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Last Updated: October 20, 2021

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Desmopressin acetate - Generic Drug Details

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What are the generic 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, 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, Roivant, Abhai Llc, Actavis Labs Fl Inc, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Mylan, and Novast Labs, and is included in thirty-two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desmopressin acetate has two hundred patent family members in thirty-five countries.

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

Drug Prices for desmopressin acetate

See drug prices for desmopressin acetate

Recent Clinical Trials for desmopressin acetate

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

SponsorPhase
Indiana Hemophilia &Thrombosis Center, Inc.Phase 4
Genentech, Inc.Phase 4
Ahmed talaat ahmed alyPhase 2

See all desmopressin acetate clinical trials

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

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
Sun Pharm Inds DESMOPRESSIN ACETATE desmopressin acetate SOLUTION;NASAL 077212-001 Apr 12, 2012 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novast Labs DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 208357-001 Jun 6, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ferring DESMOPRESSIN ACETATE desmopressin acetate TABLET;ORAL 021795-001 May 8, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 desmopressin acetate INJECTABLE;INJECTION 018938-002 Apr 25, 1995 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ferring Pharms Inc DDAVP (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 017922-003 Aug 7, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ferring Pharms Inc DDAVP (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 017922-003 Aug 7, 1996 ⤷  Free Forever Trial ⤷  Free Forever 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 C02712622/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
2712622 PA2017001 Lithuania ⤷  Free Forever 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 300983 Netherlands ⤷  Free Forever Trial PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Colorcon
McKesson
Express Scripts
Dow

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