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Last Updated: January 23, 2021

35 Drugs Facing Patent Expirations and Generic Entry in 2021 - 2022

Loss of Exclusivity / End of Market Exclusivity Period dates

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "35 Drugs Facing Patent Expirations and Generic Entry in 2021 - 2022" DrugPatentWatch.com thinkBiotech, 2021 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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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 FERAHEME (ferumoxytol) generic drug versions launch?

Generic name: ferumoxytol
Patent Expiration / Generic Entry Opportunity February 02, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

FERAHEME is a drug marketed by Amag Pharms Inc. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries. There has been litigation on patents covering FERAHEME

See drug price trends for FERAHEME.

The generic ingredient in FERAHEME is ferumoxytol. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ferumoxytol profile page.

When can FORTICAL (calcitonin salmon recombinant) generic drug versions launch?

Generic name: calcitonin salmon recombinant
Patent Expiration / Generic Entry Opportunity February 02, 2021
Generic Entry Controlled by: Patent 6,440,392

FORTICAL is a drug marketed by Upsher Smith Labs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in FORTICAL is calcitonin salmon recombinant. There are fourteen drug master file entries for this API. Additional details are available on the calcitonin salmon recombinant profile page.

When can CRIXIVAN (indinavir sulfate) generic drug versions launch?

Generic name: indinavir sulfate
Patent Expiration / Generic Entry Opportunity February 10, 2021
Generic Entry Controlled by: Patent 6,689,761

CRIXIVAN is a drug marketed by Merck Sharp Dohme. There is one patent protecting this drug.

This drug has forty-two patent family members in thirty-five countries.

See drug price trends for CRIXIVAN.

The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the indinavir sulfate profile page.

When can PREVANTICS MAXI SWABSTICK (chlorhexidine gluconate; isopropyl alcohol) generic drug versions launch?

Generic name: chlorhexidine gluconate; isopropyl alcohol
Patent Expiration / Generic Entry Opportunity February 14, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

PREVANTICS MAXI SWABSTICK is a drug marketed by Prof Dspls.

This drug has forty-two patent family members in thirty-five countries.

The generic ingredient in PREVANTICS MAXI SWABSTICK is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

When can CYSVIEW KIT (hexaminolevulinate hydrochloride) generic drug versions launch?

Generic name: hexaminolevulinate hydrochloride
Patent Expiration / Generic Entry Opportunity February 15, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

CYSVIEW KIT is a drug marketed by Photocure Asa. There are two patents protecting this drug.

This drug has twenty patent family members in fourteen countries.

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. One supplier is listed for this generic product. Additional details are available on the hexaminolevulinate hydrochloride profile page.

When can NORTHERA (droxidopa) generic drug versions launch?

Generic name: droxidopa
Patent Expiration / Generic Entry Opportunity February 18, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

NORTHERA is a drug marketed by Lundbeck Na Ltd. Two tentatively approved generics are ready to enter the market.

This drug has twenty patent family members in fourteen countries.

See drug price trends for NORTHERA.

The generic ingredient in NORTHERA is droxidopa. There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the droxidopa profile page.

When can ENJUVIA (estrogens, conjugated synthetic b) generic drug versions launch?

Generic name: estrogens, conjugated synthetic b
Patent Expiration / Generic Entry Opportunity March 08, 2021
Generic Entry Controlled by: Patent 6,660,726

ENJUVIA is a drug marketed by Aspen. There are two patents protecting this drug.

This drug has seventeen patent family members in nine countries.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this API. Additional details are available on the estrogens, conjugated synthetic b profile page.

When can LEVULAN (aminolevulinic acid hydrochloride) generic drug versions launch?

Generic name: aminolevulinic acid hydrochloride
Patent Expiration / Generic Entry Opportunity March 09, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

LEVULAN is a drug marketed by Dusa. There is one patent protecting this drug.

This drug has four patent family members in three countries. There has been litigation on patents covering LEVULAN

See drug price trends for LEVULAN.

The generic ingredient in LEVULAN is aminolevulinic acid 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 aminolevulinic acid hydrochloride profile page.

When can DORIBAX (doripenem) generic drug versions launch?

Generic name: doripenem
Patent Expiration / Generic Entry Opportunity March 30, 2021
Generic Entry Controlled by: Patent 5,317,016

DORIBAX is a drug marketed by Shionogi Inc. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in fifteen countries. There has been litigation on patents covering DORIBAX

See drug price trends for DORIBAX.

The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this API. Additional details are available on the doripenem profile page.

When can LIPIODOL (ethiodized oil) generic drug versions launch?

Generic name: ethiodized oil
Patent Expiration / Generic Entry Opportunity April 04, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

LIPIODOL is a drug marketed by Guerbet.

This drug has nineteen patent family members in fifteen countries.

See drug price trends for LIPIODOL.

The generic ingredient in LIPIODOL is ethiodized oil. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ethiodized oil profile page.

When can EXPAREL (bupivacaine) generic drug versions launch?

Generic name: bupivacaine
Patent Expiration / Generic Entry Opportunity April 06, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

EXPAREL is a drug marketed by Pacira Pharms Inc. There is one patent protecting this drug.

This drug has nineteen patent family members in nine countries.

See drug price trends for EXPAREL.

The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupivacaine profile page.

When can OPTISON (albumin human) generic drug versions launch?

Generic name: albumin human
Patent Expiration / Generic Entry Opportunity April 20, 2021
Generic Entry Controlled by: Patent 6,723,303

OPTISON is a drug marketed by Ge Healthcare. There is one patent protecting this drug.

This drug has forty patent family members in twenty-seven countries.

See drug price trends for OPTISON.

The generic ingredient in OPTISON is albumin human. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the albumin human profile page.

When can FIRMAGON (degarelix acetate) generic drug versions launch?

Generic name: degarelix acetate
Patent Expiration / Generic Entry Opportunity May 18, 2021
Generic Entry Controlled by: Patent 5,925,730

FIRMAGON is a drug marketed by Ferring. There are five patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in thirty-six countries. There has been litigation on patents covering FIRMAGON

See drug price trends for FIRMAGON.

The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this generic product. Additional details are available on the degarelix acetate profile page.

When can CONSENSI (amlodipine besylate; celecoxib) generic drug versions launch?

Generic name: amlodipine besylate; celecoxib
Patent Expiration / Generic Entry Opportunity May 31, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

CONSENSI is a drug marketed by Coeptis. There are three patents protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in CONSENSI is amlodipine besylate; celecoxib. There are fifty drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the amlodipine besylate; celecoxib profile page.

When can PERFOROMIST (formoterol fumarate) generic drug versions launch?

Generic name: formoterol fumarate
Patent Expiration / Generic Entry Opportunity June 22, 2021
Generic Entry Controlled by: Patent 8,623,922

Drug Price Trends for PERFOROMIST
PERFOROMIST is a drug marketed by Mylan Speclt. There are six patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has sixteen patent family members in nine countries. There has been litigation on patents covering PERFOROMIST

See drug price trends for PERFOROMIST.

The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the formoterol fumarate profile page.

When can NATROBA (spinosad) generic drug versions launch?

Generic name: spinosad
Patent Expiration / Generic Entry Opportunity July 02, 2021
Generic Entry Controlled by: Patent 7,030,095

Drug Price Trends for NATROBA
NATROBA is a drug marketed by Parapro Llc. There are two patents protecting this drug.

This drug has forty-eight patent family members in thirty 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 RESCULA (unoprostone isopropyl) generic drug versions launch?

Generic name: unoprostone isopropyl
Patent Expiration / Generic Entry Opportunity July 09, 2021
Generic Entry Controlled by: Patent 5,221,763

RESCULA is a drug marketed by Sucampo Pharma Llc. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in eighteen countries.

The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this API. Additional details are available on the unoprostone isopropyl profile page.

When can SMOFLIPID 20% (fish oil; medium chain triglycerides; olive oil; soybean oil) generic drug versions launch?

Generic name: fish oil; medium chain triglycerides; olive oil; soybean oil
Patent Expiration / Generic Entry Opportunity July 13, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

SMOFLIPID 20% is a drug marketed by Fresenius Kabi Usa.

This drug has twenty-one patent family members in eighteen countries.

The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.

When can INTELENCE (etravirine) generic drug versions launch?

Generic name: etravirine
Patent Expiration / Generic Entry Opportunity July 16, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for INTELENCE
INTELENCE is a drug marketed by Janssen R And D. There are three patents protecting this drug.

This drug has fifty-eight patent family members in thirty-five countries.

See drug price trends for INTELENCE.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the etravirine profile page.

When can ARNUITY ELLIPTA (fluticasone furoate) generic drug versions launch?

Generic name: fluticasone furoate
Patent Expiration / Generic Entry Opportunity August 03, 2021
Generic Entry Controlled by: Patent 7,101,866

Drug Price Trends for ARNUITY ELLIPTA
ARNUITY ELLIPTA is a drug marketed by Glaxosmithkline. There are eight patents protecting this drug.

This drug has two hundred and eighty-four patent family members in forty-one countries. There has been litigation on patents covering ARNUITY ELLIPTA

See drug price trends for ARNUITY ELLIPTA.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the fluticasone furoate profile page.

When can SOLUPREP (chlorhexidine gluconate; isopropyl alcohol) generic drug versions launch?

Generic name: chlorhexidine gluconate; isopropyl alcohol
Patent Expiration / Generic Entry Opportunity August 08, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

SOLUPREP is a drug marketed by 3m Health Care. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in SOLUPREP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

When can PREPOPIK (citric acid; magnesium oxide; sodium picosulfate) generic drug versions launch?

Generic name: citric acid; magnesium oxide; sodium picosulfate
Patent Expiration / Generic Entry Opportunity August 15, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

PREPOPIK is a drug marketed by Ferring Pharms Inc. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-one patent family members in twenty-four countries. There has been litigation on patents covering PREPOPIK

See drug price trends for PREPOPIK.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. 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; magnesium oxide; sodium picosulfate profile page.

When can SUTENT (sunitinib malate) generic drug versions launch?

Generic name: sunitinib malate
Patent Expiration / Generic Entry Opportunity August 15, 2021
Generic Entry Controlled by: Patent 6,573,293

Drug Price Trends for SUTENT
SUTENT is a drug marketed by Cppi Cv. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in forty-two countries.

See drug price trends for SUTENT.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the sunitinib malate profile page.

When can ADASUVE (loxapine) generic drug versions launch?

Generic name: loxapine
Patent Expiration / Generic Entry Opportunity October 26, 2021
Generic Entry Controlled by: Patent 8,173,107

ADASUVE is a drug marketed by Alexza Pharms. There are eighteen patents protecting this drug.

This drug has two hundred and twenty-six patent family members in twenty countries. There has been litigation on patents covering ADASUVE

See drug price trends for ADASUVE.

The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the loxapine profile page.

When can BROVANA (arformoterol tartrate) generic drug versions launch?

Generic name: arformoterol tartrate
Patent Expiration / Generic Entry Opportunity November 09, 2021
Generic Entry Controlled by: Patent 6,472,563

Drug Price Trends for BROVANA
BROVANA is a drug marketed by Sunovion. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering BROVANA

See drug price trends for BROVANA.

The generic ingredient in BROVANA is arformoterol tartrate. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the arformoterol tartrate profile page.

When can EOVIST (gadoxetate disodium) generic drug versions launch?

Generic name: gadoxetate disodium
Patent Expiration / Generic Entry Opportunity November 13, 2021
Generic Entry Controlled by: Patent 6,039,931

EOVIST is a drug marketed by Bayer Hlthcare. There is one patent protecting this drug.

This drug has thirty-three patent family members in twenty-four countries.

See drug price trends for EOVIST.

The generic ingredient in EOVIST is gadoxetate disodium. One supplier is listed for this generic product. Additional details are available on the gadoxetate disodium profile page.

When can AMTURNIDE (aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
Patent Expiration / Generic Entry Opportunity November 15, 2021
Generic Entry Controlled by: Patent 8,618,174

AMTURNIDE is a drug marketed by Novartis. There are two patents protecting this drug.

This drug has one hundred and twenty-five patent family members in thirty-one 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 NAVSTEL (calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate) generic drug versions launch?

Generic name: calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate
Patent Expiration / Generic Entry Opportunity November 29, 2021
Generic Entry Controlled by: Patent 7,084,130

NAVSTEL is a drug marketed by Alcon Pharms Ltd. There is one patent protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in NAVSTEL is calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this API. Additional details are available on the calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

When can LICART (diclofenac epolamine) generic drug versions launch?

Generic name: diclofenac epolamine
Patent Expiration / Generic Entry Opportunity December 19, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

LICART is a drug marketed by Ibsa Inst Bio.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in LICART is diclofenac epolamine. There are forty-seven drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the diclofenac epolamine profile page.

When can VAZALORE (aspirin) generic drug versions launch?

Generic name: aspirin
Patent Expiration / Generic Entry Opportunity December 19, 2021
Generic Entry Controlled by: Patent 9,351,984

VAZALORE is a drug marketed by Plx Pharma. There are five patents protecting this drug.

This drug has thirty-nine patent family members in eighteen countries.

The generic ingredient in VAZALORE is aspirin. There are twenty-two drug master file entries for this API. Additional details are available on the aspirin profile page.

When can FEMTRACE (estradiol acetate) generic drug versions launch?

Generic name: estradiol acetate
Patent Expiration / Generic Entry Opportunity December 21, 2021
Generic Entry Controlled by: Patent 6,962,908

FEMTRACE is a drug marketed by Apil. There are three patents protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this API. Additional details are available on the estradiol acetate profile page.

When can PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER (calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate) generic drug versions launch?

Generic name: calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate
Patent Expiration / Generic Entry Opportunity January 13, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER is a drug marketed by Baxter Hlthcare Corp.

This drug has eleven patent family members in ten countries.

The generic ingredient in PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

When can CHOLBAM (cholic acid) generic drug versions launch?

Generic name: cholic acid
Patent Expiration / Generic Entry Opportunity March 17, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

CHOLBAM is a drug marketed by Rtrx.

This drug has eleven patent family members in ten countries.

See drug price trends for CHOLBAM.

The generic ingredient in CHOLBAM is cholic acid. There are forty-four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the cholic acid profile page.

When can VIMPAT (lacosamide) generic drug versions launch?

Generic name: lacosamide
Patent Expiration / Generic Entry Opportunity March 17, 2022
Generic Entry Controlled by: Patent RE38551

Drug Price Trends for VIMPAT
VIMPAT is a drug marketed by Ucb Inc. There is one patent protecting this drug and three Paragraph IV challenges. Seven tentatively approved generics are ready to enter the market.

This drug has twenty-two patent family members in eleven countries. There has been litigation on patents covering VIMPAT

See drug price trends for VIMPAT.

The generic ingredient in VIMPAT is lacosamide. There are twenty-two drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the lacosamide profile page.

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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.