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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs8 inactive

10 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

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

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