Noctiva Patent Expiration

Noctiva is a drug owned by Acerus Pharmaceuticals Usa Llc. It is protected by 6 US drug patents filed from 2017 to 2024. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 15, 2030. Details of Noctiva's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11419914 Safe desmopressin administration
Jun, 2030

(5 years from now)

Active
US12090190 Safe desmopressin administration
Jun, 2030

(5 years from now)

Active
US9539302 Safe desmopressin administration
Jun, 2030

(5 years from now)

Active
US7799761 Pharmaceutical compositions including low dosages of desmopressin
Sep, 2024

(a month ago)

Expired
US7579321 Pharmaceutical compositions including low dosages of desmopressin
May, 2023

(1 year, 6 months ago)

Expired
US7405203 Pharmaceutical compositions including low dosages of desmopressin
May, 2023

(1 year, 6 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Noctiva's patents.

Given below is the list of recent legal activities going on the following patents of Noctiva.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 05 Jul, 2024 US9539302
Patent Issue Date Used in PTA Calculation 23 Aug, 2022 US11419914
Recordation of Patent Grant Mailed 23 Aug, 2022 US11419914
Email Notification 04 Aug, 2022 US11419914
Issue Notification Mailed 03 Aug, 2022 US11419914
Mailing Corrected Notice of Allowability 15 Jul, 2022 US11419914
Email Notification 15 Jul, 2022 US11419914
Corrected Notice of Allowability 12 Jul, 2022 US11419914
Pubs Case Remand to TC 11 Jul, 2022 US11419914
Dispatch to FDC 06 Jul, 2022 US11419914


FDA has granted several exclusivities to Noctiva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Noctiva, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Noctiva.

Exclusivity Information

Noctiva holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Noctiva's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 03, 2020

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Several oppositions have been filed on Noctiva's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Noctiva's generic, the next section provides detailed information on ongoing and past EP oppositions related to Noctiva patents.

Noctiva's Oppositions Filed in EPO

Noctiva has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 12, 2018, by Ferring B.V.. This opposition was filed on patent number EP10790053A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP17168865A Aug, 2020 Ferring B.V. Revoked
EP09796558A May, 2019 Ferring B.V. Patent maintained as amended
EP10790053A Mar, 2018 Ferring B.V. Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Noctiva is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Noctiva's family patents as well as insights into ongoing legal events on those patents.

Noctiva's Family Patents

Noctiva has patent protection in a total of 32 countries. It's US patent count contributes only to 21.8% of its total global patent coverage. 12 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Noctiva.

Family Patents

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Generic Launch

Generic Release Date:

Noctiva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 15, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Noctiva Generic API suppliers:

Desmopressin Acetate is the generic name for the brand Noctiva. 24 different companies have already filed for the generic of Noctiva, with Abhai Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Noctiva's generic

Alternative Brands for Noctiva

Noctiva which is used for treating nocturia (frequent urination at night) in adults with nocturnal polyuria by administering intranasal desmopressin., has several other brand drugs using the same active ingredient (Desmopressin Acetate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.


Apart from brand drugs containing the same ingredient, some generics have also been filed for Desmopressin Acetate, Noctiva's active ingredient. Check the complete list of approved generic manufacturers for Noctiva





About Noctiva

Noctiva is a drug owned by Acerus Pharmaceuticals Usa Llc. It is used for treating nocturia (frequent urination at night) in adults with nocturnal polyuria by administering intranasal desmopressin. Noctiva uses Desmopressin Acetate as an active ingredient. Noctiva was launched by Acerus Pharms in 2017.

Approval Date:

Noctiva was approved by FDA for market use on 03 March, 2017.

Active Ingredient:

Noctiva uses Desmopressin Acetate as the active ingredient. Check out other Drugs and Companies using Desmopressin Acetate ingredient

Treatment:

Noctiva is used for treating nocturia (frequent urination at night) in adults with nocturnal polyuria by administering intranasal desmopressin.

Dosage:

Noctiva is available in spray, metered form for nasal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.00166MG/SPRAY SPRAY, METERED Discontinued NASAL
0.00083MG/SPRAY SPRAY, METERED Discontinued NASAL