Octreotide Acetate Patent Expiration

Octreotide Acetate was first introduced by Novartis Pharmaceuticals Corp in its drug Sandostatin on Oct 21, 1988. Other drugs containing Octreotide Acetate are Mycapssa, Bynfezia Pen, Sandostatin Lar. 14 different companies have introduced drugs containing Octreotide Acetate.


Octreotide Acetate Patents

Given below is the list of patents protecting Octreotide Acetate, 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
Bynfezia Pen US10342850 Octreotide injection May 15, 2038 Sun Pharm
Mycapssa US10238709 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US10695397 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US11052126 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US11141457 Oral octreotide therapy and contraceptive methods Dec 28, 2040 Chiesi
Mycapssa US11338011 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US11510963 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US11857595 Method of treating diseases Feb 03, 2036 Chiesi
Mycapssa US11890316 Oral octreotide therapy and contraceptive methods Dec 28, 2040 Chiesi
Mycapssa US11969471 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Mycapssa US11986529 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Mycapssa US8329198 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Mycapssa US8535695 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Mycapssa US9265812 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Mycapssa US9566246 Pharmaceutical compositions and related methods of delivery Sep 17, 2029 Chiesi
Sandostatin US5753618 Somatostatin analogue composition and use in treating breast cancer May 19, 2015

(Expired)

Novartis
Sandostatin US5753618

(Pediatric)

Somatostatin analogue composition and use in treating breast cancer Nov 19, 2015

(Expired)

Novartis
Sandostatin Lar US5538739 Sustained release formulations of water soluble peptides Jul 23, 2013

(Expired)

Novartis
Sandostatin Lar US5538739

(Pediatric)

Sustained release formulations of water soluble peptides Jan 23, 2014

(Expired)

Novartis
Sandostatin Lar US5639480 Sustained release formulations of water soluble peptides Jun 17, 2014

(Expired)

Novartis
Sandostatin Lar US5639480

(Pediatric)

Sustained release formulations of water soluble peptides Dec 17, 2014

(Expired)

Novartis
Sandostatin Lar US5688530 Sustained release formulations of water soluble peptides Nov 18, 2014

(Expired)

Novartis
Sandostatin Lar US5688530

(Pediatric)

Sustained release formulations of water soluble peptides May 18, 2015

(Expired)

Novartis
Sandostatin Lar US5922338 Polyol esters, their preparation and use in depot forms of pharmacologically active agents Jul 13, 2016

(Expired)

Novartis
Sandostatin Lar US5922338

(Pediatric)

Polyol esters, their preparation and use in depot forms of pharmacologically active agents Jan 13, 2017

(Expired)

Novartis
Sandostatin Lar US5922682 Polyol esters, their preparation and use in depot forms of pharmacologically active agents Jul 13, 2016

(Expired)

Novartis
Sandostatin Lar US5922682

(Pediatric)

Polyol esters, their preparation and use in depot forms of pharmacologically active agents Jan 13, 2017

(Expired)

Novartis


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Octreotide Acetate Generics

Several generic applications have been filed for Octreotide Acetate. The first generic version for Octreotide Acetate was by West-Ward Pharmaceuticals International Ltd and was approved on Mar 28, 2005. And the latest generic version is by Hainan Shuangcheng Pharmaceuticals Co Ltd and was approved on May 2, 2024.

Given below is the list of companies who have filed for Octreotide Acetate generic.


1. WOCKHARDT USA

Wockhardt Usa Inc has filed for 5 different strengths of generic version for Octreotide Acetate. Out of these eq 0.1mg base/ml version comes by the name OCTREOTIDE ACETATE PRESERVATIVE FREE, eq 0.05mg base/ml version comes by the name OCTREOTIDE ACETATE PRESERVATIVE FREE, eq 0.5mg base/ml version comes by the name OCTREOTIDE ACETATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Wockhardt Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.1MG BASE/ML injectable Discontinued INJECTION N/A May 11, 2011
EQ 0.2MG BASE/ML injectable Discontinued INJECTION N/A May 11, 2011
EQ 1MG BASE/ML injectable Discontinued INJECTION N/A May 11, 2011
EQ 0.05MG BASE/ML injectable Discontinued INJECTION N/A May 11, 2011
EQ 0.5MG BASE/ML injectable Discontinued INJECTION N/A May 11, 2011


2. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 4 different strengths of generic version for Octreotide Acetate. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE/ML injectable Prescription INJECTION AP Jun 13, 2023
EQ 1MG BASE/ML injectable Prescription INJECTION AP Jun 13, 2023
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Jun 22, 2023
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Jun 22, 2023


3. SUN PHARM INDS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML injectable Discontinued INJECTION N/A Mar 4, 2008
EQ 0.1MG BASE/ML injectable Discontinued INJECTION N/A Mar 4, 2008
EQ 0.5MG BASE/ML injectable Discontinued INJECTION N/A Mar 4, 2008
EQ 0.2MG BASE/ML injectable Discontinued INJECTION N/A Mar 4, 2008
EQ 1MG BASE/ML injectable Discontinued INJECTION N/A Mar 4, 2008


4. HERITAGE PHARMS

Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc has filed for 5 different strengths of generic version for Octreotide Acetate. Given below are the details of the strengths of this generic introduced by Heritage Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE/ML injectable Prescription INJECTION AP Sep 7, 2018
EQ 1MG BASE/ML injectable Prescription INJECTION AP Sep 7, 2018
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Dec 27, 2018
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Dec 27, 2018
EQ 0.05MG BASE/ML injectable Prescription INJECTION AP Dec 27, 2018


5. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 3 different strengths of generic version for Octreotide Acetate. All of these versions come by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE). Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2011
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2011
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2011


6. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 5 different strengths of generic version for Octreotide Acetate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Oct 3, 2005
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Oct 3, 2005
EQ 0.05MG BASE/ML injectable Prescription INJECTION AP Oct 3, 2005
EQ 0.2MG BASE/ML injectable Prescription INJECTION AP Nov 21, 2005
EQ 1MG BASE/ML injectable Prescription INJECTION AP Nov 21, 2005


7. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 5 different strengths of generic version for Octreotide Acetate. Out of these eq 0.5mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.1mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.05mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE). 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
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2006
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2006
EQ 0.05MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2006
EQ 1MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2006
EQ 0.2MG BASE/ML injectable Prescription INJECTION AP Feb 10, 2006


8. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Octreotide Acetate. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 20MG BASE/VIAL injectable Prescription INJECTION AB Dec 5, 2023
EQ 10MG BASE/VIAL injectable Prescription INJECTION AB Dec 5, 2023
EQ 30MG BASE/VIAL injectable Prescription INJECTION AB Dec 5, 2023


9. SHUANGCHENG

Hainan Shuangcheng Pharmaceuticals Co Ltd has filed for 1 generic for Octreotide Acetate. Given below are the details of the strengths of this generic introduced by Shuangcheng.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP May 2, 2024


10. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 5 different strengths of generic version for Octreotide Acetate. Out of these eq 0.05mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.1mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.5mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE). Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE/ML injectable Prescription INJECTION AP Nov 12, 2013
EQ 0.05MG BASE/ML injectable Prescription INJECTION AP Nov 12, 2013
EQ 0.1MG BASE/ML injectable Prescription INJECTION AP Nov 12, 2013
EQ 0.5MG BASE/ML injectable Prescription INJECTION AP Nov 12, 2013
EQ 1MG BASE/ML injectable Prescription INJECTION AP Nov 12, 2013


11. WEST-WARD PHARMS INT

West-ward Pharmaceuticals International Ltd has filed for 5 different strengths of generic version for Octreotide Acetate. Out of these eq 0.1mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.5mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE), eq 0.05mg base/ml version comes by the name OCTREOTIDE ACETATE (PRESERVATIVE FREE). Given below are the details of the strengths of this generic introduced by West-ward Pharms Int.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.1MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Mar 28, 2005
EQ 0.5MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Mar 28, 2005
EQ 0.05MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Mar 28, 2005
EQ 0.2MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Apr 8, 2005
EQ 1MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Apr 8, 2005