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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 Bynfezia Pen, Sandostatin Lar, Mycapssa. 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
Mycapssa US11141457 Oral octreotide therapy and contraceptive methods Dec 28, 2040 Chiesi
Mycapssa US11890316 Oral octreotide therapy and contraceptive methods Dec 28, 2040 Chiesi
Bynfezia Pen US11052196 Method of injecting octreotide acetate into the body Nov 03, 2040 Sun Pharm
Bynfezia Pen US11246991 Electrolysis-resistant coupling assembly for valves Nov 03, 2040 Sun Pharm
Bynfezia Pen US11534553 Method of injecting octreotide acetate into the body Nov 03, 2040 Sun Pharm
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 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 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 Lar US5922338

(Pediatric)

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

(Expired)

 Novartis
Sandostatin Lar US5922682

(Pediatric)

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

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

(Expired)

 Novartis
Sandostatin US5753618

(Pediatric)

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

(Expired)

 Novartis
Sandostatin US5753618 Somatostatin analogue composition and use in treating breast cancer May 19, 2015

(Expired)

 Novartis
Sandostatin Lar US5688530

(Pediatric)

 Sustained release formulations of water soluble peptides May 18, 2015

(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 US5639480 Sustained release formulations of water soluble peptides Jun 17, 2014

(Expired)

 Novartis
Sandostatin Lar US5538739

(Pediatric)

 Sustained release formulations of water soluble peptides Jan 23, 2014

(Expired)

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

(Expired)

 Novartis



Octreotide Acetate's Family Patents

Family Patents

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Octreotide Acetate Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Lake Zurich Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC





2. GLAND

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.

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


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Malur Gland Chemicals Pvt Ltd.
Hyderabad Gland Pharma Limited
Aurangabad Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Parawada, Visakhapatnam Gland Pharma Limited
Sriperumbudur Gland Chemical Private Limited





3. HERITAGE

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.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/ML

injectable Prescription INJECTION AP Sep 7, 2018
EQ 0.2MG BASE/ML

injectable Prescription INJECTION AP Sep 7, 2018
EQ 0.05MG BASE/ML

injectable Prescription INJECTION AP Dec 27, 2018
EQ 0.1MG BASE/ML

injectable Prescription INJECTION AP Dec 27, 2018
EQ 0.5MG BASE/ML

injectable Prescription INJECTION AP Dec 27, 2018


Manufacturing Plant Locations
New

Heritage's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Heritage as present at those locations.

Country City Firm Name
United States
Vanlue Heritage Cooperative
Dola Heritage Cooperative Inc
Beloit Heritage Cooperative
London Heritage Cooperative Inc.
Woodsfield Heritage Cooperative
Caldwell Heritage Country Store-Heritage Cooperative
De Graff Heritage Cooperative Inc
New Philadelphia Heritage Cooperative
Upper Sandusky Heritage Cooperative
Ada Heritage Cooperative Inc
Springfield Heritage Cooperative, Inc
Alger Heritage Cooperative
Richwood Heritage Cooperative, Inc
Cairo Heritage Cooperative
Morgantown Heritage Animal Hospital
South Burlington Heritage Aviation
Fletcher Heritage Cooperative Inc
Kenton Heritage Cooperative
Fort Scott Heritage Acres Farm
Canfield Heritage Cooperative
Mc Cutchenville Heritage Cooperative, Inc
Plain City Heritage Cooperative Inc.
Waterford Heritage Cooperative
West Mansfield Heritage Cooperative Inc.
Chino Heritage #2
Urbana Heritage Cooperative Inc
Lisbon Heritage Cooperative, Inc.
London Heritage Cooperative, Inc
West Liberty Heritage Cooperative, Inc
Minneapolis Heritage Deli Provisions, LLC
Van Nuys Heritage Candy Company, Inc.
Middlebury Heritage Acres
Sacramento Heritage Baking Company Inc.





4. 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





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


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





6. 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





7. 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 Discontinued INJECTION N/A May 2, 2024





8. 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





9. 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





10. 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





11. 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