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Last Updated: September 25, 2022

BARHEMSYS Drug Patent Profile


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When do Barhemsys patents expire, and when can generic versions of Barhemsys launch?

Barhemsys is a drug marketed by Acacia and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-three patent family members in twenty-six countries.

The generic ingredient in BARHEMSYS is amisulpride. There are four drug master file entries for this compound. Additional details are available on the amisulpride profile page.

DrugPatentWatch® Generic Entry Outlook for Barhemsys

Barhemsys will be eligible for patent challenges on February 26, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BARHEMSYS
International Patents:63
US Patents:5
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 125
Patent Applications: 3,934
What excipients (inactive ingredients) are in BARHEMSYS?BARHEMSYS excipients list
DailyMed Link:BARHEMSYS at DailyMed
Drug patent expirations by year for BARHEMSYS
DrugPatentWatch® Estimated Generic Entry Opportunity Date for BARHEMSYS
Generic Entry Date for BARHEMSYS*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for BARHEMSYS

US Patents and Regulatory Information for BARHEMSYS

BARHEMSYS is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BARHEMSYS is See Plans and Pricing.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BARHEMSYS

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Rescue treatment of post operative nausea and vomiting
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

Use of amisulpride as an anti-emetic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

FDA Regulatory Exclusivity protecting BARHEMSYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for BARHEMSYS

See the table below for patents covering BARHEMSYS around the world.

Country Patent Number Title Estimated Expiration
Canada 3052535 TRAITEMENT D'URGENCE CONTRE LA NAUSEE ET LE VOMISSEMENT POSTOPERATOIRES (RESCUE TREATMENT OF POST OPERATIVE NAUSEA AND VOMITING) See Plans and Pricing
Spain 2665418 See Plans and Pricing
United Kingdom 201004020 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.