Details for New Drug Application (NDA): 203752
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NDA 203752 describes MINIVELLE, which is a drug marketed by Noven and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the MINIVELLE profile page.
The generic ingredient in MINIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
The generic ingredient in MINIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Pharmacology for NDA: 203752
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 203752
Suppliers and Packaging for NDA: 203752
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752 | NDA AUTHORIZED GENERIC | Noven Therapeutics, LLC | 68968-3410 | 68968-3410-8 | 8 POUCH in 1 CARTON (68968-3410-8) / 1 d in 1 POUCH |
| MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752 | NDA AUTHORIZED GENERIC | Noven Therapeutics, LLC | 68968-3425 | 68968-3425-8 | 8 POUCH in 1 CARTON (68968-3425-8) / 1 d in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.0375MG/24HR | ||||
| Approval Date: | Oct 29, 2012 | TE: | AB3 | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 4, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 10, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 10, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 203752
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-002 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-002 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-003 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-005 | Sep 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-004 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-004 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-002 | Oct 29, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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