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Last Updated: August 9, 2020

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

Desmopressin acetate has one hundred and ninety-seven patent family members in thirty-five countries.

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

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 (NEEDS NO REFRIGERATION) SPRAY, METERED;NASAL desmopressin acetate 017922
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

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
Ferring Pharms Inc STIMATE desmopressin acetate SPRAY, METERED;NASAL 020355-001 Mar 7, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Ferring Pharms Inc DDAVP desmopressin acetate INJECTABLE;INJECTION 018938-002 Apr 25, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Bedford DESMOPRESSIN ACETATE desmopressin acetate INJECTABLE;INJECTION 074575-001 Feb 18, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Ferring MINIRIN desmopressin acetate SPRAY, METERED;NASAL 021333-001 Sep 16, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Alyvant NOCTIVA desmopressin acetate SPRAY, METERED;NASAL 201656-002 Mar 3, 2017 DISCN Yes 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

Expired US Patents for desmopressin acetate

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   Start Trial   Start Trial
Ferring Pharms Inc DDAVP desmopressin acetate SPRAY, METERED;NASAL 017922-002 Feb 6, 1989   Start Trial   Start Trial
Ferring Pharms Inc DDAVP desmopressin acetate SOLUTION;NASAL 017922-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ferring Pharms Inc DDAVP desmopressin acetate TABLET;ORAL 019955-002 Sep 6, 1995   Start Trial   Start Trial
Ferring Pharms Inc DDAVP desmopressin acetate INJECTABLE;INJECTION 018938-001 Mar 30, 1984   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for desmopressin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
3225249 300983 Netherlands   Start Trial PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
3225249 2019C/520 Belgium   Start Trial PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
2712622 PA2017001 Lithuania   Start Trial PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
Moodys
Colorcon

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