Details for New Drug Application (NDA): 212862
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NDA 212862 describes PRETOMANID, which is a drug marketed by Mylan Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PRETOMANID profile page.
The generic ingredient in PRETOMANID is pretomanid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pretomanid profile page.
The generic ingredient in PRETOMANID is pretomanid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pretomanid profile page.
Summary for 212862
| Tradename: | PRETOMANID |
| Applicant: | Mylan Ireland Ltd |
| Ingredient: | pretomanid |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212862
Generic Entry Date for 212862*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
TABLET;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: 212862
| Mechanism of Action | Organic Anion Transporter 3 Inhibitors |
Suppliers and Packaging for NDA: 212862
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRETOMANID | pretomanid | TABLET;ORAL | 212862 | NDA | Viatris Specialty LLC | 49502-476 | 49502-476-26 | 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 14, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 14, 2029 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Aug 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED AS PART OF A COMBINATION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONARY EXTENSIVELY DRUG RESISTANT (XDR) OR TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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