Morphine Sulfate is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed from 2015 to 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 12, 2034. Details of Morphine Sulfate'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). | |||
| US9192608 | Morphine formulations |
Mar, 2034
(8 years from now) | Active |
| US9248229 | Packaging system for oxygen-sensitive drugs |
Mar, 2034
(8 years from now) | Active |
| US9072781 | Morphine formulations |
Mar, 2034
(8 years from now) | Active |
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 Morphine Sulfate's patents.
Latest Legal Activities on Morphine Sulfate's Patents
Given below is the list of recent legal activities going on the following patents of Morphine Sulfate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2023 | US9248229 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 May, 2023 | US9192608 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2023 | US9072781 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Aug, 2019 | US9248229 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 May, 2019 | US9192608 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jan, 2019 | US9072781 |
| Email Notification Critical | 12 Sep, 2016 | US9192608 |
| Filing Receipt - Corrected | 12 Sep, 2016 | US9072781 |
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Sep, 2016 | US9192608 |
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Sep, 2016 | US9072781 |
FDA has granted several exclusivities to Morphine Sulfate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Morphine Sulfate, 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 Morphine Sulfate.
Exclusivity Information
Morphine Sulfate holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Morphine Sulfate's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 02, 2024 |
US patents provide insights into the exclusivity only within the United States, but Morphine Sulfate 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 Morphine Sulfate's family patents as well as insights into ongoing legal events on those patents.
Morphine Sulfate's Family Patents
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Generic Launch
Generic Release Date:
Morphine Sulfate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 12, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Morphine Sulfate Generic API suppliers:
Morphine Sulfate is the generic name for the brand Morphine Sulfate. 32 different companies have already filed for the generic of Morphine Sulfate, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Morphine Sulfate's generic
Alternative Brands for Morphine Sulfate
Morphine Sulfate which is used for managing chronic pain and treating pain in patients requiring opioid analgesia., has several other brand drugs in the same treatment category and using the same active ingredient (Morphine Sulfate). 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 | ||
|---|---|---|---|---|
| Btcp Pharma |
| |||
| Genus |
| |||
| Recro Gainesville |
| |||
| Tersera |
| |||
| Upjohn |
| |||
| 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. Morphine Sulfate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Alpharma Pharms |
| |
| King Pharms Llc |
| |
| Ohemo Life |
| |
| Pacira Pharms Inc |
| |
| Zyla |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Morphine Sulfate, Morphine Sulfate's active ingredient. Check the complete list of approved generic manufacturers for Morphine Sulfate
About Morphine Sulfate
Morphine Sulfate is a drug owned by Fresenius Kabi Usa Llc. It is used for managing chronic pain and treating pain in patients requiring opioid analgesia. Morphine Sulfate uses Morphine Sulfate as an active ingredient. Morphine Sulfate was launched by Fresenius Kabi Usa in 2013.
Approval Date:
Morphine Sulfate was approved by FDA for market use on 30 October, 2013.
Active Ingredient:
Morphine Sulfate uses Morphine Sulfate as the active ingredient. Check out other Drugs and Companies using Morphine Sulfate ingredient
Treatment:
Morphine Sulfate is used for managing chronic pain and treating pain in patients requiring opioid analgesia.
Dosage:
Morphine Sulfate is available in solution form for intramuscular, intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/ML (2MG/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS |
| 10MG/ML (10MG/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS |
| 4MG/ML (4MG/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS |
| 5MG/ML (5MG/ML) | SOLUTION | Discontinued | INTRAMUSCULAR, INTRAVENOUS |
| 8MG/ML (8MG/ML) | SOLUTION | Discontinued | INTRAMUSCULAR, INTRAVENOUS |