Lyrica Cr is a drug owned by Upjohn Us 2 Llc. It is protected by 10 US drug patents filed in 2018. Out of these, 6 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 02, 2027. Details of Lyrica Cr'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. | |||
| US6197819 | Gamma amino butyric acid analogs and optical isomers |
Dec, 2018
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9144559 (Pediatric) | Solid pharmaceutical compositions containing pregabalin |
May, 2027
(2 years from now) | Active |
|
US10022447 (Pediatric) | Solid pharmaceutical compositions containing pregabalin |
May, 2027
(2 years from now) | Active |
|
US8945620 (Pediatric) | Solid pharmaceutical compositions containing pregabalin |
May, 2027
(2 years from now) | Active |
| US8945620 | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(1 year, 11 months from now) | Active |
| US9144559 | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(1 year, 11 months from now) | Active |
| US10022447 | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(1 year, 11 months from now) | Active |
|
US6197819 (Pediatric) | Gamma amino butyric acid analogs and optical isomers |
Jun, 2019
(5 years ago) |
Expired
|
|
USRE41920 (Pediatric) | Isobutylgaba and its derivatives for the treatment of pain |
Jun, 2019
(5 years ago) |
Expired
|
| USRE41920 | Isobutylgaba and its derivatives for the treatment of pain |
Dec, 2018
(5 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 Lyrica Cr's patents.
Latest Legal Activities on Lyrica Cr's Patents
Given below is the list of recent legal activities going on the following patents of Lyrica Cr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2023 | US9144559 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jul, 2022 | US8945620 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jan, 2022 | US10022447 |
| Email Notification Critical | 29 Jul, 2021 | US8945620 |
| Email Notification Critical | 29 Jul, 2021 | US9144559 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Jul, 2021 | US8945620 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Jul, 2021 | US9144559 |
| Correspondence Address Change Critical | 27 Jul, 2021 | US9144559 |
| Correspondence Address Change Critical | 27 Jul, 2021 | US8945620 |
| Email Notification Critical | 14 Jul, 2021 | US10022447 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lyrica Cr and ongoing litigations to help you estimate the early arrival of Lyrica Cr generic.
Lyrica Cr's Litigations
Lyrica Cr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 29, 1996, against patent number US6197819. The petitioner , challenged the validity of this patent, with SILVERMAN et al as the respondent. Click below to track the latest information on how companies are challenging Lyrica Cr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6197819 | October, 1996 |
Decision
(10 Jul, 1997) | SILVERMAN et al | |
FDA has granted some exclusivities to Lyrica Cr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lyrica Cr, 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 Lyrica Cr.
Exclusivity Information
Lyrica Cr holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Lyrica Cr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 11, 2020 |
| Pediatric Exclusivity(PED) | Apr 11, 2021 |
Several oppositions have been filed on Lyrica Cr'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 Lyrica Cr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lyrica Cr patents.
Lyrica Cr's Oppositions Filed in EPO
Lyrica Cr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 21, 2014, by Strawman Limited. This opposition was filed on patent number EP06809154A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06809154A | Oct, 2014 | STRAWMAN LIMITED | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Lyrica Cr 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 Lyrica Cr's family patents as well as insights into ongoing legal events on those patents.
Lyrica Cr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lyrica Cr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 02, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lyrica Cr Generic API suppliers:
Pregabalin is the generic name for the brand Lyrica Cr. 33 different companies have already filed for the generic of Lyrica Cr, with Adaptis having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lyrica Cr's generic
How can I launch a generic of Lyrica Cr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lyrica Cr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lyrica Cr'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 Lyrica Cr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 330 mg | 29 Jan, 2018 | 1 | 12 Apr, 2021 | 02 Nov, 2026 | Extinguished |
| 82.5 mg and 165 mg | 02 Feb, 2018 | 1 | 12 Apr, 2021 | 02 Nov, 2026 | Extinguished |
Alternative Brands for Lyrica Cr
Lyrica Cr which is used for treating neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia., has several other brand drugs using the same active ingredient (Pregabalin). 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 | |
|---|---|---|
| Upjohn |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pregabalin, Lyrica Cr's active ingredient. Check the complete list of approved generic manufacturers for Lyrica Cr
About Lyrica Cr
Lyrica Cr is a drug owned by Upjohn Us 2 Llc. It is used for treating neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Lyrica Cr uses Pregabalin as an active ingredient. Lyrica Cr was launched by Upjohn in 2017.
Approval Date:
Lyrica Cr was approved by FDA for market use on 11 October, 2017.
Active Ingredient:
Lyrica Cr uses Pregabalin as the active ingredient. Check out other Drugs and Companies using Pregabalin ingredient
Treatment:
Lyrica Cr is used for treating neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.
Dosage:
Lyrica Cr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 82.5MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 165MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 330MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |