Nocdurna is a drug owned by Ferring Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2018 to 2024. Out of these, 4 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 13, 2030. Details of Nocdurna'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9919025 | Pharmaceutical formulations of desmopressin |
May, 2023
(1 year, 2 months ago) |
Expired
|
| US9220747 | Methods using desmopressin acetate in orodispersible form |
May, 2023
(1 year, 2 months ago) |
Expired
|
| US10307459 | Pharmaceutical formulations of desmopressin |
May, 2023
(1 year, 2 months ago) |
Expired
|
| US9504647 | Pharmaceutical formulations of desmopressin |
May, 2023
(1 year, 2 months ago) |
Expired
|
| US7947654 | Pharmaceutical formulations |
Dec, 2023
(6 months ago) |
Expired
|
| US8802624 | Methods of treatment using orodispersible desmopressin pharmaceutical formulations |
Dec, 2023
(6 months ago) |
Expired
|
| US7560429 | Orodispersible dosage forms of desmopressin acetate |
Feb, 2024
(5 months ago) |
Expired
|
| US11963995 | Methods comprising desmopressin |
May, 2029
(4 years from now) | Active |
| US11020448 | Methods comprising desmopressin |
May, 2029
(4 years from now) | Active |
| US10137167 | Methods comprising desmopressin |
May, 2029
(4 years from now) | Active |
| US9974826 | Methods comprising desmopressin |
Apr, 2030
(5 years from now) | Active |
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 Nocdurna's patents.
Latest Legal Activities on Nocdurna's Patents
Given below is the list of recent legal activities going on the following patents of Nocdurna.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2023 | US9220747 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Nov, 2022 | US10307459 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Nov, 2022 | US7947654 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 May, 2022 | US10137167 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Feb, 2022 | US8802624 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Nov, 2021 | US9974826 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Sep, 2021 | US9919025 |
| Patent Issue Date Used in PTA Calculation | 01 Jun, 2021 | US11020448 |
| Recordation of Patent Grant Mailed | 01 Jun, 2021 | US11020448 |
| Email Notification | 14 May, 2021 | US11020448 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Nocdurna and ongoing litigations to help you estimate the early arrival of Nocdurna generic.
Nocdurna's Litigations
Nocdurna has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 16, 2015, against patent number US9974826. The petitioner , challenged the validity or infringement of this patent, with Bjarke Mimer Klein et al as the respondent. Click below to track the latest information on how companies are challenging Nocdurna's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9974826 | April, 2015 | Decision | Bjarke Mimer Klein et al | |
FDA has granted some exclusivities to Nocdurna. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nocdurna, 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 Nocdurna.
Exclusivity Information
Nocdurna holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Nocdurna's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 21, 2021 |
Several oppositions have been filed on Nocdurna'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 Nocdurna's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nocdurna patents.
Nocdurna's oppositions filed in EPO
Nocdurna has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 11, 2014, by Gebro Pharma Gmbh. This opposition was filed on patent number EP09751584A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09751584A | Nov, 2014 | Gebro Pharma GmbH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Nocdurna 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 Nocdurna's family patents as well as insights into ongoing legal events on those patents.
Nocdurna's family patents
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Generic Launch
Generic Release Date:
Nocdurna's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 13, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nocdurna Generics:
Desmopressin Acetate is the generic name for the brand Nocdurna. 24 different companies have already filed for the generic of Nocdurna, with Abhai Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nocdurna's generic
About Nocdurna
Nocdurna is a drug owned by Ferring Pharmaceuticals Inc. It is used for treating nocturia in adults with nocturnal polyuria by monitoring serum sodium concentration. Nocdurna uses Desmopressin Acetate as an active ingredient. Nocdurna was launched by Ferring Pharms Inc in 2018.
Market Authorisation Date:
Nocdurna was approved by FDA for market use on 21 June, 2018.
Active Ingredient:
Nocdurna uses Desmopressin Acetate as the active ingredient. Check out other Drugs and Companies using Desmopressin Acetate ingredient
Treatment:
Nocdurna is used for treating nocturia in adults with nocturnal polyuria by monitoring serum sodium concentration.
Dosage:
Nocdurna is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.0277MG | TABLET | Discontinued | SUBLINGUAL |
| 0.0553MG | TABLET | Discontinued | SUBLINGUAL |