MONISTAT 5 Drug Patent Profile
When do Monistat 5 patents expire, and when can generic versions of Monistat 5 launch?
Monistat 5 is a drug marketed by Personal Prods and is included in one NDA.
The generic ingredient in MONISTAT 5 is miconazole nitrate. There is one drug master file entry for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monistat 5
A generic version of MONISTAT 5 was approved as miconazole nitrate by ACTAVIS PHARMA on November 19th, 1993.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for MONISTAT 5?
- What are the global sales for MONISTAT 5?
- What is Average Wholesale Price for MONISTAT 5?
Summary for MONISTAT 5
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,474 |
| DailyMed Link: | MONISTAT 5 at DailyMed |
Recent Clinical Trials for MONISTAT 5
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto" | Phase 4 |
| Universidad Autonoma de San Luis Potosà | Phase 4 |
US Patents and Regulatory Information for MONISTAT 5
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Personal Prods | MONISTAT 5 | miconazole nitrate | TAMPON;VAGINAL | 018592-001 | Oct 27, 1989 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |

