX | Yes | No | ⤷ Sign Up | NEW STRENGTH | |
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-003 | Sep 2, 2022 | RX | Yes | No | ⤷ Sign Up | NEW STRENGTH | |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-009 | Apr 14, 2023 | RX | Yes | Yes | ⤷ Sign Up | NEW STRENGTH | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
