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Last Updated: April 20, 2025

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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Spain: These 39 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Spain: These 39 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 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 XCOPRI (cenobamate) generic drug versions launch?

Generic name: cenobamate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 22, 2025
Generic Entry Controlled by: Spain Patent 2,441,765

Drug Price Trends for XCOPRI
XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug.

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

See drug price trends for XCOPRI.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Spain Patent 2,380,887

BELEODAQ is a drug marketed by Acrotech Biopharma. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in twenty-seven countries. There has been litigation on patents covering BELEODAQ

See drug price trends for BELEODAQ.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Spain Patent 2,540,204

BELEODAQ is a drug marketed by Acrotech Biopharma. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in twenty-seven countries. There has been litigation on patents covering BELEODAQ

See drug price trends for BELEODAQ.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Spain Patent 2,378,778

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety-one patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Spain Patent 2,535,179

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety-one patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can TRACLEER (bosentan) generic drug versions launch?

Generic name: bosentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 17, 2025
Generic Entry Controlled by: Spain Patent 2,336,943

TRACLEER is a drug marketed by Actelion. There are two patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has twenty-eight patent family members in twenty-three countries. There has been litigation on patents covering TRACLEER

See drug price trends for TRACLEER.

The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the bosentan profile page.

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Spain Patent 2,408,687

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

This drug has fifty-eight patent family members in twenty-three countries. There has been litigation on patents covering LATUDA

See drug price trends for LATUDA.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this API. Thirty suppliers are listed for this generic product. Additional details are available on the lurasidone hydrochloride profile page.

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Spain Patent 2,535,478

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

This drug has fifty-eight patent family members in twenty-three countries. There has been litigation on patents covering LATUDA

See drug price trends for LATUDA.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this API. Thirty suppliers are listed for this generic product. Additional details are available on the lurasidone hydrochloride profile page.

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2025
Generic Entry Controlled by: Spain Patent 2,572,980

VICTRELIS is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

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

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

When can SPINRAZA (nusinersen sodium) generic drug versions launch?

Generic name: nusinersen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2025
Generic Entry Controlled by: Spain Patent 2,397,113

SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.

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

See drug price trends for SPINRAZA.

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

When can SPINRAZA (nusinersen sodium) generic drug versions launch?

Generic name: nusinersen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2025
Generic Entry Controlled by: Spain Patent 2,545,223

SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.

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

See drug price trends for SPINRAZA.

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

When can SPINRAZA (nusinersen sodium) generic drug versions launch?

Generic name: nusinersen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2025
Generic Entry Controlled by: Spain Patent 2,702,531

SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.

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

See drug price trends for SPINRAZA.

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

When can BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
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.

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 DUEXIS (famotidine; ibuprofen) generic drug versions launch?

Generic name: famotidine; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 18, 2025
Generic Entry Controlled by: Spain Patent 2,380,747

Drug Price Trends for DUEXIS
DUEXIS is a drug marketed by Horizon. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries. There has been litigation on patents covering DUEXIS

See drug price trends for DUEXIS.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Spain Patent 2,371,556

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. 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 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. Two 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 Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Spain Patent 2,562,816

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. 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 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. Two suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Spain Patent 2,360,473

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Spain Patent 2,555,230

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2025
Generic Entry Controlled by: Spain Patent 2,320,174

CREON is a drug marketed by

This drug has one hundred and forty patent family members in forty-three countries. There has been litigation on patents covering CREON

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 CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2025
Generic Entry Controlled by: Spain Patent 2,341,284

CREON is a drug marketed by

This drug has one hundred and forty patent family members in forty-three countries. There has been litigation on patents covering CREON

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 JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,358,217

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,379,153

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,527,794

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,358,217

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,379,153

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Spain Patent 2,527,794

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: Spain Patent 2,496,144

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-four patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-three suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
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 forty-one patent family members in nineteen countries.

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 VARITHENA (polidocanol) generic drug versions launch?

Generic name: polidocanol
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 21, 2025
Generic Entry Controlled by: Spain Patent 2,366,399

VARITHENA is a drug marketed by Provensis. There are two patents protecting this drug.

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

See drug price trends for VARITHENA.

The generic ingredient in VARITHENA is polidocanol. Two suppliers are listed for this generic product. Additional details are available on the polidocanol profile page.

When can LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Spain Patent 2,449,231

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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-five suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Spain Patent 2,449,765

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in forty countries. There has been litigation on patents covering ENTRESTO SPRINKLE

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Spain Patent 2,823,749

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

This drug has one hundred and twenty-eight patent family members in forty countries. There has been litigation on patents covering ENTRESTO SPRINKLE

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: Spain Patent 2,812,250

ZTALMY is a drug marketed by Marinus. There are nine patents protecting this drug.

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

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 AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
Generic Entry Controlled by: Spain Patent 2,663,496

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries.

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this generic product. Additional details are available on the fluciclovine f-18 profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2025
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 PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Spain Patent 2,461,315

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

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 KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Spain Patent 2,421,746

KOSELUGO is a drug marketed by Astrazeneca. There are six patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

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 Key Patent Expiration / Generic Entry 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 AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Spain Patent 2,392,590

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries. There has been litigation on patents covering AMITIZA

See drug price trends for AMITIZA.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this API. Nineteen suppliers are listed for this generic product. Additional details are available on the lubiprostone profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: Spain Patent 2,593,028

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Sixteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can MACRILEN (macimorelin acetate) generic drug versions launch?

Generic name: macimorelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 18, 2026
Generic Entry Controlled by: Spain Patent 2,404,582

MACRILEN is a drug marketed by Novo. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

See drug price trends for MACRILEN.

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

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Spain Patent 2,581,982

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Spain Patent 2,378,573

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the amphetamine profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Spain Patent 2,396,039

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the amphetamine profile page.

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Spain Patent 2,378,573

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Spain Patent 2,396,039

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Spain Patent 2,378,785

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

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

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this generic product. Additional details are available on the florbetapir f-18 profile page.

When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Spain Patent 2,628,882

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

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

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this generic product. Additional details are available on the florbetapir f-18 profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Spain Patent 2,594,655

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

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 LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Spain Patent 2,752,823

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

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 ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: Spain Patent 2,377,387

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 ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,348,576

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

This drug has four hundred and sixty-two 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 Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,527,409

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

This drug has four hundred and sixty-two 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 Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Spain Patent 2,538,818

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

This drug has four hundred and sixty-two 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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Spain Patent 2,452,033

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.

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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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.

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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Spain Patent 2,611,794

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.

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 TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Spain Patent 2,355,434

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and sixteen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Spain Patent 2,379,200

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and sixteen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Spain Patent 2,432,102

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and sixteen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,385,612

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 EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry 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 EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,622,576

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 EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,636,657

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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,527,437

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

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

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Spain Patent 2,602,069

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

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

Market Analysis and Financial Projection

Spain's pharmaceutical market presents a dynamic interplay between branded and generic drug sectors, shaped by regulatory reforms, cost-containment pressures, and evolving market access strategies. Below is a detailed assessment:

Branded Drug Market Dynamics

  • Dominance in Logistics: Branded drugs command 79% of Spain's pharmaceutical logistics market due to physician trust and complex therapeutic applications (e.g., oncology, immunology) [9].
  • Innovation Challenges: Slow reimbursement processes delay market entry for innovative therapies, with average Therapeutic Positioning Report (IPT) approvals taking 297–780 days versus the 93-day target [4]. Only 23% of EU-approved orphan drugs receive full reimbursement in Spain [4].
  • Price Transparency Risks: Public disclosure of confidential net prices may lead to international reference pricing (IRP) disputes, potentially discouraging manufacturers from launching premium-priced therapies [2].

Generic Drug Market Growth

  • Projected Expansion: The generic drug market is expected to grow at 6.69% CAGR (2023–2029), reaching $21.52B, driven by:
    • Patent Cliffs: Biosimilars like adalimumab and trastuzumab reduced treatment costs by 50% post-patent expiration [7][8].
    • Cost-Efficiency: Generics are priced 16% below the EU average, accounting for 40% of dispensed units but only 21% of total drug spending [3][14].
  • Key Players: Laboratorios Normon, Teva Pharma, and Viatris lead production across cardiovascular, diabetes, and oncology therapies [1][7].

Regulatory Opportunities

  1. HTA Reforms: Spain’s 2023 regulatory plan adopts UK NICE-style health technology assessments to accelerate evaluations, requiring pharmacoeconomic studies from manufacturers [4].
  2. Early Access Schemes: Proposed reforms aim to fast-track drugs with high clinical potential, addressing delays in rare disease therapies [4].
  3. EU Harmonization: Amendments to RDL 1/2015 align Spanish law with EU standards for biologics, medical devices, and personalized medicine [4][5].

Key Challenges

  • Price Erosion: Reference pricing policies and mandatory generics substitution reduce profitability for branded drugs, while generics face margin pressures from regional tenders (e.g., Andalusia’s 2024 tender challenged in court for violating national pricing laws) [12][14].
  • Supply Chain Risks: Centralized purchasing and clawback mechanisms threaten supply continuity for low-margin generics, particularly in niche therapeutic areas [15][16].
  • Competition: Intense price wars between domestic and multinational generic manufacturers (e.g., Sun Pharma vs. STADA) strain R&D investments [8].

Regional Insights:
The Central Region of North Spain accounts for 44% of the generics market, supported by advanced manufacturing hubs in Madrid and Barcelona [8]. However, regional disparities in reimbursement policies create fragmentation, with Catalonia offering faster access to biosimilars than Andalusia [12].

“If the trend of making hidden net prices visible continues, manufacturers may hesitate to offer concessions, impacting Spain’s NHS sustainability.” – Simon-Kucher & Partners [2]

Strategic Recommendations

  • For Branded Drugs: Leverage early access pathways and partner with AEMPS to streamline IPT processes.
  • For Generics: Invest in biosimilar R&D and engage AESEG (Spanish Generic Association) to advocate against predatory tenders.
  • Regulatory Compliance: Use Freyr Solutions or similar consultancies to navigate AEMPS submissions, particularly for hybrid applications under Article 10(3) [5][10].

Spain’s balancing act between innovation incentives and cost containment will define its pharmaceutical trajectory through 2030. Success hinges on aligning EU regulatory frameworks with localized access policies while mitigating IRP-related risks.

References

  1. https://www.biospace.com/spain-pharmaceutical-market-to-reach-a-cagr-of-5-40-during-2024-2032-impelled-by-increasing-adoption-of-generic-drugs
  2. https://www.simon-kucher.com/en/insights/drug-price-transparency-spain-are-pharma-innovations-spanish-market-risk
  3. https://www.researchandmarkets.com/reports/5650969/spain-generics-market-summary-competitive
  4. https://www.pharmtech.com/view/changes-afoot-in-pharmaceutical-laws-and-regulations-in-spain
  5. https://www.freyrsolutions.com/medicinal-products/pharma-regulatory-services-in-spain
  6. https://pharmexcil.com/uploads/countryreports/Spain_Market_Regulatory_report2020.pdf
  7. https://www.globenewswire.com/news-release/2025/01/23/3014473/0/en/Spain-Generic-Drugs-Market-Research-2024-Competitive-Landscape-Forecast-Opportunities-2019-2029-Patent-Expirations-Biologic-and-Biosimilar-Generics-Specialty-Generics.html
  8. https://www.techsciresearch.com/report/spain-generic-drugs-market/22117.html
  9. https://www.mordorintelligence.com/industry-reports/spain-pharmaceutical-logistics-market
  10. https://www.freyrsolutions.com/global/regulatory-services-in-spain
  11. https://www.elsevier.es/es-revista-atencion-primaria-27-articulo-commentary-problems-with-increasing-use-13038749
  12. http://www.aeseg.es/es/entrevistas-aeseg/1828-spanish-generic-industry-takes-lead-in-court-challenges-to-andalusias-drug-tender
  13. https://www.globallegalinsights.com/practice-areas/pricing-reimbursement-laws-and-regulations/spain/
  14. https://www.trade.gov/market-intelligence/spain-pharmaceutical-sector
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC6340485/
  16. https://gabionline.net/country-focus/spain

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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.