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 one supplier. 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. One supplier is 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. One supplier is 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
*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 | 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 |
| VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902 | NDA | ANI Pharmaceuticals, Inc. | 62559-385 | 62559-385-30 | 1 TUBE in 1 CARTON (62559-385-30) / 30 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: | ⤷ Sign Up | Patent Expiration: | Oct 2, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF GENITAL WARTS | ||||||||
| Patent: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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