Bupivacaine Hydrochloride Patent Expiration

Bupivacaine Hydrochloride is Used for providing post-surgical analgesia through local anesthesia for up to 24 hours following implantation. It was first introduced by Hospira Inc in its drug Marcaine Hydrochloride Preservative Free on Approved Prior to Jan 1, 1982. Other drugs containing Bupivacaine Hydrochloride are Marcaine, Sensorcaine, Marcaine Hydrochloride, Bupivacaine Hydrochloride, Xaracoll, Bupivacaine Hydrochloride Kit. 14 different companies have introduced drugs containing Bupivacaine Hydrochloride.


Bupivacaine Hydrochloride Patents

Given below is the list of patents protecting Bupivacaine Hydrochloride, 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
Xaracoll US11746141 Modified collagen Jan 09, 2033 Innocoll Pharms
Xaracoll USRE47826 Drug delivery device for providing local analgesia, local anesthesia or nerve blockage May 20, 2029 Innocoll Pharms



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 Bupivacaine Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Bupivacaine Hydrochloride.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 05 Sep, 2023 US11746141
Recordation of Patent eGrant 05 Sep, 2023 US11746141
Recordation of Patent Grant Mailed 05 Sep, 2023 US11746141
Patent eGrant Notification 05 Sep, 2023 US11746141
Mail Patent eGrant Notification 05 Sep, 2023 US11746141
Email Notification 05 Sep, 2023 US11746141
Email Notification 18 Aug, 2023 US11746141
Issue Notification Mailed 16 Aug, 2023 US11746141
Dispatch to FDC 20 Jul, 2023 US11746141
Application Is Considered Ready for Issue 20 Jul, 2023 US11746141


Bupivacaine Hydrochloride's Family Patents

Family Patents

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Bupivacaine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Bupivacaine Hydrochloride. The first generic version for Bupivacaine Hydrochloride was by Hospira Inc and was approved on Feb 17, 1986. And the latest generic version is by Aspiro Pharma Ltd and was approved on Mar 27, 2024.

Given below is the list of companies who have filed for Bupivacaine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. ASPIRO

Aspiro Pharma Ltd has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Aspiro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25%

injectable Prescription INJECTION AP Mar 27, 2024
0.5%

injectable Prescription INJECTION AP Mar 27, 2024
0.75%

injectable Prescription INJECTION AP Mar 27, 2024


Manufacturing Plant Locations
New

Aspiro'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 Aspiro as present at those locations.

Country City Firm Name
India
Siddipet (Dist) Aspiro Pharma Limited





2. B BRAUN MEDICAL INC

B Braun Medical Inc has filed for 1 generic for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by B Braun Medical Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75%

injectable Prescription SPINAL AP Apr 2, 2019


Manufacturing Plant Locations
New

B Braun Medical Inc'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 B Braun Medical Inc as present at those locations.

Country City Firm Name
United States
Breinigsville B Braun Medical Inc





3. BAXTER HLTHCARE CORP

Baxter Healthcare Corp has filed for 1 generic for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75%

injectable Discontinued SPINAL N/A Jul 25, 2016





4. CIVICA

Civica Inc has filed for 1 generic for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Civica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5%

injectable Discontinued INJECTION N/A Feb 19, 2019





5. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. Out of these 0.75% version comes by the name BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25%

injectable Prescription INJECTION AP May 13, 2016
0.5%

injectable Prescription INJECTION AP May 13, 2016
0.75%

injectable Prescription INJECTION AP Nov 5, 2013


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





6. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. All of these versions come by the name SENSORCAINE. 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
0.25%

injectable Prescription INJECTION AP May 21, 1986
0.75%

injectable Discontinued SPINAL N/A Apr 15, 1987
0.5%

injectable Prescription INJECTION AP May 21, 1986


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
Skokie Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
North Andover Fresenius Kabi USA, LLC





7. HIKMA PHARMS

Hikma Pharmaceuticals has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. All of these versions come by the name BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Hikma Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25%

injectable Prescription INJECTION AP Feb 11, 2021
0.5%

injectable Prescription INJECTION AP Feb 11, 2021
0.75%

injectable Prescription INJECTION AP Feb 11, 2021





8. HOSPIRA

Hospira Inc has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5%

injectable Prescription INJECTION AP Mar 3, 1987
0.25%

injectable Discontinued INJECTION N/A Mar 3, 1987
0.75%

injectable Prescription SPINAL AP Dec 11, 1987


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Morgan Hill Hospira Inc
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Rocky Mount Hospira, Inc.
Mcpherson Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





9. HUONS

Huons Co Ltd has filed for 1 generic for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Huons.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75%

injectable Prescription SPINAL AP Dec 30, 2019


Manufacturing Plant Locations
New

Huons's manufacturing plants are situated in 1 country - Korea (the Republic of). Given below are the details of these plant locations as well as the firm names of Huons as present at those locations.

Country City Firm Name
Korea (the Republic of)
Jecheon Huons Co., Ltd. - Jecheon Factory





10. INTL MEDICATED

International Medicated Systems Ltd has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. All of these versions come by the name BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Intl Medicated.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75%

injectable Discontinued INJECTION N/A Jan 9, 2002
0.25%

injectable Discontinued INJECTION N/A Jan 9, 2002
0.5%

injectable Discontinued INJECTION N/A Jan 9, 2002





11. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25%

injectable Prescription INJECTION AP Dec 27, 2023
0.5%

injectable Prescription INJECTION AP Dec 27, 2023
0.75%

injectable Prescription INJECTION AP Dec 27, 2023





12. SOMERSET

Somerset Therapeutics Llc has filed for 2 different strengths of generic version for Bupivacaine Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25%

injectable Prescription INJECTION AP Nov 20, 2023
0.5%

injectable Prescription INJECTION AP Nov 20, 2023


Manufacturing Plant Locations
New

Somerset's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Somerset as present at those locations.

Country City Firm Name
United States
Fairfield Somerset Auction Company, LLC
Somerville Somerset Medical Center IRB
India
Bengaluru Somerset Therapeutics Limited





13. STERISCIENCE SPECLTS

Steriscience Specialities Pte Ltd has filed for 3 different strengths of generic version for Bupivacaine Hydrochloride. Out of these 0.75% version comes by the name BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Steriscience Speclts.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5%

injectable Prescription INJECTION AP Oct 18, 2011
0.25%

injectable Prescription INJECTION AP Oct 18, 2011
0.75%

injectable Prescription INJECTION AP Oct 18, 2011