DESMOPRESSIN ACETATE Drug Patent Profile

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Desmopressin Acetate is a drug marketed by Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Sun Pharm Inds, Bausch, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, Novast Labs, Apotex, Sun Pharm, and Zydus Pharms. and is included in twenty-eight NDAs.

The generic ingredient in DESMOPRESSIN ACETATE is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

A generic version of DESMOPRESSIN ACETATE was approved as desmopressin acetate by MEITHEAL on October 15^th, 1997.

US Patents:	0
Applicants:	25
NDAs:	28
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	10
Patent Applications:	2,880
Drug Prices:	Drug price information 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

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

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

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

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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
Natco Pharma Usa	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	200653-002	Jun 27, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	207880-002	May 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	208357-001	Jun 6, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	077122-001	Jan 25, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091374-001	Feb 14, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	076470-002	Jul 1, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-002	May 8, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-001	May 8, 2008	⤷ Sign Up	⤷ Sign Up
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-002	May 8, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering DESMOPRESSIN ACETATE around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1072009	Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof.	⤷ Sign Up
South Africa	200600018	Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof	⤷ Sign Up
New Zealand	544104	Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof	⤷ Sign Up
Russian Federation	2005141230	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЕСМОПРЕССИНА В ВИДЕ ТВЕРДОЙ ДОЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЫ И СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ	⤷ Sign Up
Taiwan	200509995	Pharmaceutical composition as solid dosage form and method for manufacturing thereof	⤷ Sign Up
Slovenia	1500390		⤷ Sign Up
Taiwan	I268782		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	LUC00015	Luxembourg	⤷ Sign Up	PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
2712622	C02712622/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
3225249	300983	Netherlands	⤷ Sign Up	PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
2712622	122017000006	Germany	⤷ Sign Up	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	2019C/520	Belgium	⤷ Sign Up	PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
3225249	CA 2019 00023	Denmark	⤷ Sign Up	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