Drugs with New Strength Regulatory Exclusivity
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-009 | Apr 14, 2023 | RX | Yes | Yes | ⤷ Get Started Free | NEW STRENGTH | |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-003 | May 12, 2023 | RX | Yes | Yes | ⤷ Get Started Free | NEW STRENGTH | |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-004 | Oct 2, 2023 | RX | Yes | No | ⤷ Get Started Free | NEW STRENGTH | |
| Arcutis | ZORYVE | roflumilast | CREAM;TOPICAL | 215985-002 | Jul 9, 2024 | RX | Yes | Yes | ⤷ Get Started Free | NEW STRENGTH | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
