Regulatory Exclusivity: ORPHAN DRUG EXCLUSIVITY
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Drugs with Orphan Drug Exclusivity Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie Inc | DUOPA | carbidopa; levodopa | SUSPENSION;ENTERAL | 203952-001 | Jan 9, 2015 | RX | Yes | Yes | See Plans and Pricing | TREATMENT OF MOTOR FLUCTUATIONS IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE | |
| Baxter Hlthcare Corp | PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER | calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate | INJECTABLE;INJECTION | 207026-002 | Jan 13, 2015 | RX | Yes | Yes | See Plans and Pricing | AS A REPLACEMENT SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND IN CASE OF DRUG POISONING WHEN CRRT IS USED TO REMOVE DIALYZABLE SUBSTANCES | |
| Baxter Hlthcare Corp | PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER | calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate | INJECTABLE;INJECTION | 207026-001 | Jan 13, 2015 | RX | Yes | Yes | See Plans and Pricing | AS A REPLACEMENT SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND IN CASE OF DRUG POISONING WHEN CRRT IS USED TO REMOVE DIALYZABLE SUBSTANCES | |
| Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | See Plans and Pricing | TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
