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Desmopressin acetate - Generic Drug Details

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What are the generic drug sources for desmopressin acetate and what is the scope of patent protection?

Desmopressin acetate is the generic ingredient in eleven branded drugs marketed by Ferring Pharms Inc, Am Regent, Bedford, Hospira, Sagent Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, UBI, Ferring, Sun Pharm Inds, Bausch And Lomb, Apotex Inc, Sun Pharm, Zydus Pharms, Roivant, Abhai Llc, Actavis Labs Fl Inc, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Mylan, and Novast Labs, and is included in thirty-two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desmopressin acetate has two hundred patent family members in thirty-five countries.

There are twenty drug master file entries for desmopressin acetate. Twenty-five suppliers are listed for this compound.

Summary for desmopressin acetate

International Patents:	200
US Patents:	14
Tradenames:	11
Applicants:	22
NDAs:	32
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	7
Patent Applications:	1,093
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for desmopressin acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for desmopressin acetate
What excipients (inactive ingredients) are in desmopressin acetate?	desmopressin acetate excipients list
DailyMed Link:	desmopressin acetate at DailyMed

See drug prices for desmopressin acetate

Recent Clinical Trials for desmopressin acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indiana Hemophilia &Thrombosis Center, Inc.	Phase 4
Genentech, Inc.	Phase 4
Ahmed talaat ahmed aly	Phase 2

See all desmopressin acetate clinical trials

Pharmacology for desmopressin acetate

Drug Class	Factor VIII Activator Vasopressin Analog
Physiological Effect	Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Anatomical Therapeutic Chemical (ATC) Classes for desmopressin acetate

H01BA	Vasopressin and analogues
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for DESMOPRESSIN ACETATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
DDAVP	SOLUTION;NASAL	desmopressin acetate	017922
DDAVP	TABLET;ORAL	desmopressin acetate	019955
DDAVP	SPRAY, METERED;NASAL	desmopressin acetate	017922
DDAVP (NEEDS NO REFRIGERATION)	SPRAY, METERED;NASAL	desmopressin acetate	017922
DDAVP	INJECTABLE;INJECTION	desmopressin acetate	018938

US Patents and Regulatory Information for desmopressin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roivant	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995	AB	RX	Yes	Yes
Mylan	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	200653-002	Jun 27, 2014		DISCN	No	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		RX	Yes	Yes			Y
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		RX	Yes	Yes

Expired US Patents for desmopressin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-001	Sep 6, 1995
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996
Ferring Pharms Inc	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-001	Mar 30, 1984
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	SOLUTION;NASAL	017922-001	Approved Prior to Jan 1, 1982

International Patents for desmopressin acetate

Country	Patent Number	Estimated Expiration
Portugal	2712622
United Kingdom	0210397
European Patent Office	3225250
China	1319592
World Intellectual Property Organization (WIPO)	2010075266

Supplementary Protection Certificates for desmopressin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
2712622	122017000006	Germany		PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
2712622	PA2017001,C2712622	Lithuania		PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
2712622	LUC00015	Luxembourg		PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101