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Last Updated: June 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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Israel: These 31 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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

Preferred citation:
Friedman, Yali, "Israel: These 31 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 APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Israel Patent 185,760
Patent Title: הרכבים של מלח בופרופיון בעלי שחרור מותאמים (Modified-release formulations of a bupropion salt)

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide 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: Israel Patent 188,732
Patent Title: שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments)

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. Thirteen suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen 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: Israel Patent 196,425
Patent Title: יחידת מינון למתן פומי המכילה איבופרופן ופאמוטידין (Oral unit dose form containing ibuprofen and famotidine)

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. Thirteen suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen 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: Israel Patent 188,227
Patent Title: תרכובות מקרוציקליות, שילובים ותכשירים רוקחיים המכילים אותן, שימושים בהן כמעכבי וירוס הפטיטיס c ותהליכים להכנתן (Macrocyclic compounds, combinations and pharmaceutical compositions comprising them, uses thereof as inhibitors of hepatitis c virus and processes for their preparation)

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 EPSOLAY (benzoyl peroxide) generic drug versions launch?

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 02, 2025
Generic Entry Controlled by: Israel Patent 189,159
Patent Title: חיפוי של מתכת אוקסיד למרכיבים בלתי מסיסים במים (Metal oxide coating of water insoluble ingredients)

Drug Price Trends for EPSOLAY
EPSOLAY is a drug marketed by Galderma Labs Lp. There are twelve patents protecting this drug. One tentatively approved generic is ready to enter the market.

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

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the benzoyl peroxide 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: Israel Patent 189,456
Patent Title: תהליך להכנת הרכב פרמצבטי לשחרור נשלט הכולל פנקראטין (Process for producing a controlled release pharmaceutical composition comprising pancreatin)

CREON is a drug marketed by

This drug has fifty-one patent family members in fifteen 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. One supplier is listed for this generic product. 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: Israel Patent 189,457
Patent Title: תהליך שחול לייצור ליבות מיקרו כדוריות סנתטיות ללא שמן הכוללות פנקריאטין ופוליאתילן גליקול 4000 (Extrusion process for the manufacture of synthetic oil- free micropellet cores comprising pancreatin and polyethylene glycol 4000)

CREON is a drug marketed by

This drug has fifty-one patent family members in fifteen 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. One supplier is listed for this generic product. 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: Israel Patent 189,481
Patent Title: תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process)

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. Seven 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: Israel Patent 217,444
Patent Title: תהליך עבור תרכובות בנזאפין או מלחים מזה (Process for preparing benzazepine compounds or salts thereof)

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. Seven 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: Israel Patent 217,445
Patent Title: תהליך עבור ייצור תרכובת חומצה בנזאוית (Process for producing a benzoic acid compound)

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. Seven 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: Israel Patent 217,446
Patent Title: תכשיר רוקחי המכיל מרכיב פעיל מטוהר מאוד של 7- כלורו - 5 - הידרוקסי- 1- [2-מתיל-4-(2-מתילבנזואיל-אמינו)בנזואיל]-2, 3, 4, 5 - טטראהידרו- h 1 - 1 - בנזאזפין בעל טוהר של יותר מ - 99.5% או מלח שלו, או תכשיר רוקחות של מלח שלו (Pharmaceutical composition comprising as an active ingredient a highly pure 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methyl¬benzoyl¬amino)benzoyl]-2,3,4,5-tetrahydro-1h-1-benzazepine having a purity of more than 99.5 %, or a salt thereof, or a pharmaceutically acceptable salt thereof)

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. Seven 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: Israel Patent 222,396
Patent Title: תהליך הכנה תרכובת ל 4-(בנזואילאמינו) חומצה בנזואיק או מלחים שלהם (Process for preparing 4-(benzoylamino)benzoic acid compounds or salts thereof)

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. Seven 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: Israel Patent 189,481
Patent Title: תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process)

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. Seven 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: Israel Patent 217,444
Patent Title: תהליך עבור תרכובות בנזאפין או מלחים מזה (Process for preparing benzazepine compounds or salts thereof)

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. Seven 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: Israel Patent 217,445
Patent Title: תהליך עבור ייצור תרכובת חומצה בנזאוית (Process for producing a benzoic acid compound)

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. Seven 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: Israel Patent 217,446
Patent Title: תכשיר רוקחי המכיל מרכיב פעיל מטוהר מאוד של 7- כלורו - 5 - הידרוקסי- 1- [2-מתיל-4-(2-מתילבנזואיל-אמינו)בנזואיל]-2, 3, 4, 5 - טטראהידרו- h 1 - 1 - בנזאזפין בעל טוהר של יותר מ - 99.5% או מלח שלו, או תכשיר רוקחות של מלח שלו (Pharmaceutical composition comprising as an active ingredient a highly pure 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methyl¬benzoyl¬amino)benzoyl]-2,3,4,5-tetrahydro-1h-1-benzazepine having a purity of more than 99.5 %, or a salt thereof, or a pharmaceutically acceptable salt thereof)

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. Seven 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: Israel Patent 222,396
Patent Title: תהליך הכנה תרכובת ל 4-(בנזואילאמינו) חומצה בנזואיק או מלחים שלהם (Process for preparing 4-(benzoylamino)benzoic acid compounds or salts thereof)

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. Seven 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: Israel Patent 189,273
Patent Title: תצורה קפסולרית של פירפנידון וחומרי תרופה בלתי-פעילים המתאימים מבחינה פרמצבטית (Capsule formulation of pirfenidone and pharmaceutically acceptable excipients)

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-five 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-four suppliers are listed for this generic product. Additional details are available on the pirfenidone 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: Israel Patent 190,827
Patent Title: PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT

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-three 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: Israel Patent 184,027
Patent Title: תרכובת טריסודיום [3-((1s, 3r)-1-ביפניל-4-ילמתיל-3-אתוקסיקרבוניל-1-בוטילקרבמויל)פרופיונאט-(s)-'3-מתיל-'2-(פנטהנויל{" 2-(טטרזול-5-ילאט)ביפניל-'4-ילמתיל}אמינו)בוטיראט] המיפנטההידראט, תכשירים רוקחיים שלה, שיטה להכנתה ושימוש בה להכנת תרופות (Compound trisodium [3-((1s,3r)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(s)-3’-methyl-2’-(pentanoyl{2’’-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate] hemipentahydrate, its pharmaceutical compositions, method for its preparation and use thereof in the preparation of medicaments)

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. Seven 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: Israel Patent 191,759
Patent Title: תכשירי גנקסולון ושיטות להכנתם ושימוש בהם (Ganaxolone formulations and methods for the making and use thereof)

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: Israel Patent 191,184
Patent Title: ציקלובוטיל מותמר כתרכובת אב לתרכובות אורגנית המתויגת עם הלוגן רדיואקטיבי (Substituted cyclobutyl precursor compound for radioactive halogen-labeled organic compounds)

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 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: Israel Patent 235,029
Patent Title: שיטה לייצור 1-אמינו-3-[18f]פלואורוציקלובוטאן חומצה קרבוקסילית מתרכובת אב מסומנת (Method for the production of 1-amino-3-[18f]fluorocyclobutanecarboxylic acid from a labeled precursor compound)

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: Israel Patent 191,971
Patent Title: פולימורפים של מעכב hgfr/met-c (Polymorphs of a c-met/hgfr inhibitor)

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: Israel Patent 192,221
Patent Title: תכשירים רפואיים המכילים angelate- 3- ingenol (Therapeutic compositions comprising ingenol-3-angelate)

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: Israel Patent 192,224
Patent Title: מלח מימן גופרתי של 6-(4-ברומו-2-כלורו-פנילאמינו)-7-פלואורו-3-מתיל-h3-בנזואימידאזול-5-חומצה קרבוקסילית (2-הידרוקסי-אתוקסי)-אמיד לטיפול במחלות המטופלות ע''י עכבה של mek (Hydrogen sulfate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3h-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide for treating diseases treated by inhibition of mek)

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 AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Israel Patent 192,867
Patent Title: הרכב קפסולת ג'לטין רך (Soft-gelatin capsule formulation)

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. Twenty 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: Israel Patent 193,153
Patent Title: תהליך להכנת אגוניסט לקולטן אדנוזין a2a (Process for preparing an a2a-adenosine receptor agonist)

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 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: Israel Patent 194,042
Patent Title: פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)

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: Israel Patent 194,042
Patent Title: פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)

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: Israel Patent 193,567
Patent Title: סטרילפירידין ותולדות סטרילפירידין מסומנות רדיואקטיבית, תכשירים המכילים אותם, תכשירים דיאגנוסטיים והשימוש בהם (Styrylpyridine and radiolabeled styrylpyridine derivatives, compositions comprising them, diagnostic compositions and uses thereof)

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: Israel Patent 194,473
Patent Title: טיפולים לאלרגיה בעיניים (Ocular allergy treatments)

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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Israel Patent 195,030
Patent Title: הרכבים של מעכב iv dpp (Dpp iv inhibitor formulations)

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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Israel Patent 195,015
Patent Title: צורה גבישית חסרת מים של מלח לקטט של n-הידרוקסי-3-[4-[[[2-(2-מתיל-h1-אינדול-3-יל)אתיל]אמינו]מתיל]פניל]-e2-2-פרופנאמיד (Substantially pure crystalline anhydrous form of the lactate salt of n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide)

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries. There has been litigation on patents covering FARYDAK

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate 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: Israel Patent 195,511
Patent Title: 1- [2-(2, 4-דימתילפנילסולפניל)-פניל]פיפרזין כתרכובת גבישית ושימושו להכנת תרופה לטיפול בליקוי קוגניטיבי (1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine which compound is crystalline and use thereof for the preparation of a medicament for treatment of cognitive impairment)

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: Israel Patent 200,956
Patent Title: 1-[2-(2,4-דימתילפנילסולפניל)-פניל]פיפרזין לטיפול בכאב (1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine for use in the treatment of pain)

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: Israel Patent 195,834
Patent Title: הרכב המכיל ריבוי כדוריות רב שכבתיות ושימושו (Compositions comprising a plurality of multi-layer pellets and use thereof)

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: Israel Patent 235,150
Patent Title: תכשירי רוקחות (Pharmaceutical compositions)

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: Israel Patent 195,294
Patent Title: תהליך לייצור ספינאמיד או רלפינאמיד ברמת טהור גבוהה, שימושם בהכנת תרופות ותכשירים רפואיים המכילים אותם (Process for producing high purity safinamide or ralfinamide, use thereof in the preparation of medicaments and pharmaceutical formulations containing them)

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 TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Israel Patent 195,425
Patent Title: תכשירים גלניקלים של אליסקירן והידרוכלורותיאזיד (Galenical formulations of aliskiren and hydrochlorothiazide)

Drug Price Trends for TEKTURNA HCT
TEKTURNA HCT is a drug marketed by Noden Pharma. There is one patent protecting this drug and one Paragraph IV challenge.

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 VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Israel Patent 196,127
Patent Title: מעכבי פרוליל הידרוקסילאז, מלחים שלהם המקובלים ברוקחות, תכשירי רוקחות המכילים אותם, ושימושים שלהם לטיפול במגוון מחלות (Prolyl hydroxylase inhibitors, pharmaceutically acceptable salts thereof, pharmaceutical compositions containing them and uses thereof for the treatment of a variety of diseases)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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 BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882
Patent Title: צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

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 BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות של (s1) -1, 5 אנהידרו- 1 - c - ( 3- ((פניל(מתיל(פניל)-d- גלוציטול עם חומצות אמינו המשמשים כמעכבי sglt2 עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

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 BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

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 BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות 1s))-5,1-אנהידרו-1-c-(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

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 FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882
Patent Title: צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות של (s1) -1, 5 אנהידרו- 1 - c - ( 3- ((פניל(מתיל(פניל)-d- גלוציטול עם חומצות אמינו המשמשים כמעכבי sglt2 עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות 1s))-5,1-אנהידרו-1-c-(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are eighteen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882
Patent Title: צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes)

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות של (s1) -1, 5 אנהידרו- 1 - c - ( 3- ((פניל(מתיל(פניל)-d- גלוציטול עם חומצות אמינו המשמשים כמעכבי sglt2 עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182
Patent Title: סולבטים גבישיים וקומפלקסים של נגזרות 1s))-5,1-אנהידרו-1-c-(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

rael's Pharmaceutical Market: Branded vs. Generic Drugs and Regulatory Landscape

Israel’s pharmaceutical sector combines cutting-edge innovation with robust generic drug production, supported by a regulatory framework focused on cost containment and accessibility. With a market size of $336 million (2023) and projected growth at a 5.85% CAGR[8], the country balances patented drug development with one of the world’s most active generic markets led by Teva Pharmaceutical Industries[13]. Below, we explore the dynamics of branded and generic drug markets and analyze regulatory opportunities and challenges.


Market Overview

Branded Drugs: Innovation and Key Players

Israel’s branded drug market is driven by R&D investments in oncology, neurology, and biotechnology. Teva Pharmaceutical, the largest player, focuses on CNS disorders and biologics[13], while companies like Maccabi Healthcare leverage telemedicine and clinical trials to enhance drug accessibility[5]. The market’s growth (3.9% CAGR from 2015–2020)[5] is supported by:

  • Blockbuster drugs: Including treatments for multiple sclerosis and cancer[5].
  • Technological integration: National health information systems[5] and AI-driven drug docking[1].

Generic Drugs: Affordability and Dominance

Generic drugs account for 15–20% of pharmaceutical sales, saving ~$500 million annually[5]. Key drivers include:

  • Cost savings: 20–80% cheaper than branded equivalents[1].
  • Government policies: Mandatory substitution and INN prescriptions[1][4].
  • Regional segmentation: Mediterranean Coastal Plain leads due to infrastructure and manufacturing hubs[6].
Top Companies Company Market Cap (2023) Focus Area
Teva Pharmaceutical $25.1B CNS, generics[13]
Taro Pharmaceutical $914M APIs, generics[13]
Dexcel Pharma - Topical/oral generics[1]

Regulatory Opportunities

1. Streamlined Approvals

  • Abridged pathways: 52.7% of drug applications (2014–2016) relied on FDA/EMA approvals for faster authorization[7].
  • OTC expansion: Recent reforms allow non-pharmacy sales of painkillers, antidiarrheals, and topical treatments[11].

2. Cost Containment Policies

  • Price controls: The Ministry of Health caps drug prices and mandates generics for off-patent drugs[12].
  • Incentives for local production: Tax benefits for domestic generic manufacturers[1].

3. Technology Adoption

AI and nanotechnology are prioritized for drug development, enhancing bioavailability and reducing time-to-market[1][6].

“Government has succeeded in containing drug costs whilst maintaining a basket of reimbursable drugs that is comprehensive and technologically advanced.”[4]


Regulatory Challenges

1. Drug Shortages

Between 2013–2015, shortages arose from:

  • Supply chain fragility: Overreliance on single suppliers[3].
  • Price caps: Costs below ₪17 ($4.5) led to discontinued production[3].

2. Intellectual Property Tensions

  • Data exclusivity: Generic firms can access branded drug data pre-patent expiry, risking innovation disincentives[14].
  • Patent linkage debates: A 2023 ministerial review seeks to align Israel with U.S./EU IP standards[14].

3. Compliance Complexity

  • GMP requirements: Local manufacturers must adhere to EU standards, with phased QP certification for clinical trials[10].
  • Post-approval variations: 17% of drugs face additional restrictions after FDA/EMA approval[7].

Key Takeaways

  1. Generics dominate: Cost policies and tech advancements drive 20–80% price advantages.
  2. Regulatory agility: Fast-track approvals and OTC reforms boost accessibility but require stricter IP safeguards.
  3. Innovation focus: AI and biotechnology position Israel as a global R&D hub.

FAQs

1. How does Israel’s generic drug market compare globally?
Israel ranks 15th in pharmaceutical exports, with generics contributing $500M+ annual savings[5][8].

2. What role does Teva Pharmaceutical play?
Teva holds 75% of Israel’s generic market share and leads in global CNS drug innovation[13].

3. Are branded drugs accessible under NHI?
Yes, but approval requires proof of cost-effectiveness and therapeutic superiority[4].

4. How are drug shortages addressed?
The MoH mandates 1-month stockpiles and expedited grandfather drug approvals[3].

5. What recent regulatory changes affect OTC drugs?
Liquid paracetamol (60ml) and ibuprofen (higher doses) can now be sold in supermarkets[11].

Sources: [1][3][4][5][8][11][13][14]

References

  1. https://www.techsciresearch.com/report/israel-generic-drugs-market/15460.html
  2. https://www.grandviewresearch.com/horizon/outlook/active-pharmaceutical-ingredients-market/israel
  3. https://pubmed.ncbi.nlm.nih.gov/28392910/
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC4049385/
  5. https://www.pharmaceutical-technology.com/research-reports/researchreportreport-israeli-pharmaceutical-market-to-grow-at-a-compound-annual-growth-rate-of-39-5685762/
  6. https://www.techsciresearch.com/news/9688-israel-generic-drugs-market.html
  7. https://bmjopen.bmj.com/content/bmjopen/13/5/e067313.full.pdf
  8. https://www.reportlinker.com/dataset/b42b78f5f20fd93f82dc214f87ab20bb5c2eee50
  9. https://www.clinicalleader.com/doc/israel-s-emergence-as-a-go-to-market-for-conducting-clinical-trials-0001
  10. https://imp-services.co.il/navigating-regulatory-differences-the-role-of-qualified-persons-in-israel-and-the-eu/
  11. https://www.jpost.com/health-and-wellness/article-810411
  12. https://www.pharma-israel.org.il/en/activities/regulations/
  13. https://www.globaldata.com/companies/top-companies-by-sector/healthcare/israel-companies-by-market-cap/
  14. https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=106597388
  15. https://www.freyrsolutions.com/global/regulatory-services-in-israel
Last updated: 2025-03-19

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