Morphine Sulfate Patent Expiration

Morphine Sulfate was first introduced by Hikma Pharmaceuticals Usa Inc in its drug Duramorph Pf on Sep 18, 1984. Other drugs containing Morphine Sulfate are Oramorph Sr, Morphine Sulfate, Arymo Er, Avinza, Ms Contin, Infumorph, Kadian, Depodur, Morphine Sulfate (Autoinjector), Morphabond Er. 42 different companies have introduced drugs containing Morphine Sulfate.


Morphine Sulfate Patents

Given below is the list of patents protecting Morphine Sulfate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Morphine Sulfate US9072781 Morphine formulations Mar 12, 2034 Fresenius Kabi Usa
Morphine Sulfate US9192608 Morphine formulations Mar 12, 2034 Fresenius Kabi Usa
Morphine Sulfate US9248229 Packaging system for oxygen-sensitive drugs Mar 12, 2034 Fresenius Kabi Usa
Arymo Er US9044402 Abuse-deterrent pharmaceutical compositions for controlled release Jul 01, 2033 Zyla
Arymo Er US9549899 Abuse deterrent pharmaceutical compositions for controlled release Jul 01, 2033 Zyla
Morphabond Er US10314788 Pharmaceutical compositions configured to deter dosage form splitting Aug 12, 2028 Ohemo Life
Morphabond Er US7955619 Abuse resistant drugs, method of use and method of making Aug 12, 2028 Ohemo Life
Avinza US6066339 Oral morphine multiparticulate formulation Nov 25, 2017

(Expired)

King Pharms Llc
Depodur US5891467 Method for utilizing neutral lipids to modify in vivo release from multivesicular liposomes Jan 31, 2017

(Expired)

Pacira Pharms Inc
Depodur US5962016 Multivesicular liposomes utilizing neutral lipids to modify in vivo release Jan 31, 2017

(Expired)

Pacira Pharms Inc
Depodur US6171613 Method for producing liposomes with increased percent of compound encapsulated Oct 01, 2016

(Expired)

Pacira Pharms Inc
Depodur US5997899 Method for producing liposomes with increased percent of compound encapsulated Sep 01, 2016

(Expired)

Pacira Pharms Inc
Depodur US6193998 Method for producing liposomes with increased percent of compound encapsulated Sep 01, 2016

(Expired)

Pacira Pharms Inc
Depodur US6241999 Method for producing liposomes with increased percent of compound encapsulated Sep 01, 2016

(Expired)

Pacira Pharms Inc
Depodur US5807572 Multivesicular liposomes having a biologically active substance encapsulated therein in the presence of a hydrochloride Sep 15, 2015

(Expired)

Pacira Pharms Inc
Depodur US5931809 Epidural administration of therapeutic compounds with sustained rate of release Jul 14, 2015

(Expired)

Pacira Pharms Inc
Depodur US5723147 Multivesicular liposomes having a biologically active substance encapsulated therein in the presence of a hydrochloride Mar 03, 2015

(Expired)

Pacira Pharms Inc



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.

Given below is the list recent legal activities going on the following patents of Morphine Sulfate.

Activity Date Patent Number
Patent litigations
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 12 Sep, 2016 US9192608
Filing Receipt - Corrected 12 Sep, 2016 US9072781
Change in Power of Attorney (May Include Associate POA) 12 Sep, 2016 US9192608
Change in Power of Attorney (May Include Associate POA) 12 Sep, 2016 US9072781


Morphine Sulfate's Family Patents

Family Patents

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Morphine Sulfate Generics

Several generic applications have been filed for Morphine Sulfate. The first generic version for Morphine Sulfate was by Fresenius Kabi Usa Llc and was approved on Oct 7, 1986. And the latest generic version is by Pharmaceutical Associates Inc and was approved on Sep 12, 2023.

Given below is the list of companies who have filed for Morphine Sulfate generic.


1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 9 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet, extended release Prescription ORAL AB Apr 6, 2015
120MG

(reference standard)

capsule, extended release Prescription ORAL N/A Jan 16, 2013
90MG capsule, extended release Prescription ORAL N/A Jan 16, 2013
75MG capsule, extended release Prescription ORAL N/A Jan 16, 2013
60MG tablet, extended release Prescription ORAL AB Apr 6, 2015
45MG capsule, extended release Prescription ORAL N/A Jan 16, 2013
15MG tablet, extended release Prescription ORAL AB Apr 6, 2015
200MG tablet, extended release Prescription ORAL AB Apr 6, 2015
100MG tablet, extended release Prescription ORAL AB Apr 6, 2015


2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MG tablet Prescription ORAL AB Dec 3, 2020
30MG tablet Prescription ORAL AB Dec 3, 2020


3. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 3 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML solution Discontinued ORAL N/A Apr 17, 2018
20MG/5ML solution Discontinued ORAL N/A Apr 17, 2018
10MG/5ML solution Discontinued ORAL N/A Apr 17, 2018


4. CHARTWELL MOLECULAR

Chartwell Molecular Holdings Llc has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/5ML solution Discontinued ORAL N/A Oct 30, 2015
10MG/5ML solution Discontinued ORAL N/A Nov 25, 2015


5. DAVA PHARMS INC

Dava Pharmaceuticals Inc has filed for 1 generic for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Dava Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MG tablet, extended release Prescription ORAL AB Jan 28, 2000


6. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 4 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Discontinued ORAL N/A Jan 12, 2022
15MG tablet Discontinued ORAL N/A Jan 12, 2022
60MG tablet, extended release Discontinued ORAL N/A Oct 28, 2016
100MG tablet, extended release Discontinued ORAL N/A Oct 28, 2016


7. EPIC PHARMA LLC

Epic Pharma Llc has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, extended release Discontinued ORAL N/A Jun 23, 2016
15MG tablet, extended release Discontinued ORAL N/A Jun 23, 2016
30MG tablet, extended release Discontinued ORAL N/A Jun 23, 2016
60MG tablet, extended release Discontinued ORAL N/A Jun 23, 2016
200MG tablet, extended release Discontinued ORAL N/A Jun 23, 2016


8. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Morphine Sulfate. All of these versions come by the name ASTRAMORPH PF. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/ML injectable Discontinued INJECTION N/A Oct 7, 1986
1MG/ML injectable Discontinued INJECTION N/A Oct 7, 1986


9. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG/ML injectable Prescription INJECTION AP Jan 12, 2023
8MG/ML injectable Prescription INJECTION AP Jan 12, 2023
10MG/ML injectable Prescription INJECTION AP Jan 12, 2023
100MG/5ML solution Discontinued ORAL N/A Jul 6, 2017
2MG/ML injectable Prescription INJECTION AP Jan 12, 2023
15MG/ML injectable Prescription INJECTION N/A Jan 12, 2023


10. HOSPIRA

Hospira Inc has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML injectable Prescription INJECTION AP Sep 30, 1992
0.5MG/ML injectable Prescription INJECTION AP Sep 30, 1992


11. IMPAX LABS INC

Impax Laboratories Inc has filed for 7 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
60MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
50MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
30MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
20MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
80MG capsule, extended release Discontinued ORAL N/A Apr 12, 2016
40MG capsule, extended release Discontinued ORAL N/A Jul 25, 2018


12. INGENUS PHARMS NJ

Ingenus Pharmaceuticals Nj Llc has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Ingenus Pharms Nj.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet Discontinued ORAL N/A Feb 7, 2022
15MG tablet Discontinued ORAL N/A Feb 7, 2022


13. INTL MEDICATION SYS

International Medication Systems Ltd has filed for 1 generic for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Intl Medication Sys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML injectable Prescription INJECTION N/A Apr 29, 2021


14. NESHER PHARMS

Nesher Pharmaceuticals Usa Llc has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Nesher Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG tablet, extended release Discontinued ORAL N/A May 19, 2004
15MG tablet, extended release Discontinued ORAL N/A May 19, 2004
30MG tablet, extended release Discontinued ORAL N/A Dec 23, 2005
100MG tablet, extended release Discontinued ORAL N/A Sep 27, 2007
200MG tablet, extended release Discontinued ORAL N/A Sep 27, 2007


15. NORTEC DEV ASSOC

Nortec Development Assoc Inc has filed for 6 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Nortec Dev Assoc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021
30MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021
20MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021
60MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021
80MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021
100MG capsule, extended release Discontinued ORAL N/A Aug 4, 2021


16. NOSTRUM LABS INC

Nostrum Laboratories Inc has filed for 3 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/5ML solution Discontinued ORAL N/A Feb 5, 2014
20MG/5ML solution Discontinued ORAL N/A Feb 5, 2014
100MG/5ML solution Prescription ORAL AA Oct 6, 2016


17. NOVEL LABS INC

Novel Laboratories Inc has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, extended release Prescription ORAL AB Dec 16, 2015
30MG tablet, extended release Prescription ORAL AB Dec 16, 2015
200MG tablet, extended release Prescription ORAL AB Dec 16, 2015
15MG tablet, extended release Prescription ORAL AB Dec 16, 2015
60MG tablet, extended release Prescription ORAL AB Dec 16, 2015


18. PADAGIS US

Padagis Us Llc has filed for 1 generic for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML solution Prescription ORAL AA Aug 6, 2012


19. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML solution Discontinued ORAL N/A Nov 14, 2016
10MG/5ML solution Discontinued ORAL N/A Sep 12, 2023


20. PIRAMAL CRITICAL

Piramal Critical Care Inc has filed for 2 different strengths of generic version for Morphine Sulfate. All of these versions come by the name MITIGO. Given below are the details of the strengths of this generic introduced by Piramal Critical.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML injectable Prescription INJECTION AP Jul 16, 2018
25MG/ML injectable Prescription INJECTION AP Jul 16, 2018


21. RHODES PHARMS

Rhodes Pharmaceuticals Lp has filed for 8 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Rhodes Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet, extended release Prescription ORAL AB Jul 2, 1998
100MG tablet, extended release Prescription ORAL AB Jul 2, 1998
60MG tablet, extended release Prescription ORAL AB Jul 7, 1998
30MG tablet, extended release Prescription ORAL AB Jul 7, 1998
15MG tablet, extended release Prescription ORAL AB Jul 7, 1998
20MG/5ML solution Prescription ORAL AA Jul 12, 2016
100MG/5ML solution Prescription ORAL AA Jun 22, 2017
10MG/5ML solution Prescription ORAL AA Jun 22, 2017


22. RISING

Rising Pharma Holdings Inc has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG tablet, extended release Discontinued ORAL N/A Oct 18, 2011
100MG tablet, extended release Discontinued ORAL N/A Oct 18, 2011
200MG tablet, extended release Discontinued ORAL N/A Oct 18, 2011
15MG tablet, extended release Discontinued ORAL N/A Oct 18, 2011
60MG tablet, extended release Discontinued ORAL N/A Oct 18, 2011


23. SPECGX LLC

Specgx Llc has filed for 6 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, extended release Prescription ORAL AB Jul 3, 2003
200MG tablet, extended release Prescription ORAL AB Jul 3, 2003
15MG tablet Prescription ORAL AB Aug 21, 2023
30MG tablet Prescription ORAL AB Aug 21, 2023
60MG tablet, extended release Prescription ORAL AB Jul 31, 2003
100MG/5ML solution Prescription ORAL AA Jul 15, 2011


24. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 8 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011
15MG tablet, extended release Prescription ORAL AB Oct 28, 1998
60MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011
100MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011
200MG tablet, extended release Prescription ORAL AB Sep 15, 2000
80MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011
20MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011
50MG capsule, extended release Discontinued ORAL N/A Nov 10, 2011


25. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, extended release Prescription ORAL AB May 11, 2012
15MG tablet, extended release Prescription ORAL AB May 11, 2012
30MG tablet, extended release Prescription ORAL AB May 11, 2012
60MG tablet, extended release Prescription ORAL AB May 11, 2012
200MG tablet, extended release Prescription ORAL AB May 11, 2012


26. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 5 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet, extended release Discontinued ORAL N/A Aug 25, 2016
15MG tablet, extended release Discontinued ORAL N/A Aug 25, 2016
30MG tablet, extended release Discontinued ORAL N/A Aug 25, 2016
100MG tablet, extended release Discontinued ORAL N/A Aug 25, 2016
60MG tablet, extended release Discontinued ORAL N/A Aug 25, 2016


27. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 8 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
60MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
50MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
80MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
20MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
30MG capsule, extended release Discontinued ORAL N/A Dec 29, 2014
70MG capsule, extended release Discontinued ORAL N/A Jun 3, 2015
40MG capsule, extended release Discontinued ORAL N/A Jun 3, 2015


28. TRIS PHARMA INC

Tris Pharma Inc has filed for 3 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Tris Pharma Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML solution Prescription ORAL AA May 12, 2015
10MG/5ML solution Prescription ORAL AA May 12, 2015
20MG/5ML solution Discontinued ORAL N/A May 18, 2016


29. UPSHER SMITH LABS

Upsher Smith Laboratories Llc has filed for 8 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG capsule, extended release Prescription ORAL N/A Jun 3, 2013
10MG

(reference standard)

capsule, extended release Prescription ORAL N/A Jun 3, 2013
80MG capsule, extended release Prescription ORAL N/A Jun 3, 2013
60MG capsule, extended release Prescription ORAL N/A Jun 3, 2013
50MG capsule, extended release Prescription ORAL N/A Jun 3, 2013
30MG tablet Prescription ORAL AB Jul 22, 2019
100MG

(reference standard)

capsule, extended release Prescription ORAL N/A Jun 3, 2013
15MG tablet Prescription ORAL AB Jul 22, 2019


30. VISTAPHARM

Vistapharm Inc has filed for 2 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Vistapharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/5ML solution Discontinued ORAL N/A Jan 5, 2012
10MG/5ML solution Discontinued ORAL N/A Jan 5, 2012


31. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML injectable Discontinued INJECTION N/A Sep 30, 1991
0.5MG/ML injectable Discontinued INJECTION N/A Sep 30, 1991
100MG tablet, extended release Discontinued ORAL N/A Jan 30, 2001


32. WINDER LABS LLC

Winder Laboratoiries Llc has filed for 3 different strengths of generic version for Morphine Sulfate. Given below are the details of the strengths of this generic introduced by Winder Labs Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/5ML solution Prescription ORAL AA Feb 12, 2021
10MG/5ML solution Prescription ORAL AA Feb 12, 2021
100MG/5ML solution Prescription ORAL AA Feb 12, 2021