Spain: These 30 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026
DrugPatentWatch® Estimated Loss of Exclusivity Dates in Spain
Generic Entry Dates in Other Countries
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.
Summary: Spain: These 30 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026
| Tradename | Ingredient | Estimated Entry Opportunity Date |
|---|---|---|
| CREON | pancrelipase (amylase;lipase;protease) | 2026-08-15 |
| EMBEDA | morphine sulfate; naltrexone hydrochloride | 2026-06-19 |
| XALKORI | crizotinib | 2026-11-23 |
| BYDUREON | exenatide synthetic | 2026-06-28 |
| EPIDUO | adapalene; benzoyl peroxide | 2026-07-13 |
| >Tradename | >Ingredient | >Estimated Entry Opportunity Date |
Details: Spain: These 30 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026
When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?
Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 15, 2026
Generic Entry Controlled by: Spain Patent 2,341,284
CREON is a drug marketed by
See drug price trends for CREON.
The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.
When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?
Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,600,141
EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.
This drug has seventy-four patent family members in twenty-three countries.
See drug price trends for EMBEDA.
The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.
When can XALKORI (crizotinib) generic drug versions launch?
Generic name: crizotinib
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 23, 2026
Generic Entry Controlled by: Spain Patent 2,402,419
XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.
This drug has one hundred and fifty-two patent family members in forty-eight countries.
See drug price trends for XALKORI.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this generic product. Additional details are available on the crizotinib profile page.
When can BYDUREON (exenatide synthetic) generic drug versions launch?
Generic name: exenatide synthetic
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 28, 2026
Generic Entry Controlled by: Spain Patent 2,521,665

This drug has three hundred and forty-six patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON
See drug price trends for BYDUREON.
The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.
When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?
Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: July 13, 2026
Generic Entry Controlled by: Spain Patent 2,703,505

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO
See drug price trends for EPIDUO.
The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.
When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?
Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: July 13, 2026
Generic Entry Controlled by: Spain Patent 2,703,505

See drug price trends for EPIDUO FORTE.
The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.
When can PICATO (ingenol mebutate) generic drug versions launch?
Generic name: ingenol mebutate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 18, 2026
Generic Entry Controlled by: Spain Patent 2,461,315

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO
See drug price trends for PICATO.
The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.
When can SALONPAS (menthol; methyl salicylate) generic drug versions launch?
Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 04, 2026
Generic Entry Controlled by: Spain Patent 2,755,027
SALONPAS is a drug marketed by Hisamitsu Pharm Co. There are two patents protecting this drug.
This drug has twenty patent family members in sixteen countries.
The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.
When can LASTACAFT (alcaftadine) generic drug versions launch?
Generic name: alcaftadine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: March 31, 2026
Generic Entry Controlled by: Spain Patent 2,594,655

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT
See drug price trends for LASTACAFT.
The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.
When can LYRICA CR (pregabalin) generic drug versions launch?
Generic name: pregabalin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: October 23, 2026
Generic Entry Controlled by: Spain Patent 2,449,231

This drug has thirty-seven patent family members in thirty-three countries.
See drug price trends for LYRICA CR.
The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-six suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.
When can ORENITRAM (treprostinil diolamine) generic drug versions launch?
Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: April 27, 2026
Generic Entry Controlled by: Spain Patent 2,399,200
ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM
See drug price trends for ORENITRAM.
The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine profile page.
When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?
Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 15, 2026
Generic Entry Controlled by: Spain Patent 2,543,802
VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. 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 VANTRELA ER
The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.
When can APTIOM (eslicarbazepine acetate) generic drug versions launch?
Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: April 21, 2026
Generic Entry Controlled by: Spain Patent 2,371,556

This drug has one hundred patent family members in twenty-six countries. There has been litigation on patents covering APTIOM
See drug price trends for APTIOM.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.
When can APTIOM (eslicarbazepine acetate) generic drug versions launch?
Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: April 21, 2026
Generic Entry Controlled by: Spain Patent 2,562,816

This drug has one hundred patent family members in twenty-six countries. There has been litigation on patents covering APTIOM
See drug price trends for APTIOM.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.
When can BELSOMRA (suvorexant) generic drug versions launch?
Generic name: suvorexant
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 01, 2026
Generic Entry Controlled by: Spain Patent 2,397,188

This drug has seventy-five patent family members in thirty-six countries.
See drug price trends for BELSOMRA.
The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this generic product. Additional details are available on the suvorexant profile page.
When can BOSULIF (bosutinib monohydrate) generic drug versions launch?
Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 28, 2026
Generic Entry Controlled by: Spain Patent 2,449,197
BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.
This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF
See drug price trends for BOSULIF.
The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.
When can OPSUMIT (macitentan) generic drug versions launch?
Generic name: macitentan
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: Spain Patent 2,438,792
OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.
This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSUMIT
See drug price trends for OPSUMIT.
The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.
When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?
Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 23, 2026
Generic Entry Controlled by: Spain Patent 2,704,979

This drug has thirty-two patent family members in twenty-five countries. There has been litigation on patents covering TEKTURNA HCT
See drug price trends for TEKTURNA HCT.
The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
When can TRADJENTA (linagliptin) generic drug versions launch?
Generic name: linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,348,576

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA
See drug price trends for TRADJENTA.
The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.
When can TRADJENTA (linagliptin) generic drug versions launch?
Generic name: linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,527,409

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA
See drug price trends for TRADJENTA.
The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.
When can TRADJENTA (linagliptin) generic drug versions launch?
Generic name: linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,538,818

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA
See drug price trends for TRADJENTA.
The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.
When can KOSELUGO (selumetinib sulfate) generic drug versions launch?
Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 21, 2025
Generic Entry Controlled by: Spain Patent 2,421,746
KOSELUGO is a drug marketed by Astrazeneca. There are eight patents protecting this drug.
This drug has two hundred and one patent family members in forty-five countries. There has been litigation on patents covering KOSELUGO
See drug price trends for KOSELUGO.
The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this generic product. Additional details are available on the selumetinib sulfate profile page.
When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?
Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: January 18, 2026
Generic Entry Controlled by: Spain Patent 2,397,712
CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.
This drug has thirty-nine patent family members in nineteen countries.
The generic ingredient in CAMCEVI KIT is leuprolide mesylate. 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 leuprolide mesylate profile page.
When can KORSUVA (difelikefalin acetate) generic drug versions launch?
Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: Spain Patent 2,394,377
KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.
This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA
See drug price trends for KORSUVA.
The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.
When can ZTALMY (ganaxolone) generic drug versions launch?
Generic name: ganaxolone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 28, 2026
Generic Entry Controlled by: Spain Patent 2,812,250
ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.
This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY
See drug price trends for ZTALMY.
The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.
When can XERMELO (telotristat etiprate) generic drug versions launch?
Generic name: telotristat etiprate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 12, 2026
Generic Entry Controlled by: Spain Patent 2,562,775
XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.
This drug has seventy patent family members in twenty-nine countries.
See drug price trends for XERMELO.
The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.
When can XERMELO (telotristat etiprate) generic drug versions launch?
Generic name: telotristat etiprate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 12, 2026
Generic Entry Controlled by: Spain Patent 2,625,083
XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.
This drug has seventy patent family members in twenty-nine countries.
See drug price trends for XERMELO.
The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.
When can VAFSEO (vadadustat) generic drug versions launch?
Generic name: vadadustat
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 26, 2026
Generic Entry Controlled by: Spain Patent 2,705,587
VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.
This drug has two hundred and fifty-eight patent family members in forty-eight countries. There has been litigation on patents covering VAFSEO
The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat profile page.
When can VAFSEO (vadadustat) generic drug versions launch?
Generic name: vadadustat
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 26, 2026
Generic Entry Controlled by: Spain Patent 2,922,078
VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.
This drug has two hundred and fifty-eight patent family members in forty-eight countries. There has been litigation on patents covering VAFSEO
The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat profile page.
When can OPSYNVI (macitentan; tadalafil) generic drug versions launch?
Generic name: macitentan; tadalafil
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: Spain Patent 2,438,792
OPSYNVI is a drug marketed by Actelion. There are three patents protecting this drug.
This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSYNVI
See drug price trends for OPSYNVI.
The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan; tadalafil profile page.
When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?
Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 22, 2026
Generic Entry Controlled by: Spain Patent 2,348,334
ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.
This drug has twenty-six patent family members in seventeen countries. There has been litigation on patents covering ZUNVEYL
The generic ingredient in ZUNVEYL is benzgalantamine gluconate. One supplier is listed for this generic product. Additional details are available on the benzgalantamine gluconate profile page.
When can VYKAT XR (diazoxide choline) generic drug versions launch?
Generic name: diazoxide choline
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 20, 2026
Generic Entry Controlled by: Spain Patent 2,374,963
VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.
This drug has seventy-eight patent family members in twenty-two countries.
The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline profile page.
When can VYKAT XR (diazoxide choline) generic drug versions launch?
Generic name: diazoxide choline
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 20, 2026
Generic Entry Controlled by: Spain Patent 2,984,297
VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.
This drug has seventy-eight patent family members in twenty-two countries.
The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline profile page.
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