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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alk Abello | OTIPRIO | ciprofloxacin | INJECTABLE, SUSPENSION;OTIC | 207986-001 | Dec 10, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | ||||
| Emd Serono Inc | MAVENCLAD | cladribine | TABLET;ORAL | 022561-001 | Mar 29, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | TREATING NON-EARLY SPMS BY ADMINISTERING ORAL CLADRIBINE AT A FIXED DOSE PER PATIENT, PER BODY WEIGHT AND PER TREATMENT YEAR, WHICH FIXED DOSE IS 1.75 +/- 0.2 MG/KG, TO BE ADMINISTERED WITHIN MONTHS 1 AND 2 IN EACH OF 2 ADJACENT TREATMENT YEARS | ||||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-001 | Feb 17, 2022 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | |||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-002 | Feb 17, 2022 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | |||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-003 | Feb 17, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | |||
| Alnylam Pharms Inc | OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103-001 | Nov 23, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
