DESMOPRESSIN ACETATE - Generic Drug Details
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What are the generic drug sources for desmopressin acetate and what is the scope of freedom to operate?
Desmopressin acetate
is the generic ingredient in eleven branded drugs marketed by Ferring Pharms Inc, Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Ferring, Sun Pharm Inds, Bausch, Apotex, Sun Pharm, Zydus Pharms, Acerus Pharms, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, and Novast Labs, and is included in thirty-six NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Desmopressin acetate has two hundred and nine patent family members in thirty-six countries.
There are thirteen drug master file entries for desmopressin acetate. Twenty-nine suppliers are listed for this compound.
Summary for DESMOPRESSIN ACETATE
International Patents: | 209 |
US Patents: | 7 |
Tradenames: | 11 |
Applicants: | 27 |
NDAs: | 36 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 10 |
Patent Applications: | 6,923 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for DESMOPRESSIN ACETATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DESMOPRESSIN ACETATE |
What excipients (inactive ingredients) are in DESMOPRESSIN ACETATE? | DESMOPRESSIN ACETATE excipients list |
DailyMed Link: | DESMOPRESSIN ACETATE at DailyMed |
Recent Clinical Trials for DESMOPRESSIN ACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cairo University | N/A |
Genentech, Inc. | Phase 4 |
Indiana Hemophilia &Thrombosis Center, Inc. | Phase 4 |
Pharmacology for DESMOPRESSIN ACETATE
Drug Class | Factor VIII Activator Vasopressin Analog |
Physiological Effect | Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration |
Anatomical Therapeutic Chemical (ATC) Classes for DESMOPRESSIN ACETATE
US Patents and Regulatory Information for DESMOPRESSIN ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-001 | Sep 6, 1995 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 076703-001 | Jan 27, 2005 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aurobindo Pharma | DESMOPRESSIN ACETATE | desmopressin acetate | TABLET;ORAL | 213095-002 | Mar 21, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DESMOPRESSIN ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ferring Pharms Inc | DDAVP | desmopressin acetate | SOLUTION;NASAL | 017922-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-001 | Sep 6, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-002 | Jun 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-002 | Sep 6, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Acerus Pharms | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DESMOPRESSIN ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 105963834 | 鼻内去氨加压素给药 (Intranasal desmopressin administration) | ⤷ Sign Up |
Japan | 2016153420 | 夜間排尿数を低減するためのデスモプレシン (DESMOPRESSIN FOR REDUCING NOCTURNAL VOIDINGS) | ⤷ Sign Up |
Slovenia | 1501534 | ⤷ Sign Up | |
Luxembourg | C00015 | ⤷ Sign Up | |
Poland | 2296686 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DESMOPRESSIN ACETATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3225249 | CA 2019 00023 | Denmark | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504 |
2712622 | 122017000006 | Germany | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504 |
2712622 | LUC00015 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101 |
2712622 | C02712622/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018 |
3225249 | 2019C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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