Hemangeol is a drug owned by Pierre Fabre Medicament. It is protected by 2 US drug patents filed from 2014 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 16, 2028. Details of Hemangeol'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). | |||
| US8338489 | Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas |
Oct, 2028
(3 years from now) | Active |
| US8987262 | Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas |
Oct, 2028
(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 Hemangeol's patents.
Latest Legal Activities on Hemangeol's Patents
Given below is the list of recent legal activities going on the following patents of Hemangeol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 May, 2024 | US8338489 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 May, 2020 | US8338489 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Dec, 2012 | US8338489 |
| Recordation of Patent Grant Mailed Critical | 25 Dec, 2012 | US8338489 |
| Issue Notification Mailed Critical | 05 Dec, 2012 | US8338489 |
| Dispatch to FDC | 29 Nov, 2012 | US8338489 |
| Application Is Considered Ready for Issue Critical | 19 Nov, 2012 | US8338489 |
| Issue Fee Payment Verified Critical | 16 Nov, 2012 | US8338489 |
| Response to Reasons for Allowance | 16 Nov, 2012 | US8338489 |
| Issue Fee Payment Received Critical | 16 Nov, 2012 | US8338489 |
FDA has granted several exclusivities to Hemangeol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Hemangeol, 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 Hemangeol.
Exclusivity Information
Hemangeol holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Hemangeol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 14, 2017 |
| Orphan Drug Exclusivity(ODE) | Mar 14, 2021 |
| Orphan Drug Exclusivity(ODE-62) | Mar 14, 2021 |
Several oppositions have been filed on Hemangeol'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 Hemangeol's generic, the next section provides detailed information on ongoing and past EP oppositions related to Hemangeol patents.
Hemangeol's Oppositions Filed in EPO
Hemangeol has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 09, 2012, by Infectopharm Arzneimittel Und Consilium Gmbh. This opposition was filed on patent number EP08838691A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08838691A | Mar, 2012 | Infectopharm Arzneimittel und Consilium GmbH | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Hemangeol 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 Hemangeol's family patents as well as insights into ongoing legal events on those patents.
Hemangeol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hemangeol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 16, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hemangeol Generic API suppliers:
Propranolol Hydrochloride is the generic name for the brand Hemangeol. 43 different companies have already filed for the generic of Hemangeol, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hemangeol's generic
How can I launch a generic of Hemangeol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hemangeol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hemangeol'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 Hemangeol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4.28 mg/mL | 21 Jul, 2022 | 1 | 16 Oct, 2028 |
Alternative Brands for Hemangeol
Hemangeol which is used for treating hemangioma, including infantile hemangioma., has several other brand drugs using the same active ingredient (Propranolol Hydrochloride). 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 | |
|---|---|---|
| Ani Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Propranolol Hydrochloride, Hemangeol's active ingredient. Check the complete list of approved generic manufacturers for Hemangeol
About Hemangeol
Hemangeol is a drug owned by Pierre Fabre Medicament. It is used for treating hemangioma, including infantile hemangioma. Hemangeol uses Propranolol Hydrochloride as an active ingredient. Hemangeol was launched by Pierre Fabre in 2014.
Approval Date:
Hemangeol was approved by FDA for market use on 14 March, 2014.
Active Ingredient:
Hemangeol uses Propranolol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Propranolol Hydrochloride ingredient
Treatment:
Hemangeol is used for treating hemangioma, including infantile hemangioma.
Dosage:
Hemangeol is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4.28MG/ML | SOLUTION | Prescription | ORAL |