Relistor is a drug owned by Salix Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2016 to 2019. Out of these, 9 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 10, 2031. Details of Relistor'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). | |||
| US10307417 | Oral formulations and lipophilic salts of methylnaltrexone |
Mar, 2031
(6 years from now) | Active |
| US8524276 | Oral formulations and lipophilic salts of methylnaltrexone |
Mar, 2031
(6 years from now) | Active |
| US10376505 | Oral formulations and lipophilic salts of methylnaltrexone |
Mar, 2031
(6 years from now) | Active |
| US9314461 | Oral formulations and lipophilic salts of methylnaltrexone |
Mar, 2031
(6 years from now) | Active |
| US8956651 | Oral formulations and lipophilic salts of methylnal trexone |
Mar, 2031
(6 years from now) | Active |
| US9180125 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US9492445 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US9724343 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US8420663 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US6559158 | Use of methylnaltrexone and related compounds to treat chronic opioid use side affects |
Nov, 2017
(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 Relistor's patents.
Latest Legal Activities on Relistor's Patents
Given below is the list of recent legal activities going on the following patents of Relistor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jan, 2024 | US8247425 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2023 | US9314461 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9180125 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10376505 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10376584 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Nov, 2022 | US10307417 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jul, 2022 | US8956651 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2022 | US8822490 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Mar, 2021 | US8552025 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Feb, 2021 | US8524276 |
FDA has granted several exclusivities to Relistor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Relistor, 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 Relistor.
Exclusivity Information
Relistor holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Relistor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 24, 2013 |
| New Product(NP) | Jul 19, 2019 |
US patents provide insights into the exclusivity only within the United States, but Relistor 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 Relistor's family patents as well as insights into ongoing legal events on those patents.
Relistor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Relistor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 10, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Relistor Generic API suppliers:
Methylnaltrexone Bromide is the generic name for the brand Relistor. 1 company has already filed for the generic of Relistor. Check out the entire list of companies who have already received approval for Relistor's generic
How can I launch a generic of Relistor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Relistor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Relistor'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 Relistor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12 mg/0.6 mL | 22 Jul, 2015 | 1 | 31 Dec, 2030 | ||
| 8 mg/0.4 mL | 08 Sep, 2015 | 1 | 31 Dec, 2030 | ||
| 150 mg | 06 Sep, 2016 | 1 | 10 Mar, 2031 |
Alternative Brands for Relistor
Relistor which is used for managing opioid-induced constipation., 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.
About Relistor
Relistor is a drug owned by Salix Pharmaceuticals Inc. It is used for managing opioid-induced constipation. Relistor uses Methylnaltrexone Bromide as an active ingredient. Relistor was launched by Salix in 2016.
Approval Date:
Relistor was approved by FDA for market use on 19 July, 2016.
Active Ingredient:
Relistor uses Methylnaltrexone Bromide as the active ingredient. Check out other Drugs and Companies using Methylnaltrexone Bromide ingredient
Treatment:
Relistor is used for managing opioid-induced constipation.
Dosage:
Relistor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
Relistor is a drug owned by Salix Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2013 to 2019. Out of these, 5 drug patents are active and 4 have expired. Relistor's patents have been open to challenges since 24 April, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 31, 2030. Details of Relistor'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). | |||
| US8247425 | Peripheral opioid receptor antagonists and uses thereof |
Dec, 2030
(6 years from now) | Active |
| US9180125 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US9492445 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US8822490 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US8420663 | Peripheral opioid receptor antagonists and uses thereof |
Sep, 2029
(4 years from now) | Active |
| US8552025 | Stable methylnaltrexone preparation |
Apr, 2024
(7 months ago) |
Expired
|
| US10376584 | Stable pharmaceutical formulations of methylnaltrexone |
Apr, 2024
(7 months ago) |
Expired
|
| US9669096 | Stable pharmaceutical formulations of methylnaltrexone |
Apr, 2024
(7 months ago) |
Expired
|
| US6559158 | Use of methylnaltrexone and related compounds to treat chronic opioid use side affects |
Nov, 2017
(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 Relistor's patents.
Latest Legal Activities on Relistor's Patents
Given below is the list of recent legal activities going on the following patents of Relistor.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jan, 2024 | US8247425 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2023 | US9314461 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9180125 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10376505 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jan, 2023 | US10376584 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Nov, 2022 | US10307417 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jul, 2022 | US8956651 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2022 | US8822490 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Mar, 2021 | US8552025 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Feb, 2021 | US8524276 |
FDA has granted several exclusivities to Relistor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Relistor, 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 Relistor.
Exclusivity Information
Relistor holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Relistor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 24, 2013 |
| New Product(NP) | Jul 19, 2019 |
Several oppositions have been filed on Relistor'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 Relistor's generic, the next section provides detailed information on ongoing and past EP oppositions related to Relistor patents.
Relistor's Oppositions Filed in EPO
Relistor has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 24, 2015, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP10184684A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10184575A | Sep, 2015 | Actavis Group PTC ehf | Revoked |
| EP10184575A | Sep, 2015 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP04759349A | Sep, 2015 | Actavis Group PTC ehf | Patent maintained as amended |
| EP04759349A | Sep, 2015 | Fresenius Kabi Deutschland GmbH | Patent maintained as amended |
| EP10184684A | Sep, 2015 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP10184684A | Sep, 2015 | Actavis Group PTC ehf | Revoked |
US patents provide insights into the exclusivity only within the United States, but Relistor 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 Relistor's family patents as well as insights into ongoing legal events on those patents.
Relistor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Relistor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 31, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Relistor Generic API suppliers:
Methylnaltrexone Bromide is the generic name for the brand Relistor. 1 company has already filed for the generic of Relistor. Check out the entire list of companies who have already received approval for Relistor's generic
How can I launch a generic of Relistor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Relistor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Relistor'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 Relistor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12 mg/0.6 mL | 22 Jul, 2015 | 1 | 31 Dec, 2030 | ||
| 8 mg/0.4 mL | 08 Sep, 2015 | 1 | 31 Dec, 2030 | ||
| 150 mg | 06 Sep, 2016 | 1 | 10 Mar, 2031 |
Alternative Brands for Relistor
Relistor which is used for managing opioid-induced constipation., 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.
About Relistor
Relistor is a drug owned by Salix Pharmaceuticals Inc. It is used for managing opioid-induced constipation. Relistor uses Methylnaltrexone Bromide as an active ingredient. Relistor was launched by Salix Pharms in 2010.
Approval Date:
Relistor was approved by FDA for market use on 27 September, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Relistor is 27 September, 2010, its NCE-1 date is estimated to be 24 April, 2012.
Active Ingredient:
Relistor uses Methylnaltrexone Bromide as the active ingredient. Check out other Drugs and Companies using Methylnaltrexone Bromide ingredient
Treatment:
Relistor is used for managing opioid-induced constipation.
Dosage:
Relistor is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12MG/0.6ML (12MG/0.6ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 8MG/0.4ML (8MG/0.4ML) | SOLUTION | Prescription | SUBCUTANEOUS |