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Last Updated: August 7, 2020

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DESMOPRESSIN ACETATE Drug Profile

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Which patents cover Desmopressin Acetate, and what generic alternatives are available?

Desmopressin Acetate is a drug marketed by Am Regent, Bedford, Hospira, Sagent Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms Usa, UBI, Sun Pharm Inds, Bausch And Lomb, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Mylan, Novast Labs, Sun Pharm, and Zydus Pharms. and is included in twenty-three NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Desmopressin Acetate

A generic version of DESMOPRESSIN ACETATE was approved as desmopressin acetate by TEVA PHARMS USA on October 15th, 1997.

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Drug patent expirations by year for DESMOPRESSIN ACETATE
Drug Prices for DESMOPRESSIN ACETATE

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Recent Clinical Trials for DESMOPRESSIN ACETATE

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
University Hospitals Cleveland Medical CenterPhase 2
Teva Pharmaceuticals USAPhase 1

See all DESMOPRESSIN ACETATE clinical trials

Paragraph IV (Patent) Challenges for DESMOPRESSIN ACETATE
Tradename Dosage Ingredient NDA Submissiondate
DDAVP INJECTABLE;INJECTION desmopressin acetate 018938
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

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
Bedford DESMOPRESSIN ACETATE PRESERVATIVE FREE desmopressin acetate INJECTABLE;INJECTION 074574-001 Feb 18, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Novast Labs DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 208357-002 Jun 6, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 076703-001 Jan 27, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Am Regent DESMOPRESSIN ACETATE desmopressin acetate INJECTABLE;INJECTION 091374-001 Feb 14, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Ferring DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 021795-002 May 8, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 077122-002 Jan 25, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DESMOPRESSIN ACETATE desmopressin acetate INJECTABLE;INJECTION 074888-001 Oct 15, 1997 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DESMOPRESSIN ACETATE

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

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Serving leading biopharmaceutical companies globally:

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Colorcon
Baxter
Johnson and Johnson
Mallinckrodt
Medtronic

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