Mycapssa is a drug owned by Chiesi Farmaceutici Spa. It is protected by 16 US drug patents filed from 2020 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 28, 2040. Details of Mycapssa'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). | |||
| US11141457 | Oral octreotide therapy and contraceptive methods |
Dec, 2040
(15 years from now) | Active |
| US11890316 | Oral octreotide therapy and contraceptive methods |
Dec, 2040
(15 years from now) | Active |
| US12251418 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US12246054 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US11338011 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US10695397 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US10238709 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US11510963 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US11857595 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US11052126 | Method of treating diseases |
Feb, 2036
(10 years from now) | Active |
| US11969471 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 years from now) | Active |
| US11986529 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 years from now) | Active |
| US8535695 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 years from now) | Active |
| US9566246 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 years from now) | Active |
| US8329198 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 years from now) | Active |
| US9265812 | Pharmaceutical compositions and related methods of delivery |
Sep, 2029
(3 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 Mycapssa's patents.
Latest Legal Activities on Mycapssa's Patents
Given below is the list of recent legal activities going on the following patents of Mycapssa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review
Critical | 07 Jun, 2024 | US11969471 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jun, 2024 | US8329198 |
| Mail O.P. Petition Decision | 06 May, 2024 | US11969471 |
| Email Notification
Critical | 06 May, 2024 | US11969471 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 02 May, 2024 | US11969471 |
| Record Petition Decision of Granted to Make Entity Status large | 01 May, 2024 | US11969471 |
| Mail Patent eGrant Notification | 30 Apr, 2024 | US11969471 |
| O.P. Petition Decision | 30 Apr, 2024 | US11969471 |
| Patent eGrant Notification | 30 Apr, 2024 | US11969471 |
| Recordation of Patent eGrant | 30 Apr, 2024 | US11969471 |
FDA has granted several exclusivities to Mycapssa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Mycapssa, 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
Mycapssa.
Exclusivity Information
Mycapssa holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Mycapssa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 26, 2023 |
| Orphan Drug Exclusivity(ODE-474) | Jun 26, 2027 |
US patents provide insights into the exclusivity only within the United States, but
Mycapssa 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 Mycapssa's family patents as well as insights into
ongoing legal events
on those patents.
Mycapssa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mycapssa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 28, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mycapssa Generic API suppliers:
Octreotide Acetate is the generic name for the brand Mycapssa. 11 different companies have already filed for the generic of Mycapssa, with Sun Pharm Inds having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mycapssa's generic
Alternative Brands for Mycapssa
Mycapssa which is used for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide., has several other brand drugs using the same active ingredient (Octreotide 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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Novartis |
| ||
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Octreotide Acetate, Mycapssa's active ingredient. Check the complete list of approved generic manufacturers for Mycapssa
About Mycapssa
Mycapssa is a drug owned by Chiesi Farmaceutici Spa. It is used for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa uses Octreotide Acetate as an active ingredient. Mycapssa was launched by Chiesi in 2020.
Approval Date:
Mycapssa was approved by FDA for market use on 26 June, 2020.
Active Ingredient:
Mycapssa uses Octreotide Acetate as the active ingredient. Check out other Drugs and Companies using Octreotide Acetate ingredient
Treatment:
Mycapssa is used for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Dosage:
Mycapssa is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | CAPSULE, DELAYED RELEASE | Prescription | ORAL |