Lyrica is a drug owned by Upjohn Us 2 Llc. It is protected by 7 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 23, 2022. Details of Lyrica'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). | |||
|
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
|
|
US6001876 (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
|
| US6001876 | Isobutylgaba and its derivatives for the treatment of pain |
Dec, 2018
(5 years ago) |
Expired
|
| US6197819 | Gamma amino butyric acid analogs and optical isomers |
Dec, 2018
(5 years ago) |
Expired
|
| US5563175 | GABA and L-glutamic acid analogs for antiseizure treatment |
Oct, 2013
(11 years ago) |
Expired
|
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 and ongoing litigations to help you estimate the early arrival of Lyrica generic.
Lyrica's Litigations
Lyrica 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'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. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lyrica, 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.
Exclusivity Information
Lyrica holds 4 exclusivities. All of its exclusivities have expired in 2022. Details of Lyrica's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-651) | Jun 20, 2015 |
| M(M-193) | Dec 22, 2019 |
| New Patient Population(NPP) | May 23, 2022 |
| Pediatric Exclusivity(PED) | Nov 23, 2022 |
US patents provide insights into the exclusivity only within the United States, but Lyrica 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's family patents as well as insights into ongoing legal events on those patents.
Lyrica's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lyrica's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 23, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lyrica Generic API suppliers:
Pregabalin is the generic name for the brand Lyrica. 33 different companies have already filed for the generic of Lyrica, with Adaptis having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lyrica's generic
How can I launch a generic of Lyrica before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lyrica's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lyrica'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg | 30 Dec, 2008 | 8 | 30 Dec, 2018 | Extinguished | |
| 20 mg/mL | 19 May, 2010 | 1 | 30 Dec, 2018 | Extinguished |
Alternative Brands for Lyrica
Lyrica which is used for managing fibromyalgia, treating various types of pain, and seizure disorders., has several other brand drugs in the same treatment category and 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 | Treatment Area | ||
|---|---|---|---|---|
| Abbvie |
| |||
| Btcp Pharma |
| |||
| Fresenius Kabi Usa |
| |||
| Genus |
| |||
| Recro Gainesville |
| |||
| Tersera |
| |||
| Zyla |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Pregabalin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Upjohn |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Pregabalin, Lyrica's active ingredient. Check the complete list of approved generic manufacturers for Lyrica
About Lyrica
Lyrica is a drug owned by Upjohn Us 2 Llc. It is used for managing fibromyalgia, treating various types of pain, and seizure disorders. Lyrica uses Pregabalin as an active ingredient. Lyrica was launched by Upjohn in 2004.
Approval Date:
Lyrica was approved by FDA for market use on 30 December, 2004.
Active Ingredient:
Lyrica uses Pregabalin as the active ingredient. Check out other Drugs and Companies using Pregabalin ingredient
Treatment:
Lyrica is used for managing fibromyalgia, treating various types of pain, and seizure disorders.
Dosage:
Lyrica is available in the following dosage forms - solution form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 75MG | CAPSULE | Prescription | ORAL |
| 50MG | CAPSULE | Prescription | ORAL |
| 25MG | CAPSULE | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |
| 20MG/ML | SOLUTION | Prescription | ORAL |
| 225MG | CAPSULE | Prescription | ORAL |
| 200MG | CAPSULE | Prescription | ORAL |
| 300MG | CAPSULE | Prescription | ORAL |
| 150MG | CAPSULE | Prescription | ORAL |