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, 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-seven NDAs.

The generic ingredient in DESMOPRESSIN ACETATE is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-eight 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:	24
NDAs:	27
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	10
Patent Applications:	766
Formulation / Manufacturing:	see details
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
Genentech, Inc.	Phase 4
Indiana Hemophilia &Thrombosis Center, 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
Novast Labs	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	208357-002	Jun 6, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	077122-002	Jan 25, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	076703-001	Jan 27, 2005	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco Pharma Usa	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	200653-001	Jun 27, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091374-001	Feb 14, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-002	May 8, 2008	⤷ Try a Trial	⤷ Try a Trial
>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
Taiwan	I268782		⤷ Try a Trial
New Zealand	544104	Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005011640		⤷ Try a Trial
Norway	327328		⤷ Try a Trial
Poland	379704	Środek farmaceutyczny jako stała postać dawkowana i sposób jego wytwarzania (PHARMACEUTICAL DESMOPRESSIN COMPOSITION AS SOLID DOSAGE FORM AND METHOD FOR MANUFACTURING THEREOF)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3225249	2019C/520	Belgium	⤷ Try a Trial	PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
2712622	122017000006	Germany	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
3225249	CA 2019 00023	Denmark	⤷ Try a Trial	PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504
2712622	C02712622/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description