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STIMATE

NDA

DESMOPRESSIN ACETATE | N020355 | FERRING PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Buchanan Ingersoll & Rooney PC - Citizen Petition FDA-2010-P-0331 · 2 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition on June 22, 2010, requesting that the FDA Commissioner determine whether non-refrigerated Stimate (1.5 mg/mL desmopressin acetate nasal spray), approved under NDA number 20355, was voluntarily discontinued from the U.S. market for safety or	505(q)	2010-06-28	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

56 trials from ClinicalTrials.gov, 43 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery NCT01994330	Phase 4	Completed	Pontificia Universidad Catolica de Chile	13	2009-06 → 2010-02
Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients NCT01223937	Phase 3	Completed	Ferring Pharmaceuticals	268	2010-11 → 2011-11
Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study NCT01435083	Phase 4	Completed	University Hospital, Ghent	50	2011-11 → 2013-07
Characterization of Laboratory Response to DDAVP in Adult Hemophilia A Carriers NCT02506023	Phase 1	Completed	Emory University	2	2015-07 → 2018-06-15
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers NCT04103034	Phase 1	Completed	Band Therapeutics	112	2019-10-07 → 2020-09-14
Treatment of Supine Hypertension in Autonomic Failure NCT00223717	Phase 1	Completed	Vanderbilt University	152	2001-01 → 2017-01
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis NCT01078753	Phase 3	Completed	Ferring Pharmaceuticals	89	2010-01 → 2010-09
Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women NCT01684800	Phase 2	Completed	Ferring Pharmaceuticals	178	2012-09 → 2013-06
Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction NCT00816127	N/A	Completed	Icahn School of Medicine at Mount Sinai	36	2003-10 → 2007-05
Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage NCT03696121	Phase 2	Completed	University of Nottingham	54	2019-04-01 → 2022-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain12 active DMFs9 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

POLYPEPTIDE LABORATORIES SWEDEN ABDESMOPRESSIN

DMF 83961990

BACHEM AMERICAS INCDESMOPRESSIN ACETATE

DMF 99511992

ASPEN OSS BVDESMOPRESSIN

DMF 101751993

TAPI NL BVDESMOPRESSIN ACETATE USP

DMF 169472003

BCN PEPTIDES SADESMOPRESSIN ACETATE

DMF 193342006

SCINOPHARM TAIWAN LTDDESMOPRESSIN ACETATE

DMF 223242008

PIRAMAL PHARMA LTDDESMOPRESSIN ACETATE

DMF 228712009

POLYPEPTIDE LABORATORIES SWEDEN ABDESMOPRESSIN ACETATE DRUG SUBSTANCE

DMF 236762010

AURO PEPTIDES LTDDESMOPRESSIN ACETATE USP

DMF 302332016

HYBIO PHARMACEUTICAL CO LTDDESMOPRESSIN ACETATE

DMF 318892017

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDDESMOPRESSIN ACETATE

DMF 377992023

SHILPA PHARMA LIFESCIENCES LTDDESMOPRESSIN ACETATE USP

DMF 435222026

LONZA BRAINE SAInactiveDESMOPRESSIN ACETATE

DMF 74931988

IAF BIOCHEM INTERNATIONAL INCInactiveDESMOPRESSIN

DMF 80441989

DIOSYNTH BVInactiveDESMOPRESSIN

DMF 80931989

CARLBIOTECH LTD ASInactiveDESMOPRESSIN ACETATE

DMF 90531991

SPECGX LLCInactiveDESMOPRESSIN

DMF 93861991

BACHEM FEINCHEMIKALIEN AGInactiveDESMOPRESSIN ACETATE

DMF 102831993

BACHEM INCInactiveDESMOPRESSIN

DMF 143621999

SINOPEP PHARMACEUTICAL INCInactiveDESMOPRESSIN ACETATE, NON-STERILE DRUG SUBSTANCE

DMF 207522007

MYLAN LABORATORIES LTDInactiveDESMOPRESSIN ACETATE USP

DMF 256522011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2013	SUPPL -20	View Letter (PDF)
May 28, 2013	SUPPL -17	View Letter (PDF)
Sep 21, 2011	SUPPL -13	View Letter (PDF)
Nov 8, 2007	SUPPL -7	View Letter (PDF)
Aug 21, 2002	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.15MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Mar 7, 1994

No patent or exclusivity listings for this strength.

#002 — 0.15MG/SPRAY

RLD

0 patents0 exclusivities▾

SPRAY, METERED;NASAL | Approved: Oct 24, 2007