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FDA Orange Book · active-ingredient family

Desmopressin acetate

Desmopressin acetate is approved as 10 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DESMODA · NDA 219873

10

Brand (NDA)

28

Generics (ANDA)

9

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, spray, metered, tablet

ProductApplicantApplicationTEApproved
DESMODARLDETONNDA 219873—Feb 25, 2026
NOCDURNARLD×2FERRING PHARMS INCNDA 022517—Jun 21, 2018
NOCTIVARLD×2ACERUS PHARMSNDA 201656—Mar 03, 2017
STIMATE (NEEDS NO REFRIGERATION)RLD×2FERRING PHARMS INCNDA 020355—Oct 24, 2007
MINIRINRLDFERRINGNDA 021333—Sep 16, 2002
DDAVPRLD×2FERRING PHARMS INCNDA 019955ABSep 06, 1995
DDAVPRLD×2NORDIC PHARMANDA 018938APMar 30, 1984
DDAVPRLD×3FERRING PHARMS INCNDA 017922—Approved Prior to Jan 1, 1982
DESMOPRESSIN ACETATE×2FERRINGNDA 021795—May 08, 2008
CONCENTRAIDFERRINGNDA 019776—Dec 26, 1990

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
DESMOPRESSIN ACETATECAPLINANDA 219981APFeb 27, 2026
DESMOPRESSIN ACETATE×2AUROBINDO PHARMAANDA 213095ABMar 21, 2024
DESMOPRESSIN ACETATEGLANDANDA 216904APMar 20, 2023
DESMOPRESSIN ACETATEGLANDANDA 216922APNov 16, 2022
DESMOPRESSIN ACETATEDR REDDYSANDA 215961APAug 19, 2022
DESMOPRESSIN ACETATEUBIANDA 210223APSep 17, 2020
DESMOPRESSIN ACETATEUBIANDA 210218APFeb 14, 2020
DESMOPRESSIN ACETATE×2NOVAST LABSANDA 208357ABJun 06, 2019
DESMOPRESSIN ACETATEAM REGENTANDA 091374—Feb 14, 2019
DESMOPRESSIN ACETATE×2ABHAI LLCANDA 210371ABJan 28, 2019
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)ZYDUS PHARMSANDA 091345ABOct 03, 2017
DESMOPRESSIN ACETATESAGENT PHARMS INCANDA 204695APAug 22, 2017
DESMOPRESSIN ACETATESAGENT PHARMS INCANDA 204751APAug 22, 2017
DESMOPRESSIN ACETATE×2HERITAGE PHARMAANDA 207880ABMay 26, 2017
DESMOPRESSIN ACETATE×2GLENMARK PHARMS LTDANDA 201831—May 28, 2015
DESMOPRESSIN ACETATE×2NATCO PHARMA USAANDA 200653—Jun 27, 2014
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)SUN PHARMANDA 078271—Dec 23, 2013
DESMOPRESSIN ACETATESUN PHARM INDS LTDANDA 091280—Jan 25, 2013
DESMOPRESSIN ACETATESUN PHARM INDSANDA 077212—Apr 12, 2012
DESMOPRESSIN ACETATE×2APOTEXANDA 077414ABMar 07, 2006
DESMOPRESSIN ACETATE×2IMPAX LABS INCANDA 077122—Jan 25, 2006
DESMOPRESSIN ACETATE×2ACTAVIS LABS FL INCANDA 076470—Jul 01, 2005
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)APOTEXANDA 076703ABJan 27, 2005
DESMOPRESSIN ACETATEHOSPIRAANDA 075220—Aug 28, 2000
DESMOPRESSIN ACETATEBEDFORDANDA 074575—Feb 18, 2000
DESMOPRESSIN ACETATE PRESERVATIVE FREEBEDFORDANDA 074574—Feb 18, 2000
DESMOPRESSIN ACETATEBAUSCHANDA 074830ABJan 25, 1999
DESMOPRESSIN ACETATEMEITHEALANDA 074888APOct 15, 1997

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11963995May 21, 2029in 3 yr
U-2327
11020448May 21, 2029in 3 yr
U-2327
10137167May 21, 2029in 3 yr
U-2327
9974826Apr 13, 2030in 3 yr 10 mo
U-2326
11419914Jun 15, 2030in 4 yr 1 mo
U-3431
12090190Jun 15, 2030in 4 yr 1 mo
ProductU-4003
9539302Jun 15, 2030in 4 yr 1 mo
Product
12343372Apr 03, 2044in 18 yr 1 mo
ProductU-4432
12214010Apr 03, 2044in 18 yr 1 mo
Product

Desmopressin acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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