Details for New Drug Application (NDA): 202317
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NDA 202317 describes VALCHLOR, which is a drug marketed by Helsinn and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VALCHLOR profile page.
The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.
The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.
Summary for 202317
| Tradename: | VALCHLOR |
| Applicant: | Helsinn |
| Ingredient: | mechlorethamine hydrochloride |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202317
Generic Entry Date for 202317*:
Constraining patent/regulatory exclusivity:
Dosage:
GEL;TOPICAL |
*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: 202317
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 202317
Suppliers and Packaging for NDA: 202317
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALCHLOR | mechlorethamine hydrochloride | GEL;TOPICAL | 202317 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-120 | 69639-120-01 | 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | EQ 0.016% BASE | ||||
| Approval Date: | Aug 23, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 7,838,564 | Patent Expiration: | Mar 7, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,872,050 | Patent Expiration: | Jul 8, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN DIRECTED THERAPY | ||||||||
| Patent: | 8,450,375 | Patent Expiration: | Mar 7, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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