Adempas is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2013 to 2022. Out of these, 3 drug patents are active and 1 has expired. Adempas's patents have been open to challenges since 08 October, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 18, 2034. Details of Adempas's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11203593 | Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate |
Feb, 2034
(8 years from now) | Active |
| US10662188 | Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate |
Feb, 2034
(8 years from now) | Active |
| US7173037 | Carbamate-substituted pyrazolopyridines |
Dec, 2026
(1 year, 1 month from now) | Active |
| US6743798 | Substituted pyrazole derivatives condensed with six-membered heterocyclic rings |
Jul, 2019
(6 years 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 Adempas's patents.
Latest Legal Activities on Adempas's Patents
Given below is the list of recent legal activities going on the following patents of Adempas.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Nov, 2023 | US10662188 |
| Recordation of Patent Grant Mailed
Critical | 21 Dec, 2021 | US11203593 |
| Patent Issue Date Used in PTA Calculation
Critical | 21 Dec, 2021 | US11203593 |
| Email Notification
Critical | 02 Dec, 2021 | US11203593 |
| Issue Notification Mailed
Critical | 01 Dec, 2021 | US11203593 |
| Dispatch to FDC | 16 Nov, 2021 | US11203593 |
| Application Is Considered Ready for Issue
Critical | 16 Nov, 2021 | US11203593 |
| Issue Fee Payment Received
Critical | 15 Nov, 2021 | US11203593 |
| Issue Fee Payment Verified
Critical | 15 Nov, 2021 | US11203593 |
| Supplemental Papers - Oath or Declaration | 24 Sep, 2021 | US11203593 |
FDA has granted several exclusivities to Adempas. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Adempas, 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
Adempas.
Exclusivity Information
Adempas holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Adempas's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 08, 2018 |
| Orphan Drug Exclusivity(ODE) | Oct 08, 2020 |
| Orphan Drug Exclusivity(ODE-53) | Oct 08, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Adempas 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 Adempas's family patents as well as insights into
ongoing legal events
on those patents.
Adempas's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Adempas's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 18, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adempas Generic API suppliers:
Riociguat is the generic name for the brand Adempas. 1 company has already filed for the generic of Adempas. Check out the entire list of companies who have already received approval for Adempas's generic
How can I launch a generic of Adempas before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adempas's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adempas's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Adempas -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg | 10 Oct, 2017 | 3 | 01 Sep, 2022 | 04 Dec, 2026 | Deferred |
About Adempas
Adempas is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) to improve exercise capacity and WHO functional class, and delay clinical worsening. Adempas uses Riociguat as an active ingredient. Adempas was launched by Bayer Hlthcare in 2013.
Approval Date:
Adempas was approved by FDA for market use on 08 October, 2013.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Adempas is 08 October, 2013, its NCE-1 date is estimated to be 08 October, 2017.
Active Ingredient:
Adempas uses Riociguat as the active ingredient. Check out other Drugs and Companies using Riociguat ingredient
Treatment:
Adempas is used for treating chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) to improve exercise capacity and WHO functional class, and delay clinical worsening.
Dosage:
Adempas is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 1.5MG | TABLET | Prescription | ORAL |