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Last Updated: August 10, 2020

27 Drugs Facing Patent Expirations and Generic Entry in 2020 - 2021

Loss of Exclusivity / End of Market Exclusivity Period dates

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Preferred citation:
Friedman, Yali, "27 Drugs Facing Patent Expirations and Generic Entry in 2020 - 2021" DrugPatentWatch.com thinkBiotech, 2020 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 BIDIL (hydralazine hydrochloride; isosorbide dinitrate) generic drug versions launch?

Generic name: hydralazine hydrochloride; isosorbide dinitrate
Patent Expiration / Generic Entry Opportunity September 08, 2020
Generic Entry Controlled by: Patent 6,465,463

BIDIL is a drug marketed by Arbor Pharms Llc. There are two patents protecting this drug.

This drug has four patent family members in four countries.

See drug price trends for BIDIL.

The generic ingredient in BIDIL is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

When can THALOMID (thalidomide) generic drug versions launch?

Generic name: thalidomide
Patent Expiration / Generic Entry Opportunity October 23, 2020
Generic Entry Controlled by: Patent 6,315,720

THALOMID is a drug marketed by Celgene. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has forty-seven 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 ESKATA (hydrogen peroxide) generic drug versions launch?

Generic name: hydrogen peroxide
Patent Expiration / Generic Entry Opportunity December 14, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity

ESKATA is a drug marketed by Aclaris. There are five patents protecting this drug.

This drug has twenty-eight patent family members in fifteen countries.

The generic ingredient in ESKATA is hydrogen peroxide. There are fifty-three drug master file entries for this API. Additional details are available on the hydrogen peroxide profile page.

When can DULERA (formoterol fumarate; mometasone furoate) generic drug versions launch?

Generic name: formoterol fumarate; mometasone furoate
Patent Expiration / Generic Entry Opportunity December 20, 2020
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for DULERA
DULERA is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

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

See drug price trends for DULERA.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. 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; mometasone furoate profile page.

When can BRIDION (sugammadex sodium) generic drug versions launch?

Generic name: sugammadex sodium
Patent Expiration / Generic Entry Opportunity January 27, 2021
Generic Entry Controlled by: Patent RE44733

BRIDION is a drug marketed by Organon Sub Merck. There are three patents protecting this drug.

This drug has fifty-six patent family members in thirty countries. There has been litigation on patents covering BRIDION

See drug price trends for BRIDION.

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

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 RE43580

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 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. One tentatively approved generic is 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 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 ERAXIS (anidulafungin) generic drug versions launch?

Generic name: anidulafungin
Patent Expiration / Generic Entry Opportunity April 12, 2021
Generic Entry Controlled by: Patent 5,965,525

ERAXIS is a drug marketed by Vicuron. There are three patents protecting this drug.

This drug has sixty-seven patent family members in twenty-nine 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 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 BRIVIACT (brivaracetam) generic drug versions launch?

Generic name: brivaracetam
Patent Expiration / Generic Entry Opportunity May 12, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for BRIVIACT
BRIVIACT is a drug marketed by Ucb Inc. There are three patents protecting this drug.

This drug has one hundred and forty-six patent family members in forty-two countries.

See drug price trends for BRIVIACT.

The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this generic product. Additional details are available on the brivaracetam 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 three patents protecting this drug.

This drug has one hundred and thirty-six patent family members in thirty-six countries.

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 two 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 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 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. One tentatively approved generic is ready to enter the market.

This drug has eighty patent family members in forty-two countries. There has been litigation on patents covering SUTENT

See drug price trends for SUTENT.

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

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