Details for New Drug Application (NDA): 212728
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NDA 212728 describes NURTEC ODT, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the NURTEC ODT profile page.
The generic ingredient in NURTEC ODT is rimegepant sulfate. Two suppliers are listed for this compound. Additional details are available on the rimegepant sulfate profile page.
The generic ingredient in NURTEC ODT is rimegepant sulfate. Two suppliers are listed for this compound. Additional details are available on the rimegepant sulfate profile page.
Summary for 212728
| Tradename: | NURTEC ODT |
| Applicant: | Pfizer |
| Ingredient: | rimegepant sulfate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212728
Generic Entry Date for 212728*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, ORALLY DISINTEGRATING;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 212728
| Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Suppliers and Packaging for NDA: 212728
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728 | NDA | Pfizer Laboratories Div Pfizer Inc | 72618-3000 | 72618-3000-2 | 1 BLISTER PACK in 1 CARTON (72618-3000-2) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728 | NDA | Pfizer Laboratories Div Pfizer Inc | 72618-3001 | 72618-3001-2 | 4 DOSE PACK in 1 CARTON (72618-3001-2) / 1 BLISTER PACK in 1 DOSE PACK (72618-3001-1) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Feb 27, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,083,724 | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS | ||||||||
| Patent: | 11,083,724 | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS | ||||||||
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