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, Dr Reddys, Gland Pharma Ltd, Hospira, Sagent Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, UBI, Ferring, Sun Pharm Inds, Bausch, Apotex Inc, Sun Pharm, Zydus Pharms, Acerus Pharms, Abhai Llc, Actavis Labs Fl Inc, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Mylan, and Novast Labs, and is included in thirty-four NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for desmopressin acetate

International Patents:	205
US Patents:	13
Tradenames:	11
Applicants:	24
NDAs:	34
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	10
Patent Applications:	1,195
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
Cairo University	N/A
Indiana Hemophilia &Thrombosis Center, Inc.	Phase 4
Genentech, Inc.	Phase 4

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

US Patents and Regulatory Information for desmopressin acetate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bedford	DESMOPRESSIN ACETATE PRESERVATIVE FREE	desmopressin acetate	INJECTABLE;INJECTION	074574-001	Feb 18, 2000		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sagent Pharms Inc	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	204751-001	Aug 22, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Glenmark Pharms Ltd	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	201831-001	May 28, 2015	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bedford	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	074575-001	Feb 18, 2000		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for desmopressin acetate

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

International Patents for desmopressin acetate

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Country	Patent Number	Title	Estimated Expiration
Portugal	2712622		See Plans and Pricing
Denmark	3225250		See Plans and Pricing
Taiwan	I315202		See Plans and Pricing
Portugal	3679941		See Plans and Pricing
Israel	213699	מכשיר למתן תוך-אפי של דזמופרסין (Intranasal desmopressin dispenser)	See Plans and Pricing
Denmark	2550007		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for desmopressin acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3225249	300983	Netherlands	See Plans and Pricing	PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
2712622	LUC00015	Luxembourg	See Plans and Pricing	PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
3225249	2019C/520	Belgium	See Plans and Pricing	PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
2712622	122017000006	Germany	See Plans and Pricing	PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504
2712622	C02712622/01	Switzerland	See Plans and Pricing	PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
3225249	CA 2019 00023	Denmark	See Plans and Pricing	PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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