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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 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, Alyvant, 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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Desmopressin acetate has one hundred and ninety-nine patent family members in thirty-five countries.
There are twenty drug master file entries for desmopressin acetate. Twenty-three suppliers are listed for this compound.
Summary for DESMOPRESSIN ACETATE
| International Patents: | 199 |
| US Patents: | 13 |
| Tradenames: | 11 |
| Applicants: | 22 |
| NDAs: | 32 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,027 |
| Formulation / Manufacturing: | see details |
| 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 |
Recent Clinical Trials for DESMOPRESSIN ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Indiana Hemophilia &Thrombosis Center, Inc. | Phase 4 |
| Genentech, Inc. | Phase 4 |
| Ahmed talaat ahmed aly | Phase 2 |
Pharmacology for DESMOPRESSIN ACETATE
| Drug Class | Factor VIII Activator Vasopressin Analog |
| Physiological Effect | Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration |
Paragraph IV (Patent) Challenges for DESMOPRESSIN ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| 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 | |
| DDAVP | SOLUTION;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 | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Alyvant | NOCTIVA | desmopressin acetate | SPRAY, METERED;NASAL | 201656-001 | Mar 3, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Ferring Pharms Inc | NOCDURNA | desmopressin acetate | TABLET;SUBLINGUAL | 022517-001 | Jun 21, 2018 | RX | 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 | desmopressin acetate | TABLET;ORAL | 019955-002 | Sep 6, 1995 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP | desmopressin acetate | TABLET;ORAL | 019955-001 | Sep 6, 1995 | Start Trial | Start Trial |
| Ferring Pharms Inc | DDAVP (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 017922-003 | Aug 7, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DESMOPRESSIN ACETATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2712622 | Start Trial |
| Taiwan | 200400054 | Start Trial |
| Japan | 6166320 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DESMOPRESSIN ACETATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 300983 | Netherlands | Start Trial | PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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