Details for New Drug Application (NDA): 022517
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NDA 022517 describes NOCDURNA, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the NOCDURNA profile page.
The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 022517
| Tradename: | NOCDURNA |
| Applicant: | Ferring Pharms Inc |
| Ingredient: | desmopressin acetate |
| Patents: | 5 |
Suppliers and Packaging for NDA: 022517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517 | NDA | Antares Pharma, Inc. | 54436-325 | 54436-325-30 | 3 BLISTER PACK in 1 CARTON (54436-325-30) / 10 TABLET in 1 BLISTER PACK (54436-325-10) |
| NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517 | NDA | Antares Pharma, Inc. | 54436-350 | 54436-350-30 | 3 BLISTER PACK in 1 CARTON (54436-350-30) / 10 TABLET in 1 BLISTER PACK (54436-350-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | 0.0277MG | ||||
| Approval Date: | Jun 21, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 11,020,448 | Patent Expiration: | May 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION | ||||||||
| Patent: | 11,963,995 | Patent Expiration: | May 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION | ||||||||
| Patent: | 7,560,429 | Patent Expiration: | Feb 2, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS | ||||||||
Expired US Patents for NDA 022517
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | 9,220,747 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | 9,220,747 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | 9,504,647 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | 10,307,459 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | 7,947,654 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | 8,802,624 | ⤷ Subscribe |
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | 10,307,459 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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