United States: These 31 Drugs Face Patent Expirations and Generic Entry From 2023 - 2024
DrugPatentWatch® Estimated Loss of Exclusivity Dates in the United States
The content of this page is licensed under a Creative Commons Attribution 4.0 International License.
Generic Entry Dates in Other Countries
Friedman, Yali, "United States: These 31 Drugs Face Patent Expirations and Generic Entry From 2023 - 2024" DrugPatentWatch.com thinkBiotech, 2023 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
Media collateral
These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can DEFITELIO (defibrotide sodium) generic drug versions launch?
Generic name: defibrotide sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
DEFITELIO is a drug marketed by Jazz Pharms Inc. There are two patents protecting this drug.
This drug has twenty-five patent family members in sixteen countries.
See drug price trends for DEFITELIO.
The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this generic product. Additional details are available on the defibrotide sodium profile page.
When can TARGINIQ (naloxone hydrochloride; oxycodone hydrochloride) generic drug versions launch?
Generic name: naloxone hydrochloride; oxycodone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 04, 2023
Generic Entry Controlled by: United States Patent Patent 9,907,793
TARGINIQ is a drug marketed by Purdue Pharma Lp. There are fifteen patents protecting this drug.
This drug has three hundred and five patent family members in forty-four countries. There has been litigation on patents covering TARGINIQ
The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this API. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.
When can PROVAYBLUE (methylene blue) generic drug versions launch?
Generic name: methylene blue
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 08, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
PROVAYBLUE is a drug marketed by Provepharm Sas.
This drug has three hundred and five patent family members in forty-four countries.
See drug price trends for PROVAYBLUE.
The generic ingredient in PROVAYBLUE is methylene blue. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the methylene blue profile page.
When can AMTURNIDE (aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide) generic drug versions launch?
Generic name: aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2023
Generic Entry Controlled by: United States Patent Patent 8,183,295
AMTURNIDE is a drug marketed by Novartis. There is one patent protecting this drug.
This drug has thirty-two patent family members in twenty-four countries.
The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.
When can LUCEMYRA (lofexidine hydrochloride) generic drug versions launch?
Generic name: lofexidine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
This drug has thirty-two patent family members in twenty-four countries.
See drug price trends for LUCEMYRA.
The generic ingredient in LUCEMYRA is lofexidine hydrochloride. One supplier is listed for this generic product. Additional details are available on the lofexidine hydrochloride profile page.
When can PHEXXI (citric acid; lactic acid; potassium bitartrate) generic drug versions launch?
Generic name: citric acid; lactic acid; potassium bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 22, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
This drug has sixty-three patent family members in twenty-three countries.
See drug price trends for PHEXXI.
The generic ingredient in PHEXXI is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.
When can VISTOGARD (uridine triacetate) generic drug versions launch?
Generic name: uridine triacetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2023
Generic Entry Controlled by: United States Patent Patent 6,258,795
VISTOGARD is a drug marketed by Wellstat Therap. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the uridine triacetate profile page.
When can XURIDEN (uridine triacetate) generic drug versions launch?
Generic name: uridine triacetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2023
Generic Entry Controlled by: United States Patent Patent 6,258,795
XURIDEN is a drug marketed by Wellstat Therap. There is one patent protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the uridine triacetate profile page.
When can PHOTREXA (riboflavin 5'-phosphate sodium) generic drug versions launch?
Generic name: riboflavin 5'-phosphate sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 15, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
PHOTREXA is a drug marketed by Glaukos.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
See drug price trends for PHOTREXA.
The generic ingredient in PHOTREXA is riboflavin 5'-phosphate sodium. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the riboflavin 5'-phosphate sodium profile page.
When can MOZOBIL (plerixafor) generic drug versions launch?
Generic name: plerixafor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 22, 2023
Generic Entry Controlled by: United States Patent Patent 7,897,590
MOZOBIL is a drug marketed by Genzyme. There are two patents protecting this drug and one Paragraph IV challenge. Four tentatively approved generics are ready to enter the market.
This drug has fifty-two patent family members in twenty-seven countries. There has been litigation on patents covering MOZOBIL
See drug price trends for MOZOBIL.
The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the plerixafor profile page.
When can BREZTRI AEROSPHERE (budesonide; formoterol fumarate; glycopyrrolate) generic drug versions launch?
Generic name: budesonide; formoterol fumarate; glycopyrrolate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 23, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
BREZTRI AEROSPHERE is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug.
This drug has two hundred patent family members in thirty-three countries.
The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.
When can CYSTADROPS (cysteamine hydrochloride) generic drug versions launch?
Generic name: cysteamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 19, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
CYSTADROPS is a drug marketed by Recordati Rare.
This drug has two hundred patent family members in thirty-three countries.
See drug price trends for CYSTADROPS.
The generic ingredient in CYSTADROPS is cysteamine hydrochloride. There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the cysteamine hydrochloride profile page.
When can VYVANSE (lisdexamfetamine dimesylate) generic drug versions launch?
Generic name: lisdexamfetamine dimesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 24, 2023
Generic Entry Controlled by: United States Patent Patent 7,655,630
This drug has one hundred and forty-eight patent family members in twenty-seven countries. There has been litigation on patents covering VYVANSE
See drug price trends for VYVANSE.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is listed for this generic product. Additional details are available on the lisdexamfetamine dimesylate profile page.
When can TYZEKA (telbivudine) generic drug versions launch?
Generic name: telbivudine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 11, 2023
Generic Entry Controlled by: United States Patent Patent 6,569,837
TYZEKA is a drug marketed by Novartis. There are two patents protecting this drug.
This drug has eleven patent family members in seven countries.
The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this API. Additional details are available on the telbivudine profile page.
When can ERAXIS (anidulafungin) generic drug versions launch?
Generic name: anidulafungin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
ERAXIS is a drug marketed by Vicuron Holdings.
This drug has eleven patent family members in seven countries.
See drug price trends for ERAXIS.
The generic ingredient in ERAXIS is anidulafungin. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the anidulafungin profile page.
When can VOTRIENT (pazopanib hydrochloride) generic drug versions launch?
Generic name: pazopanib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 19, 2023
Generic Entry Controlled by: United States Patent Patent 7,105,530
VOTRIENT is a drug marketed by Novartis. There is one patent protecting this drug.
This drug has forty patent family members in twenty-five countries.
See drug price trends for VOTRIENT.
The generic ingredient in VOTRIENT is pazopanib hydrochloride. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pazopanib hydrochloride profile page.
When can SUTAB (COPACKAGED) (magnesium sulfate; potassium chloride; sodium sulfate) generic drug versions launch?
Generic name: magnesium sulfate; potassium chloride; sodium sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
SUTAB (COPACKAGED) is a drug marketed by
This drug has forty patent family members in twenty-five countries.
The generic ingredient in SUTAB (COPACKAGED) is magnesium sulfate; potassium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the magnesium sulfate; potassium chloride; sodium sulfate profile page.
When can XOPENEX HFA (levalbuterol tartrate) generic drug versions launch?
Generic name: levalbuterol tartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2023
Generic Entry Controlled by: United States Patent Patent 8,765,153
This drug has thirty-six patent family members in eighteen countries. There has been litigation on patents covering XOPENEX HFA
See drug price trends for XOPENEX HFA.
The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the levalbuterol tartrate profile page.
When can THALOMID (thalidomide) generic drug versions launch?
Generic name: thalidomide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 09, 2023
Generic Entry Controlled by: United States Patent Patent 7,230,012
THALOMID is a drug marketed by Celgene. There is one patent protecting this drug and three Paragraph IV challenges.
This drug has twenty-nine patent family members in nineteen countries. There has been litigation on patents covering THALOMID
See drug price trends for THALOMID.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the thalidomide profile page.
When can MOTEGRITY (prucalopride succinate) generic drug versions launch?
Generic name: prucalopride succinate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 14, 2023
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
This drug has twenty-nine patent family members in nineteen countries.
See drug price trends for MOTEGRITY.
The generic ingredient in MOTEGRITY is prucalopride succinate. One supplier is listed for this generic product. Additional details are available on the prucalopride succinate profile page.
When can RAPIVAB (peramivir) generic drug versions launch?
Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2023
Generic Entry Controlled by: United States Patent Patent 6,562,861
RAPIVAB is a drug marketed by Biocryst. There are three patents protecting this drug.
This drug has seventy patent family members in twenty-eight countries.
See drug price trends for RAPIVAB.
The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.
When can AURYXIA (ferric citrate) generic drug versions launch?
Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 18, 2024
Generic Entry Controlled by: United States Patent Patent 9,328,133
This drug has one hundred and thirty-seven patent family members in twenty-six countries. There has been litigation on patents covering AURYXIA
See drug price trends for AURYXIA.
The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ferric citrate profile page.
When can SPRAVATO (esketamine hydrochloride) generic drug versions launch?
Generic name: esketamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 05, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
SPRAVATO is a drug marketed by Janssen Pharms. There are six patents protecting this drug.
This drug has forty-one patent family members in nineteen countries.
See drug price trends for SPRAVATO.
The generic ingredient in SPRAVATO is esketamine hydrochloride. One supplier is listed for this generic product. Additional details are available on the esketamine hydrochloride profile page.
When can EXPAREL (bupivacaine) generic drug versions launch?
Generic name: bupivacaine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 22, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
EXPAREL is a drug marketed by Pacira Pharms Inc. There are eight patents protecting this drug.
This drug has five patent family members in four countries. There has been litigation on patents covering EXPAREL
See drug price trends for EXPAREL.
The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the bupivacaine profile page.
When can CONTRAVE (bupropion hydrochloride; naltrexone hydrochloride) generic drug versions launch?
Generic name: bupropion hydrochloride; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2024
Generic Entry Controlled by: United States Patent Patent 11,278,544
CONTRAVE is a drug marketed by Nalpropion. There are twenty patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifty-seven patent family members in forty-three countries. There has been litigation on patents covering CONTRAVE
See drug price trends for CONTRAVE.
The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.
When can NATROBA (spinosad) generic drug versions launch?
Generic name: spinosad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
This drug has thirty-seven patent family members in twenty-eight countries.
See drug price trends for NATROBA.
The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this API. Two suppliers are listed for this generic product. Additional details are available on the spinosad profile page.
When can RYDAPT (midostaurin) generic drug versions launch?
Generic name: midostaurin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
RYDAPT is a drug marketed by Novartis. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.
This drug has sixty-two patent family members in twenty-seven countries. There has been litigation on patents covering RYDAPT
See drug price trends for RYDAPT.
The generic ingredient in RYDAPT is midostaurin. One supplier is listed for this generic product. Additional details are available on the midostaurin profile page.
When can TRALEMENT (cupric sulfate; manganese sulfate; selenious acid; zinc sulfate) generic drug versions launch?
Generic name: cupric sulfate; manganese sulfate; selenious acid; zinc sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 30, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
TRALEMENT is a drug marketed by Am Regent.
This drug has sixty-two patent family members in twenty-seven countries.
See drug price trends for TRALEMENT.
The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this generic product. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.
When can RADICAVA (edaravone) generic drug versions launch?
Generic name: edaravone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 05, 2024
Generic Entry Controlled by: United States FDA Regulatory Exclusivity
RADICAVA is a drug marketed by Mitsubishi Tanabe. There are three patents protecting this drug.
This drug has sixty-two patent family members in twenty-seven countries.
See drug price trends for RADICAVA.
The generic ingredient in RADICAVA is edaravone. One supplier is listed for this generic product. Additional details are available on the edaravone profile page.
When can OMONTYS (peginesatide acetate) generic drug versions launch?
Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 12, 2024
Generic Entry Controlled by: United States Patent Patent 7,084,245
OMONTYS is a drug marketed by Takeda Pharms Usa. There are six patents protecting this drug.
This drug has one hundred and fourteen patent family members in thirty-four countries.
The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.
When can CHILDREN'S ADVIL ALLERGY SINUS (chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride) generic drug versions launch?
Generic name: chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 25, 2024
Generic Entry Controlled by: United States Patent Patent 10,238,640
CHILDREN'S ADVIL ALLERGY SINUS is a drug marketed by Glaxosmithkline. There is one patent protecting this drug.
This drug has nine patent family members in eight countries.
The generic ingredient in CHILDREN'S ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.
DrugPatentWatch cited by CNN, NEJM, Nature Journals, and more …

Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.