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Last Updated: November 30, 2021

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

DrugPatentWatch® Estimated Loss of Exclusivity Dates

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

Preferred citation:
Friedman, Yali, "37 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 LICART (diclofenac epolamine) generic drug versions launch?

Generic name: diclofenac epolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 19, 2021
Generic Entry Controlled by: FDA Regulatory Exclusivity

LICART is a drug marketed by Ibsa Inst Bio.

The generic ingredient in LICART is diclofenac epolamine. There are forty-seven drug master file entries for this API. Six 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
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: 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 forty-two 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
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: 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
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: 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 SPIRIVA RESPIMAT (tiotropium bromide) generic drug versions launch?

Generic name: tiotropium bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 04, 2022
Generic Entry Controlled by: Patent 7,988,001

Drug Price Trends for SPIRIVA RESPIMAT
SPIRIVA RESPIMAT is a drug marketed by Boehringer Ingelheim. There are seven patents protecting this drug.

This drug has one hundred and sixty-nine patent family members in forty-four countries.

See drug price trends for SPIRIVA RESPIMAT.

The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the tiotropium bromide profile page.

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

Generic name: cholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 17, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

CHOLBAM is a drug marketed by Travere.

This drug has one hundred and sixty-nine patent family members in forty-four 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
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: 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. Twelve 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.

When can JATENZO (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 27, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

JATENZO is a drug marketed by Clarus. There are five patents protecting this drug. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for JATENZO.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can SPIRIVA (tiotropium bromide) generic drug versions launch?

Generic name: tiotropium bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2022
Generic Entry Controlled by: Patent RE38912

Drug Price Trends for SPIRIVA
SPIRIVA is a drug marketed by Boehringer Ingelheim. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred patent family members in fifty-two countries. There has been litigation on patents covering SPIRIVA

See drug price trends for SPIRIVA.

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

When can ZOLADEX (goserelin acetate) generic drug versions launch?

Generic name: goserelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 13, 2022
Generic Entry Controlled by: Patent 4,100,274

ZOLADEX is a drug marketed by Tersera. There are three patents protecting this drug.

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

See drug price trends for ZOLADEX.

The generic ingredient in ZOLADEX is goserelin acetate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the goserelin acetate profile page.

When can COMBIGAN (brimonidine tartrate; timolol maleate) generic drug versions launch?

Generic name: brimonidine tartrate; timolol maleate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 19, 2022
Generic Entry Controlled by: Patent 7,320,976

Drug Price Trends for COMBIGAN
COMBIGAN is a drug marketed by Allergan. There are ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has twenty-six patent family members in nineteen countries. There has been litigation on patents covering COMBIGAN

See drug price trends for COMBIGAN.

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

When can IONSYS (fentanyl hydrochloride) generic drug versions launch?

Generic name: fentanyl hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 19, 2022
Generic Entry Controlled by: Patent 6,881,208

IONSYS is a drug marketed by The Medicines Co. There are nine patents protecting this drug.

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

The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this API. Additional details are available on the fentanyl hydrochloride profile page.

When can DUOBRII (halobetasol propionate; tazarotene) generic drug versions launch?

Generic name: halobetasol propionate; tazarotene
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 25, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for DUOBRII
DUOBRII is a drug marketed by Bausch. There are four patents protecting this drug.

This drug has forty-one patent family members in twenty-one countries. There has been litigation on patents covering DUOBRII

See drug price trends for DUOBRII.

The generic ingredient in DUOBRII is halobetasol propionate; tazarotene. There are nine drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the halobetasol propionate; tazarotene profile page.

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius Health Inc. There are four patents protecting this drug. One tentatively approved generic is ready to enter the market.

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

See drug price trends for TYMLOS.

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

When can FRAGMIN (dalteparin sodium) generic drug versions launch?

Generic name: dalteparin sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

FRAGMIN is a drug marketed by Pfizer.

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

See drug price trends for FRAGMIN.

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

When can ALIMTA (pemetrexed disodium) generic drug versions launch?

Generic name: pemetrexed disodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2022
Generic Entry Controlled by: Patent 5,344,932

ALIMTA is a drug marketed by Lilly. There is one patent protecting this drug and four Paragraph IV challenges. Five tentatively approved generics are ready to enter the market.

This drug has eighteen patent family members in eleven countries. There has been litigation on patents covering ALIMTA

See drug price trends for ALIMTA.

The generic ingredient in ALIMTA is pemetrexed disodium. 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 pemetrexed disodium profile page.

When can YOSPRALA (aspirin; omeprazole) generic drug versions launch?

Generic name: aspirin; omeprazole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2022
Generic Entry Controlled by: Patent 9,364,439

YOSPRALA is a drug marketed by Genus Lifesciences. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in twenty-three countries. There has been litigation on patents covering YOSPRALA

See drug price trends for YOSPRALA.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the aspirin; omeprazole profile page.

When can MYTESI (crofelemer) generic drug versions launch?

Generic name: crofelemer
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2022
Generic Entry Controlled by: Patent 7,341,744

Drug Price Trends for MYTESI
MYTESI is a drug marketed by Napo Pharms Inc. There are three patents protecting this drug.

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

See drug price trends for MYTESI.

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

When can ESKATA (hydrogen peroxide) generic drug versions launch?

Generic name: hydrogen peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 08, 2022
Generic Entry Controlled by: Patent 7,381,427

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

This drug has thirty-one patent family members in eighteen 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 LUSEDRA (fospropofol disodium) generic drug versions launch?

Generic name: fospropofol disodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2022
Generic Entry Controlled by: Patent 6,204,257

LUSEDRA is a drug marketed by Eisai Inc. There is one patent protecting this drug.

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

The generic ingredient in LUSEDRA is fospropofol disodium. Additional details are available on the fospropofol disodium profile page.

When can ULESFIA (benzyl alcohol) generic drug versions launch?

Generic name: benzyl alcohol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 11, 2022
Generic Entry Controlled by: Patent 6,793,931

ULESFIA is a drug marketed by Shionogi Inc. There are two patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering ULESFIA

The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this API. Additional details are available on the benzyl alcohol profile page.

When can GADAVIST (gadobutrol) generic drug versions launch?

Generic name: gadobutrol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

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

This drug has twenty-five patent family members in sixteen countries.

See drug price trends for GADAVIST.

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

When can IRESSA (gefitinib) generic drug versions launch?

Generic name: gefitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

IRESSA is a drug marketed by Astrazeneca.

This drug has twenty-five patent family members in sixteen countries.

See drug price trends for IRESSA.

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

When can FOLOTYN (pralatrexate) generic drug versions launch?

Generic name: pralatrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 16, 2022
Generic Entry Controlled by: Patent 6,028,071

FOLOTYN is a drug marketed by Acrotech. 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 forty-four patent family members in twenty-three countries. There has been litigation on patents covering FOLOTYN

See drug price trends for FOLOTYN.

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

When can IXEMPRA KIT (ixabepilone) generic drug versions launch?

Generic name: ixabepilone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 23, 2022
Generic Entry Controlled by: Patent 6,670,384

IXEMPRA KIT is a drug marketed by R-pharm Us Llc. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirteen patent family members in forty-five countries.

See drug price trends for IXEMPRA KIT.

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

When can ADDYI (flibanserin) generic drug versions launch?

Generic name: flibanserin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 01, 2022
Generic Entry Controlled by: Patent 7,420,057

ADDYI is a drug marketed by Sprout Pharms. There are four patents protecting this drug.

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

See drug price trends for ADDYI.

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

When can KEVEYIS (dichlorphenamide) generic drug versions launch?

Generic name: dichlorphenamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 07, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

KEVEYIS is a drug marketed by Strongbridge Us.

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

See drug price trends for KEVEYIS.

The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the dichlorphenamide profile page.

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

Generic name: formoterol fumarate; mometasone furoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 12, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

Drug Price Trends for DULERA
DULERA is a drug marketed by Organon.

This drug has eighty-two patent family members in thirty-one 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 KINEVAC (sincalide) generic drug versions launch?

Generic name: sincalide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 16, 2022
Generic Entry Controlled by: Patent 6,803,046

KINEVAC is a drug marketed by Bracco. There is one patent protecting this drug.

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

See drug price trends for KINEVAC.

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

When can ORAVIG (miconazole) generic drug versions launch?

Generic name: miconazole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 11, 2022
Generic Entry Controlled by: Patent 6,916,485

ORAVIG is a drug marketed by Galt Pharms. There are three patents protecting this drug.

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

See drug price trends for ORAVIG.

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

When can YONDELIS (trabectedin) generic drug versions launch?

Generic name: trabectedin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 23, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

YONDELIS is a drug marketed by Janssen Prods. There is one patent protecting this drug.

This drug has forty-four patent family members in thirty-six countries.

See drug price trends for YONDELIS.

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

When can TRI-LUMA (fluocinolone acetonide; hydroquinone; tretinoin) generic drug versions launch?

Generic name: fluocinolone acetonide; hydroquinone; tretinoin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 25, 2022
Generic Entry Controlled by: Patent 8,653,053

TRI-LUMA is a drug marketed by Galderma Labs Lp. There are four patents protecting this drug.

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

See drug price trends for TRI-LUMA.

The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.

When can LUMASON (sulfur hexafluoride lipid-type a microspheres) generic drug versions launch?

Generic name: sulfur hexafluoride lipid-type a microspheres
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

LUMASON is a drug marketed by Bracco. There are two patents protecting this drug.

This drug has eight patent family members in eight countries.

See drug price trends for LUMASON.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

When can XERESE (acyclovir; hydrocortisone) generic drug versions launch?

Generic name: acyclovir; hydrocortisone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2022
Generic Entry Controlled by: Patent 7,223,387

XERESE is a drug marketed by Bausch. There is one patent protecting this drug.

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

See drug price trends for XERESE.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the acyclovir; hydrocortisone profile page.

When can XOFIGO (radium ra-223 dichloride) generic drug versions launch?

Generic name: radium ra-223 dichloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 17, 2022
Generic Entry Controlled by: Patent 6,635,234

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

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

See drug price trends for XOFIGO.

The generic ingredient in XOFIGO is radium ra-223 dichloride. One supplier is listed for this generic product. Additional details are available on the radium ra-223 dichloride profile page.

When can GOPRELTO (cocaine hydrochloride) generic drug versions launch?

Generic name: cocaine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 14, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

GOPRELTO is a drug marketed by Genus Lifesciences. There are eleven patents protecting this drug. There has been litigation on patents covering GOPRELTO

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the cocaine hydrochloride profile page.

When can GIAPREZA (angiotensin ii acetate) generic drug versions launch?

Generic name: angiotensin ii acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2022
Generic Entry Controlled by: FDA Regulatory Exclusivity

GIAPREZA is a drug marketed by La Jolla Pharma. There are nine patents protecting this drug.

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

See drug price trends for GIAPREZA.

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

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