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DESMOPRESSIN ACETATE - Generic Drug Details

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What are the generic sources for desmopressin acetate and what is the scope of desmopressin acetate freedom to operate?

Desmopressin acetate is the generic ingredient in ten branded drugs marketed by Ferring Pharms Inc, Bedford, Hospira, Sagent Pharms, Sun Pharm Inds Ltd, Teva Pharms Usa, Ferring, Sun Pharm Inds, Bausch And Lomb, Apotex Inc, Sun Pharma Global, Zydus Pharms Usa Inc, Avadel Speclt, Actavis Labs Fl Inc, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, and Mylan Pharms Inc, and is included in twenty-six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desmopressin acetate has eighty-nine patent family members in thirty countries.

There are twenty drug master file entries for desmopressin acetate. Twenty-seven suppliers are listed for this compound.

Summary for DESMOPRESSIN ACETATE

International Patents:	89
US Patents:	4
Tradenames:	10
Applicants:	18
NDAs:	26
Drug Master File Entries:	20
Suppliers / Packagers:	27
Bulk Api Vendors:	88
Clinical Trials:	1,019
Patent Applications:	912
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESMOPRESSIN ACETATE
DailyMed Link:	DESMOPRESSIN ACETATE at DailyMed

Pharmacology for DESMOPRESSIN ACETATE

Ingredient-type	Vasopressins
Drug Class	Factor VIII Activator Vasopressin Analog
Physiological Effect	Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Synonyms for DESMOPRESSIN ACETATE

(2S)-N-[(2R)-1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-

(Deamino-Cys1,D-Arg8)-Vasopressin

(DEAMINO-CYS1,D-ARG8)-VASOPRESSIN ACETATE

(DEAMINO-CYS1,D-ARG8)-VASOPRESSIN ACETATE SALT

(S)-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-pentaazacycloicosane-4-carbonyl)-N-((R)-1-((2-amino-2-oxoethyl)amino)-5-g

(S)-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-pentaazacycloicosane-4-carbonyl)-N-((R)-1-(2-amino-2-oxoethylamino)-5-gua

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-{[(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 acetate--wa

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

2-({1-[13-BENZYL-10-(2-CARBAMOYLETHYL)-7-(CARBAMOYLMETHYL)-16-[(4-HYDROXYPHENYL)METHYL]-6,9,12,15,18-PENTAOXO-1,2-DITHIA-5,8,11,14,17-PENTAAZACYCLOICOSANE-4-CARBONYL]PYRROLIDIN-2-YL}FORMAMIDO)-N-(CARBAMOYLMETHYL)-5-[(DIAMINOM

242K8LE2BC

3-MERCAPTOPROPIONYL-TYR-PHE-GLN-ASN-CYS-PRO-D-ARG-GLY-NH2 (DISULFIDE BOND) ACETATE SALT

3-MERCAPTOPROPIONYL-TYR-PHE-GLN-ASN-CYS-PRO-D-ARG-GLY-NH2 ACETATE SALT (DISULFIDE BOND)

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

acetic acid; 1-[7-(2-amino-2-oxo-ethyl)-10-(3-amino-3-oxo-propyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl]-N-[1-[(2-amino-2-oxo-ethyl)carbamoyl]-4-gu

acetic acid; N-[1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[[7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-13-(phenylmethyl)-1,2-dithia-5

acetic acid; N-[1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,

Adiuretin

ADIURETIN ACETATE

Adiuretin SD

ADIURETIN SD ACETATE

AKOS015994650

AKOS025311518

AKOS030485983

AKOS030573306

AM000474

AM000514

AM010547

AN-7545

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 ACETATE SALT

DDAVP Nasal Spray

DDAVP Rhinal Tube

Deamino Arginine Vasopressin

DEAMINO ARGININE VASOPRESSIN ACETATE

Deamino-8-D-arginine, l-, vasopressin

Demopressin acetate

Desamino-8-D-arginine vasopressin, l-

Desmopresina

Desmopresina [INN-Spanish]

DESMOPRESINA ACETATE

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 SALT

Desmopressin acetate trihydrate

Desmopressin Acetate(1:2)

Desmopressin Acetate(STIMATE, DDAVP)/

Desmopressin diacetate

Desmopressin diacetate anhydrous

Desmopressin monoacetate

Desmopressine

Desmopressine [INN-French]

DESMOPRESSINE ACETATE

Desmopressinum

Desmopressinum [INN-Latin]

DESMOPRESSINUM ACETATE

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

MINIRIN ACETATE

Minirine

minirinmelt

Minirinmelt (TN)

MLSVJHOYXJGGTR-IFHOVBQLSA-N

MolPort-006-069-425

N-[1-[(2-azanyl-2-oxidanylidene-ethyl)amino]-5-[bis(azanyl)methylideneamino]-1-oxidanylidene-pentan-2-yl]-1-[[7-(2-azanyl-2-oxidanylidene-ethyl)-10-(3-azanyl-3-oxidanylidene-propyl)-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-p

NCGC00181133-01

NCGC00181133-02

NCGC00263573-01

NFLWUMRGJYTJIN-PNIOQBSNSA-N

Octim

Octostim

Presinex

SC-18848

SCH2CH2CO-TYR-PHE-GLN-ASN-CYS-PRO-D-ARG-GLY-NH2 ACETATE

SCHEMBL1172203

SCHEMBL14027607

SCHEMBL204511

Stimate

Stimate (TN)

STIMATE ACETATE

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

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
Sagent Pharms	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	204751-001	Aug 22, 2017	AP	RX	No	No
Glenmark Pharms Ltd	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	201831-002	May 28, 2015	AB	RX	No	No
Sun Pharm Inds Ltd	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091280-001	Jan 25, 2013	AP	RX	No	No
Zydus Pharms Usa Inc	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	091345-001	Oct 3, 2017	AB	RX	No	No

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Expired US Patents for DESMOPRESSIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-002	Apr 25, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-001	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995

Non-Orange Book US Patents for DESMOPRESSIN ACETATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,560,429	Orodispersible dosage forms of desmopressin acetate
7,947,654	Pharmaceutical formulations
8,143,225	Pharmaceutical compositions including low dosages of desmopressin
8,802,624	Methods of treatment using orodispersible desmopressin pharmaceutical formulations

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International Patents for DESMOPRESSIN ACETATE

Country	Document Number	Estimated Expiration
Brazil	0309819
Portugal	2442821
Norway	335167
Japan	5959076