Details for New Drug Application (NDA): 021902
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NDA 021902 describes VEREGEN, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the VEREGEN profile page.
The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sinecatechins profile page.
The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sinecatechins profile page.
Summary for 021902
| Tradename: | VEREGEN |
| Applicant: | Ani Pharms |
| Ingredient: | sinecatechins |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021902
Generic Entry Date for 021902*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;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.
Suppliers and Packaging for NDA: 021902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902 | NDA | PharmaDerm a division of Fougera Pharmaceuticals Inc. | 10337-450 | 10337-450-08 | 1 TUBE in 1 CARTON (10337-450-08) / 2 g in 1 TUBE |
| VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902 | NDA | ANI Pharmaceuticals, Inc. | 62559-385 | 62559-385-26 | 6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 15% | ||||
| Approval Date: | Oct 31, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 2, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF GENITAL WARTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 12, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF GENITAL WARTS | ||||||||
Expired US Patents for NDA 021902
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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