Lazanda is a drug owned by Btcp Pharma Llc. It is protected by 6 US drug patents filed from 2013 to 2018. Out of these, 1 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 26, 2032. Details of Lazanda'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). | |||
| US9731869 | Container |
Jan, 2032
(6 years from now) | Active |
| US8216604 | Method of managing or treating pain |
Oct, 2024
(1 year, 27 days ago) |
Expired
|
| US8889176 | Method of managing or treating pain |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
| US9078814 | Intranasal spray device containing pharmaceutical composition |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
| US9814705 | Intranasal spray device containing pharmaceutical composition |
Jan, 2024
(1 year, 9 months ago) |
Expired
|
| US6432440 | Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces |
Apr, 2018
(7 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 Lazanda's patents.
Latest Legal Activities on Lazanda's Patents
Given below is the list of recent legal activities going on the following patents of Lazanda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed
Critical | 26 Feb, 2024 | US8216604 |
| Expire Patent
Critical | 21 Aug, 2023 | US9078814 |
| Maintenance Fee Reminder Mailed
Critical | 06 Mar, 2023 | US9078814 |
| Expire Patent
Critical | 26 Dec, 2022 | US8889176 |
| Maintenance Fee Reminder Mailed
Critical | 11 Jul, 2022 | US8889176 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 May, 2021 | US9814705 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2021 | US9731869 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2020 | US8216604 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 Apr, 2019 | US8889176 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 22 Apr, 2019 | US8216604 |
FDA has granted several exclusivities to Lazanda. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Lazanda, 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
Lazanda.
Exclusivity Information
Lazanda holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Lazanda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 30, 2014 |
Several oppositions have been filed on Lazanda'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 Lazanda's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Lazanda patents.
Lazanda's Oppositions Filed in EPO
Lazanda has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 18, 2014, by Generics [Uk] Limited. This opposition was filed on patent number EP04701381A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04701381A | Jun, 2014 | Generics [UK] Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Lazanda 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 Lazanda's family patents as well as insights into
ongoing legal events
on those patents.
Lazanda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lazanda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 26, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lazanda Generic API suppliers:
Fentanyl Citrate is the generic name for the brand Lazanda. 9 different companies have already filed for the generic of Lazanda, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lazanda's generic
Alternative Brands for Lazanda
Lazanda which is used for managing breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy., has several other brand drugs in the same treatment category and using the same active ingredient (Fentanyl Citrate). 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 | ||
|---|---|---|---|---|
| Adalvo |
| |||
| Cephalon |
| |||
| Sentynl Theraps Inc |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fentanyl Citrate, Lazanda's active ingredient. Check the complete list of approved generic manufacturers for Lazanda
About Lazanda
Lazanda is a drug owned by Btcp Pharma Llc. It is used for managing breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy. Lazanda uses Fentanyl Citrate as an active ingredient. Lazanda was launched by Btcp Pharma in 2011.
Approval Date:
Lazanda was approved by FDA for market use on 30 June, 2011.
Active Ingredient:
Lazanda uses Fentanyl Citrate as the active ingredient. Check out other Drugs and Companies using Fentanyl Citrate ingredient
Treatment:
Lazanda is used for managing breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy.
Dosage:
Lazanda is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |
| EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |
| EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | Discontinued | NASAL |