Details for New Drug Application (NDA): 201656
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NDA 201656 describes NOCTIVA, which is a drug marketed by Acerus Pharms and is included in one NDA. There are four patents protecting this drug. Additional details are available on the NOCTIVA profile page.
The generic ingredient in NOCTIVA 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 NOCTIVA 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 201656
| Tradename: | NOCTIVA |
| Applicant: | Acerus Pharms |
| Ingredient: | desmopressin acetate |
| Patents: | 4 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY, METERED;NASAL | Strength | 0.00083MG/SPRAY | ||||
| Approval Date: | Mar 3, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 15, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 15, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF 0.75 MCG OR 1.5 MCG DESMOPRESSIN | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 26, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 201656
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-002 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-002 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-002 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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