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DESMOPRESSIN ACETATE - Generic Drug Details
What are the generic 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, Hospira, Sagent Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, Ferring, Sun Pharm Inds, Bausch And Lomb, Apotex Inc, Sun Pharm, Zydus Pharms, Alyvant, Abhai Llc, Actavis Labs Fl Inc, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Mylan, and Novast Labs, and is included in thirty NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Desmopressin acetate has one hundred and ninety-one patent family members in thirty-five countries.
There are twenty drug master file entries for desmopressin acetate. Twenty suppliers are listed for this compound.
Summary for DESMOPRESSIN ACETATE
| International Patents: | 191 |
| US Patents: | 13 |
| Tradenames: | 11 |
| Applicants: | 21 |
| NDAs: | 30 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 20 |
| Bulk Api Vendors: | 107 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,007 |
| 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 |
| DailyMed Link: | DESMOPRESSIN ACETATE at DailyMed |
Recent Clinical Trials for DESMOPRESSIN ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| University Hospitals Cleveland Medical Center | Phase 2 |
| Teva Pharmaceuticals USA | Phase 1 |
Recent Litigation for DESMOPRESSIN ACETATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Ferring B v. v. Allergan Inc. | 2012-04-05 |
| Ferring BV v. Teva Pharmaceuticals | 2004-07-20 |
See all DESMOPRESSIN ACETATE litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2015-04-16 |
Pharmacology for DESMOPRESSIN ACETATE
| Drug Class | Factor VIII Activator Vasopressin Analog |
| Physiological Effect | Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration |
Synonyms for DESMOPRESSIN ACETATE
| (Deamino-Cys1,D-Arg8)-Vasopressin |
| 1-(3-Mercaptopropanoic Acid)-8-d-arginine Vasopressin Monoacetate |
| 1-(3-mercaptopropanoic acid)-8-D-arginine vasopression monoacetate trihydrate |
| 1-(3-Mercaptopropanoic acid)-8-D-argininevasopressin monoacetate (salt), trihydrate |
| 1-(3-Mercaptopropionic acid)-8-D-arginine vasopression monoacetate |
| 1-(3-mercaptopropionic acid)-8-D-arginine vasopression monoacetate trihydrate |
| 1-(3-mercaptopropionic acid)-8-D-arginine-vasopressin |
| 1-(3-Mercaptopropionic acid)-8-D-arginine-vasopressin diacetate |
| 1-(3-Mercaptopropionic acid)-8-D-arginine-vasopressin monoacetate (salt) trihydrate |
| 1-(7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carbonyl)-N-(1-((2-amino-2-o |
| 1-{[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl}-L-prolyl-D-arginylglycinamide |
| 1-{[7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl}prolyl-n5-(diaminomethylidene)ornithylglycinamide acetate(1:1) |
| 1-{[7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-(4-hydroxybenzyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl}prolyl-n5-(diaminomethylidene)ornithylglycinamide acetate(1:2) |
| 1-Deamino-8-D-arginine vasopressin |
| 1-deamino-8-D-arginine vasopressin acetate trihydrate |
| 1-Deamino-8-D-arginine-vasopressin diacetate |
| 1-Desamino-8-D-arginine vasopressin |
| 1-desamino-8-D-arginine vasopressin acetate trihydrate |
| 16679-58-6 |
| 16679-58-6 (Parent) |
| 16789-98-3 |
| 1K12647SFC |
| 242K8LE2BC |
| 3576AH |
| 3577AH |
| 357D862 |
| 62288-83-9 |
| 62288-83-9 (monoacetate) |
| 62357-86-2 |
| 62357-86-2 (monoacetate trihydrate) |
| 679D586 |
| 789D983 |
| 8-d-Arginine-1-(3-mercapto-propanoic Acid)vasopresin Monoacetate |
| A810919 |
| A833738 |
| ABP000576 |
| AC1L21V2 |
| AC1L21V5 |
| AC1L506T |
| AC1NSJXN |
| AC1Q5SZE |
| AC1Q5T0K |
| Adiuretin SD |
| AKOS015994650 |
| AKOS025311518 |
| AKOS030485983 |
| AKOS030573306 |
| AN-7545 |
| BCP13206 |
| BCP15458 |
| BDBM50205308 |
| C46H64N14O12S2 |
| C46H64N14O12S2.C2H4O2 |
| C46H64N14O12S2.C2H4O2.3H2O |
| CAS-62288-83-9 |
| CD-644 |
| CHEBI:4450 |
| CHEBI:59728 |
| CHEMBL1200556 |
| CHEMBL1429 |
| CHEMBL2138698 |
| CHEMBL2358584 |
| CONCENTRAID |
| CS-0952 |
| CTK8F9082 |
| D02235 |
| DDAVP |
| DDAVP (NEEDS NO REFRIGERATION) |
| DDAVP (TN) |
| DDAVP ACETATE |
| DDAVP Nasal Spray |
| DDAVP Rhinal Tube |
| Deamino Arginine Vasopressin |
| Deamino-8-D-arginine, l-, vasopressin |
| Demopressin acetate |
| Desamino-8-D-arginine vasopressin, l- |
| Desmopresina |
| Desmopresina [INN-Spanish] |
| DESMOPRESSIN |
| Desmopressin (Acetate) |
| Desmopressin [INN:BAN] |
| Desmopressin acetate (needs NO refrigeration) |
| Desmopressin acetate (USAN) |
| Desmopressin acetate [USAN:JAN] |
| Desmopressin acetate [USAN:USP:JAN] |
| Desmopressin acetate anhydrous |
| Desmopressin acetate hydrate |
| Desmopressin acetate hydrate (JAN) |
| DESMOPRESSIN ACETATE PRESERVATIVE FREE |
| Desmopressin acetate trihydrate |
| Desmopressin Acetate(1:2) |
| Desmopressin Acetate(STIMATE, DDAVP)/ |
| Desmopressin diacetate |
| Desmopressin diacetate anhydrous |
| Desmopressine |
| Desmopressine [INN-French] |
| Desmopressinum |
| Desmopressinum [INN-Latin] |
| Desmospray |
| DSSTox_CID_26864 |
| DSSTox_GSID_46864 |
| DSSTox_RID_81971 |
| DTXSID4046864 |
| EINECS 240-726-7 |
| ENR1LLB0FP |
| FT-0603106 |
| FT-0624526 |
| FT-0653786 |
| FT-0688024 |
| H661 |
| HS-2010 |
| HY-17370 |
| KS-00002WUQ |
| KW-8008 |
| LS-161413 |
| Minirin |
| Minirine |
| Minirinmelt (TN) |
| MLSVJHOYXJGGTR-IFHOVBQLSA-N |
| MolPort-006-069-425 |
| NCGC00181133-01 |
| NCGC00181133-02 |
| NCGC00263573-01 |
| NFLWUMRGJYTJIN-PNIOQBSNSA-N |
| Octim |
| Octostim |
| Presinex |
| SC-18848 |
| SCHEMBL1172203 |
| SCHEMBL14027607 |
| SCHEMBL204511 |
| Stimate |
| Stimate (TN) |
| Stimate injection |
| Stimate Nasal Spray |
| Tox21_112740 |
| Tox21_112740_1 |
| UNII-1K12647SFC |
| UNII-242K8LE2BC |
| UNII-ENR1LLB0FP |
| UNII-XB13HYU18U |
| VA10693 |
| Vasopressin, 1-(3-mercaptopropanoic acid)-8-D-arginine- |
| Vasopressin, 1-(3-mercaptopropanoic acid)-8-D-arginine-, diacetate (salt) |
| Vasopressin, 1-(3-mercaptopropanoic acid)-8-D-arginine-, monoacetate (salt) |
| Vasopressin, 1-(3-mercaptopropanoic acid)-8-D-arginine-, monoacetate (salt), trihydrate |
| W-5074 |
| XB13HYU18U |
| xoethyl)amino)-5-((diaminomethylene)amino)-1-oxopentan-2-yl)pyrrolidine-2-carboxamide diacetate |
Paragraph IV (Patent) Challenges for DESMOPRESSIN ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DDAVP | SOLUTION;NASAL | desmopressin acetate | 017922 | |
| DDAVP | TABLET;ORAL | desmopressin acetate | 019955 | |
| DDAVP | SPRAY, METERED;NASAL | desmopressin acetate | 017922 | |
| DDAVP (NEEDS NO REFRIGERATION) | SPRAY, METERED;NASAL | desmopressin acetate | 017922 | |
| DDAVP | INJECTABLE;INJECTION | desmopressin acetate | 018938 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | DESMOPRESSIN ACETATE | desmopressin acetate | TABLET;ORAL | 077122-002 | Jan 25, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm Inds | DESMOPRESSIN ACETATE | desmopressin acetate | SOLUTION;NASAL | 077212-001 | Apr 12, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Sagent Pharms Inc | DESMOPRESSIN ACETATE | desmopressin acetate | INJECTABLE;INJECTION | 204695-001 | Aug 22, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Bausch And Lomb | DESMOPRESSIN ACETATE | desmopressin acetate | SPRAY, METERED;NASAL | 074830-001 | Jan 25, 1999 | AB | RX | No | Yes | 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 |
Expired US Patents for DESMOPRESSIN ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-002 | Sep 6, 1995 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-001 | Sep 6, 1995 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 017922-003 | Aug 7, 1996 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | SOLUTION;NASAL | 017922-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | INJECTABLE;INJECTION | 018938-001 | Mar 30, 1984 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | INJECTABLE;INJECTION | 018938-002 | Apr 25, 1995 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-002 | Sep 6, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DESMOPRESSIN ACETATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100632455 | Start Trial |
| European Patent Office | 3278809 | Start Trial |
| Poland | 208482 | Start Trial |
| Denmark | 3225250 | Start Trial |
| Austria | 333886 | Start Trial |
| Lithuania | C2712622 | Start Trial |
| Japan | 2018035198 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DESMOPRESSIN ACETATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3225249 | 2019C/520 | Belgium | Start Trial | PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513 |
| 2712622 | 122017000006 | Germany | Start Trial | 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 | PA2017001,C2712622 | Lithuania | Start Trial | PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008 |
| 2712622 | C02712622/01 | Switzerland | Start Trial | PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018 |
| 3225249 | CA 2019 00023 | Denmark | Start Trial | PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504 |
| 3225249 | 300983 | Netherlands | Start Trial | PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513 |
| 2712622 | PA2017001 | Lithuania | Start Trial | PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
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