Home / Generic availability / Desmopressin
When will generic Desmopressin be available?
Based on the patents and exclusivity the FDA lists today, generic desmopressin cannot be marketed in the United States before 2044-04-03, when the last listed protection expires.
Patents listed with the FDA
9 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 11020448 | 2029-05-21 | method of use | NOCDURNA |
| 11963995 | 2029-05-21 | method of use | NOCDURNA |
| 10137167 | 2029-05-21 | method of use | NOCDURNA |
| 9974826 | 2030-04-13 | method of use | NOCDURNA |
| 11419914 | 2030-06-15 | method of use | NOCTIVA |
| 12090190 | 2030-06-15 | drug product | NOCTIVA |
| 9539302 | 2030-06-15 | drug product | NOCTIVA |
| 12214010 | 2044-04-03 | drug product | DESMODA |
| 12343372 | 2044-04-03 | drug product | DESMODA |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| DDAVP, DDAVP (NEEDS NO REFRIGERATION) | Brand (NDA) | FERRING PHARMACEUTICALS INC | 1989-02-06 | reference listed drug |
| DDAVP | Brand (NDA) | J MOLNER HOLDINGS INC | 1984-03-30 | reference listed drug, reference standard |
| CONCENTRAID | Brand (NDA) | FERRING PHARMACEUTICALS INC | 1990-12-26 | |
| DDAVP | Brand (NDA) | FERRING PHARMACEUTICALS INC | 1995-09-06 | reference listed drug, reference standard |
| STIMATE, STIMATE (NEEDS NO REFRIGERATION) | Brand (NDA) | FERRING PHARMACEUTICALS INC | 1994-03-07 | reference listed drug |
| MINIRIN | Brand (NDA) | FERRING PHARMACEUTICALS INC | 2002-09-16 | reference listed drug |
| DESMOPRESSIN ACETATE | Brand (NDA) | FERRING PHARMACEUTICALS INC | 2008-05-08 | |
| NOCDURNA | Brand (NDA) | FERRING PHARMACEUTICALS INC | 2018-06-21 | reference listed drug |
| DESMOPRESSIN ACETATE PRESERVATIVE FREE | Generic (ANDA) | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2000-02-18 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2000-02-18 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | BAUSCH HEALTH US LLC | 1999-01-25 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 1997-10-15 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | HOSPIRA INC | 2000-08-28 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | ACTAVIS LABORATORIES FL INC | 2005-07-01 | |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | Generic (ANDA) | APOTEX INC | 2005-01-27 | reference standard |
| DESMOPRESSIN ACETATE | Generic (ANDA) | IMPAX LABORATORIES INC | 2006-01-25 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2012-04-12 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | APOTEX INC | 2006-03-07 | |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2013-12-23 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2013-01-25 | |
| DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | Generic (ANDA) | ZYDUS PHARMACEUTICALS USA INC | 2017-10-03 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | AMERICAN REGENT INC | 2019-02-14 | |
| DESMOPRESSIN ACETATE | Generic (ANDA) | NATCO PHARMA USA LLC | 2014-06-27 | |
| NOCTIVA | Brand (NDA) | ACERUS PHARMACEUTICALS USA LLC | 2017-03-03 | reference listed drug |
What a generic Desmopressin would have to match
How it is supplied
HOW SUPPLIED Desmopressin Acetate Tablets 0.1 mg are available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.1” on the other side. They are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-721‐21 Desmopressin Acetate Tablets 0.2 mg are available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.2” on the other side. They are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-732‐21 Store 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2025-11-13.
Recalls involving Desmopressin
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Apotex Corp. | FL | Class II | 2026-04-08 | Defective container: defect in a batch of bottle caps, specifically in |
| RemedyRepack Inc. | PA | Class II | 2022-12-05 | Subpotent Drug: repackaged product was recalled by the manufacturer fo |
| Heritage Pharmaceuticals Inc | NJ | Class II | 2022-11-23 | Subpotent Drug |
| Glenmark Pharmaceuticals Inc., USA | NJ | Class II | 2022-06-29 | CGMP Deviations |
| Teva Pharmaceuticals USA | NJ | Class II | 2021-02-10 | Lack of Assurance of Sterility: manufacturing areas for the recalled p |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Triptorelinprotection runs to June 2029
- Afamelanotideprotection runs to January 2033
- Bremelanotideprotection runs to November 2033
- Vasopressinprotection runs to January 2035
- Liraglutideprotection runs to January 2037
Frequently asked questions
When will generic Desmopressin be available?
Based on the patents and exclusivity the FDA lists today, generic desmopressin cannot be marketed in the United States before 2044-04-03, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Desmopressin clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book