Azilect is a drug owned by Teva Neuroscience Inc. It is protected by 5 US drug patents filed in 2013. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 27, 2027. Details of Azilect'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. | |||
| US7815942 | Rasagiline formulations of improved content uniformity |
Aug, 2027
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7572834 | Rasagiline formulations and processes for their preparation |
Dec, 2026
(1 year, 1 month from now) | Active |
| US5453446 | Use of the R-enantiomers of N-propargyl 1-aminoindan compounds for treating Parkinson's disease. |
Feb, 2017
(8 years ago) |
Expired
|
| US6126968 | Stable compositions containing N-propargyl-1-aminoindan |
Sep, 2016
(9 years ago) |
Expired
|
| US5532415 | R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof |
Jul, 2013
(12 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 Azilect's patents.
Latest Legal Activities on Azilect's Patents
Given below is the list of recent legal activities going on the following patents of Azilect.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Apr, 2022 | US7815942 |
| Expire Patent
Critical | 13 Sep, 2021 | US7572834 |
| Maintenance Fee Reminder Mailed
Critical | 29 Mar, 2021 | US7572834 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Apr, 2018 | US7815942 |
| Patent Issue Date Used in PTA Calculation
Critical | 19 Oct, 2010 | US7815942 |
| Recordation of Patent Grant Mailed
Critical | 19 Oct, 2010 | US7815942 |
| Issue Notification Mailed
Critical | 29 Sep, 2010 | US7815942 |
| Dispatch to FDC | 17 Sep, 2010 | US7815942 |
| Issue Fee Payment Received
Critical | 13 Sep, 2010 | US7815942 |
| Issue Fee Payment Verified
Critical | 13 Sep, 2010 | US7815942 |
FDA has granted several exclusivities to Azilect. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Azilect, 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
Azilect.
Exclusivity Information
Azilect holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Azilect's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-685) | May 29, 2017 |
Several oppositions have been filed on Azilect'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 Azilect's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Azilect patents.
Azilect's Oppositions Filed in EPO
Azilect has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 13, 2017, by Generics (U.K.) Limited. This opposition was filed on patent number EP06720975A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06720975A | Feb, 2017 | Generics (U.K.) Limited | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Azilect 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 Azilect's family patents as well as insights into
ongoing legal events
on those patents.
Azilect's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Azilect's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 27, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Azilect Generic API suppliers:
Rasagiline Mesylate is the generic name for the brand Azilect. 12 different companies have already filed for the generic of Azilect, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Azilect's generic
Alternative Brands for Azilect
Azilect which is used for managing the symptoms of Parkinson's disease., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch |
| |||||||||||||||
| Boehringer Ingelheim |
| |||||||||||||||
| Impax |
| |||||||||||||||
| Orion Pharma |
| |||||||||||||||
| Supernus Pharms |
| |||||||||||||||
About Azilect
Azilect is a drug owned by Teva Neuroscience Inc. It is used for managing the symptoms of Parkinson's disease. Azilect uses Rasagiline Mesylate as an active ingredient. Azilect was launched by Teva in 2006.
Approval Date:
Azilect was approved by FDA for market use on 16 May, 2006.
Active Ingredient:
Azilect uses Rasagiline Mesylate as the active ingredient. Check out other Drugs and Companies using Rasagiline Mesylate ingredient
Treatment:
Azilect is used for managing the symptoms of Parkinson's disease.
Dosage:
Azilect is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE | TABLET | Prescription | ORAL |
| EQ 0.5MG BASE | TABLET | Prescription | ORAL |