DESMOPRESSIN ACETATE - Generic Drug Details

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What are the generic drug sources for desmopressin acetate and what is the scope of freedom to operate?

Desmopressin acetate is the generic ingredient in eleven branded drugs marketed by Ferring Pharms Inc, Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Ferring, Sun Pharm Inds, Bausch, Apotex, Sun Pharm, Zydus Pharms, Acerus Pharms, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, and Novast Labs, and is included in thirty-six NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for DESMOPRESSIN ACETATE

International Patents:	209
US Patents:	8
Tradenames:	11
Applicants:	27
NDAs:	36
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	10
Patent Applications:	6,920
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
Genentech, Inc.	Phase 4
Indiana Hemophilia &Thrombosis Center, 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
Sagent Pharms Inc	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	204751-001	Aug 22, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	201831-002	May 28, 2015	AB	RX	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
Heritage Pharma	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	207880-001	May 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
>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
Russian Federation	2012101619	БЕЗОПАСНОЕ ПРИМЕНЕНИЕ ДЕСМОПРЕССИНА	⤷ Sign Up
Poland	2712622		⤷ Sign Up
Eurasian Patent Organization	201170873	БЕЗОПАСНОЕ ВВЕДЕНИЕ ДЕСМОПРЕССИНА	⤷ Sign Up
Spain	2773694		⤷ Sign Up
Poland	3225250		⤷ Sign Up
China	1319592		⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
3225249	2019C/520	Belgium	⤷ Sign Up	PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND 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
2712622	LUC00015	Luxembourg	⤷ Sign Up	PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
2712622	PA2017001	Lithuania	⤷ Sign Up	PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
2712622	C02712622/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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