Is there a generic for Desmopressin acetate?

Yes. The FDA Orange Book lists 28 approved generic (ANDA) applications for Desmopressin acetate, referencing the brand DESMODA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Desmopressin acetate?

DESMODA (NDA 219873, ETON) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Desmopressin acetate?

The Orange Book lists 9 patents against Desmopressin acetate products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Desmopressin acetate are approved?

Desmopressin acetate is approved in the following dosage forms: injectable, solution, spray, metered, tablet.

FDA Orange Book · active-ingredient family

Desmopressin acetate

Desmopressin acetate: 10 brands, 28 generics; first approved Mar 30, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 28 ANDA applications approved.

Earliest patent expiry May 21, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 21, 2029

in 2 yr 10 mo

Brand (NDA) products

Originator applications

DESMODARLDRS
ETONNDA 2198732026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/ML SOLUTION ORAL Rx —
NOCDURNARLD
FERRING PHARMS INCNDA 02251720182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.0277MG TABLET SUBLINGUAL Discontinued —
0.0553MG TABLET SUBLINGUAL Discontinued —
NOCTIVARLD
ACERUS PHARMSNDA 20165620172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.00083MG/SPRAY SPRAY, METERED NASAL Discontinued —
0.00166MG/SPRAY SPRAY, METERED NASAL Discontinued —
STIMATE (NEEDS NO REFRIGERATION)RLD
FERRING PHARMS INCNDA 02035520072 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15MG/SPRAY SPRAY, METERED NASAL Discontinued —
0.15MG/SPRAY SPRAY, METERED NASAL Discontinued —
MINIRINRLD
FERRINGNDA 0213332002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01MG/SPRAY SPRAY, METERED NASAL Discontinued —
DDAVPRLD
FERRING PHARMS INCNDA 01995519952 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DDAVPRLDRS
J MOLNERNDA 01893819842 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
0.015MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/ML	SOLUTION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.0277MG	TABLET	SUBLINGUAL	Discontinued	—
0.0553MG	TABLET	SUBLINGUAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.00083MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—
0.00166MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—
0.15MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP
0.015MG/ML	INJECTABLE	INJECTION	Discontinued	—

DDAVPRLD

FERRING PHARMS INCNDA 017922—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION	NASAL	Discontinued	—
0.01MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—
0.01MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

DESMOPRESSIN ACETATE
FERRINGNDA 02179520082 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
CONCENTRAID
FERRINGNDA 0197761990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION NASAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (28)

Abbreviated applications

DESMOPRESSIN ACETATE
CAPLINANDA 2199812026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
AUROBINDO PHARMAANDA 21309520242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DESMOPRESSIN ACETATE
GLANDANDA 2169042023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
GLANDANDA 2169222022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
DR REDDYSANDA 2159612022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
UBIANDA 2102232020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
UBIANDA 2102182020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
NOVAST LABSANDA 20835720192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DESMOPRESSIN ACETATE
AM REGENTANDA 0913742019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Discontinued —
DESMOPRESSIN ACETATE
ABHAI LLCANDA 21037120192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
ZYDUS PHARMSANDA 0913452017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01MG/SPRAY SPRAY, METERED NASAL Rx AB
DESMOPRESSIN ACETATE
SAGENT PHARMS INCANDA 2046952017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
SAGENT PHARMS INCANDA 2047512017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP
DESMOPRESSIN ACETATE
HERITAGE PHARMAANDA 20788020172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DESMOPRESSIN ACETATE
GLENMARK PHARMS LTDANDA 20183120152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
DESMOPRESSIN ACETATE
NATCO PHARMA USAANDA 20065320142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
SUN PHARMANDA 0782712013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01MG/SPRAY SPRAY, METERED NASAL Discontinued —
DESMOPRESSIN ACETATE
SUN PHARM INDS LTDANDA 0912802013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Discontinued —
DESMOPRESSIN ACETATE
SUN PHARM INDSANDA 0772122012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION NASAL Discontinued —
DESMOPRESSIN ACETATE
APOTEXANDA 07741420062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
DESMOPRESSIN ACETATE
IMPAX LABS INCANDA 07712220062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
DESMOPRESSIN ACETATE
ACTAVIS LABS FL INCANDA 07647020052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)RS
APOTEXANDA 0767032005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01MG/SPRAY SPRAY, METERED NASAL Rx AB
DESMOPRESSIN ACETATE
HOSPIRAANDA 0752202000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Discontinued —
DESMOPRESSIN ACETATE
BEDFORDANDA 0745752000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Discontinued —
DESMOPRESSIN ACETATE PRESERVATIVE FREE
BEDFORDANDA 0745742000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Discontinued —
DESMOPRESSIN ACETATERS
BAUSCHANDA 0748301999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01MG/SPRAY SPRAY, METERED NASAL Rx AB
DESMOPRESSIN ACETATE
MEITHEALANDA 0748881997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01MG/SPRAY	SPRAY, METERED	NASAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG/ML	INJECTABLE	INJECTION	Rx	AP

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11963995	May 21, 2029	in 2 yr 10 mo	U-2327
11020448	May 21, 2029	in 2 yr 10 mo	U-2327
10137167	May 21, 2029	in 2 yr 10 mo	U-2327
9974826	Apr 13, 2030	in 3 yr 9 mo	U-2326
11419914	Jun 15, 2030	in 3 yr 11 mo	U-3431
12090190	Jun 15, 2030	in 3 yr 11 mo	ProductU-4003
9539302	Jun 15, 2030	in 3 yr 11 mo	Product
12343372	Apr 03, 2044	in 17 yr 11 mo	ProductU-4432
12214010	Apr 03, 2044	in 17 yr 11 mo	Product

Approval history

FDA approval span

First approval

Mar 30, 1984

43 yr ago

Most recent approval

Feb 27, 2026

6 mo ago

Approvals span 1984–2026 across 38 FDA applications.

Brand (NDA) 1026%

Generic (ANDA) 2874%

Desmopressin acetate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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