Last Updated: June 13, 2026

Expiring Drug Patents Cheat Sheet
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Israel: These 32 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Israel: These 32 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 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 TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch in Israel?

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. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen 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 in Israel?

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. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen 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 in Israel?

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 seven 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 in Israel?

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 seven 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 in Israel?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Israel Patent 195,294

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 JESDUVROQ (daprodustat) generic drug versions launch in Israel?

Generic name: daprodustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Israel Patent 196,070
Patent Title: תולדות של –{[ 6–הידרוקסי–2,4–דיאוקסו–1, 2, 3, 4 – טטרה–הידרו– 5– פירימידיניל] קרבוניל} גליצין מעכבי פרוליל הידרוקסילאז (Derivatives of n-{[6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl]carbonyl} glycin as prolyl hydroxylase inhibitors)

JESDUVROQ is a drug marketed by Glaxosmithkline. There are six patents protecting this drug.

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

See drug price trends for JESDUVROQ.

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

When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch in Israel?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Israel Patent 195,425

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 BYDUREON (exenatide synthetic) generic drug versions launch in Israel?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882

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

This drug has three hundred and seven 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 in Israel?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180

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

This drug has three hundred and seven 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 in Israel?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181

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

This drug has three hundred and seven 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 in Israel?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182

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

This drug has three hundred and seven 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 in Israel?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882

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

This drug has four hundred and twenty-five 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Israel?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180

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

This drug has four hundred and twenty-five 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Israel?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181

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

This drug has four hundred and twenty-five 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Israel?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182

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

This drug has four hundred and twenty-five 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. Twenty-four 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 in Israel?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 195,882

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

This drug has two hundred and fifty-six 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 in Israel?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,180

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

This drug has two hundred and fifty-six 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 in Israel?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,181

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

This drug has two hundred and fifty-six 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 in Israel?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Israel Patent 214,182

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

This drug has two hundred and fifty-six 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 EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Israel?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Israel Patent 195,488
Patent Title: תרכובות, תכשירים רוקחיים המכילים אותן ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof)

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can RELISTOR (methylnaltrexone bromide) generic drug versions launch in Israel?

Generic name: methylnaltrexone bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Israel Patent 194,182

Drug Price Trends for RELISTOR
RELISTOR is a drug marketed by Salix Pharms and SalixThere are twelve patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has one hundred and twenty-three patent family members in thirty-six countries. There has been litigation on patents covering RELISTOR

See drug price trends for RELISTOR.

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

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Israel?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Israel Patent 196,813
Patent Title: תרכובות ביפניל ביסאימידאזול, תכשירים המכילים אותן ושימושים בהן (Biphenyl bisimidazole compounds, compositions comprising the same and uses thereof)

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can BRILINTA (ticagrelor) generic drug versions launch in Israel?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Israel Patent 196,700

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

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

When can TYMLOS (abaloparatide) generic drug versions launch in Israel?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Israel Patent 197,926
Patent Title: תכשיר יציב המכיל חלבון עצם אנבולי, דהיינו אנלוג ל–pthrp, ושימושיו (Stable composition comprising a bone anabolic protein, namely a pthrp analogue, and uses thereof)

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

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

See drug price trends for TYMLOS.

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

When can KORSUVA (difelikefalin acetate) generic drug versions launch in Israel?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Israel Patent 197,923

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

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

See drug price trends for KORSUVA.

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

When can KORSUVA (difelikefalin acetate) generic drug versions launch in Israel?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Israel Patent 197,924

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

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

See drug price trends for KORSUVA.

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

When can SIRTURO (bedaquiline fumarate) generic drug versions launch in Israel?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Israel Patent 199,077

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

This drug has ninety-seven patent family members in thirty-nine countries.

See drug price trends for SIRTURO.

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

When can ZYKADIA (ceritinib) generic drug versions launch in Israel?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Israel Patent 230,972

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

When can XERMELO (telotristat etiprate) generic drug versions launch in Israel?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Israel Patent 198,806

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

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

See drug price trends for XERMELO.

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

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch in Israel?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Israel Patent 200,108

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

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

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch in Israel?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Israel Patent 200,407

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch in Israel?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Israel Patent 200,407

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch in Israel?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Israel Patent 200,440

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

This drug has one hundred and twenty patent family members in thirty-six countries. There has been litigation on patents covering XENLETA

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can INLYTA (axitinib) generic drug versions launch in Israel?

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Israel Patent 201,320
Patent Title: צורות קריסטל של 6 – [2–מתילקרבמויל) פנילסולפניל] – 3 – e – [2– (פירידינ – 2 –איל) אתניל אינדאזול המתאימות לטיפול בגדילת תאים לא נורמאלית ביונקים (Crystalline forms of 6-[2-(methylcarbamoyl) phenylsulfanyl]-3- e -[2- (pyridin- 2- yl] ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals)

INLYTA is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for INLYTA.

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

When can QVAR REDIHALER (beclomethasone dipropionate) generic drug versions launch in Israel?

Generic name: beclomethasone dipropionate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2027
Generic Entry Controlled by: Israel Patent 201,256

Drug Price Trends for QVAR REDIHALER
QVAR REDIHALER is a drug marketed by Norton Waterford. There are seventeen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has two hundred and seventy-eight patent family members in twenty-seven countries. There has been litigation on patents covering QVAR REDIHALER

See drug price trends for QVAR REDIHALER.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the beclomethasone dipropionate profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Israel?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Israel Patent 201,891
Patent Title: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Israel?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Israel Patent 238,840
Patent Title: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Israel?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Israel Patent 274,602
Patent Title: טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia)

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch in Israel?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Israel Patent 201,571

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

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

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch in Israel?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Israel Patent 202,501
Patent Title: תכשירים המכילים מיקרו חלקיקים לשחרור מבוקר של טריפטולרין ושימוש בהם להכנת תרופה לטיפול בסרטן הערמונית (Pharmaceutical composition made of microparticles for controlled release of triptorelin and use thereof for the manufacture of a drug for the treatment of prostate cancer)

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

See drug price trends for TRELSTAR.

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

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch in Israel?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Israel Patent 202,501
Patent Title: תכשירים המכילים מיקרו חלקיקים לשחרור מבוקר של טריפטולרין ושימוש בהם להכנת תרופה לטיפול בסרטן הערמונית (Pharmaceutical composition made of microparticles for controlled release of triptorelin and use thereof for the manufacture of a drug for the treatment of prostate cancer)

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

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

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch in Israel?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Israel Patent 202,524
Patent Title: מלחים של מדכא ג'אנוס קינאס (r)–3– (4–(7h–פירולו[d–3, 2]פירימידין –4–איל)–h 1–פיראזול–1–איל)–3–ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7 h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile)

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for JAKAFI.

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

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch in Israel?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Israel Patent 264,276
Patent Title: מלחים של מדכא ג'אנוס קינאס (r)– 3– (4–(h7–פירולו[d – 2,3]פירימידין–4–איל)–1h–פיראזול–1l–איל)–3–ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-)

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for JAKAFI.

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

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch in Israel?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Israel Patent 280,401
Patent Title: מלחים של מדכא ג'אנוס קינאס (r)- 3- (4-(h7-פירולו[d – 2,3]פירימידין-4-איל)-1h-פיראזול-1l-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile)

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for JAKAFI.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 18, 2027
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)

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug.

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

See drug price trends for ENTRESTO SPRINKLE.

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

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Israel?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Israel Patent 203,091
Patent Title: נגזרות פירידאזינון (Pyridazinone derivatives)

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

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

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Israel?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Israel Patent 203,094
Patent Title: נגזרות פירימידיניל–פירידאזינון (Pyrimidinyl-pyridazinone derivatives)

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

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

When can KAZANO (alogliptin benzoate; metformin hydrochloride) generic drug versions launch in Israel?

Generic name: alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 19, 2027
Generic Entry Controlled by: Israel Patent 203,171
Patent Title: תכשיר מוצק הכולל אלוגליפטין ומטפורמין הידרוכלוריד (Solid preparation comprising alogliptin and metformin hydrochloride)

Drug Price Trends for KAZANO
KAZANO is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for KAZANO.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

When can INTRAROSA (prasterone) generic drug versions launch in Israel?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Israel Patent 203,747

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

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

See drug price trends for INTRAROSA.

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

Last updated: May 12, 2026

Israel branded and generic drug markets assessment, regulatory opportunities, and patent/IP challenges (2026 outlook)

Israel combines a high-income healthcare payer system with limited domestic manufacturing scale. Branded medicines face price and reimbursement pressure and, increasingly, tighter scrutiny of clinical and economic value. Generics and biosimilars scale quickly once regulatory and exclusivity/IP hurdles clear, but the market is structurally exposed to patent estate strength, Orange Book style listing mechanics, and PI (paragraph IV) litigation dynamics that can delay entry beyond what FDA-style pathways would imply.

The result is a market where (1) IP positioning and launch timing drive value capture, (2) regulatory pathways are navigable but proof burdens are high for certain categories (especially complex generics and line extensions), and (3) payer contracting and tendering can shift commercial outcomes faster than patent challenges alone.


How big is Israel’s branded vs generic drug market, and who captures value after patent expiry?

Featured answer: Israel’s drug spend is dominated by brand and protected products, while unit volume is dominated by generics; value capture after patent expiry depends more on reimbursement contracting and portfolio depth than on entry alone.

Market structure that shapes incentives

  • Branded medicines win when they maintain reimbursement access at favorable contracted prices and defend against substitution and regulatory workarounds.
  • Generics win when they can secure substitution/reimbursement positioning quickly and maintain supply reliability despite small manufacturing footprints.

Commercial entry economics (what matters in practice)

  • Speed to reimbursement often determines whether entry yields near-term revenue or delayed revenue ramp.
  • Tender outcomes and price resets can compress price even after market authorization, making exclusivity and pediatric/line-extension timing critical.
  • Portfolio strategy matters because prescribers and payers respond to formulary coverage and contracting, not just AUC-equivalence.

Biosimilars are a parallel profit pool

  • Biologics in Israel follow a distinct regulatory and access model but converge with generics on the same core question: how fast IP and data exclusivity clear.

What regulatory framework governs generic drug approval in Israel (and how does it compare with EU/US)?

Featured answer: Israel’s generic approvals rely on demonstrating pharmaceutical equivalence and appropriate evidence packages, with increased scrutiny for complex dosage forms, narrow therapeutic index products, and certain switching/substitution claims.

Core authorities and approval logic

  • Regulator: The Ministry of Health (MoH) via its drug regulatory apparatus.
  • Generic authorization logic: Chemical equivalence plus evidence supporting quality, safety, and efficacy, with the evidentiary burden scaled by complexity of the product category.
  • Reference product linkage: Israel’s generic evaluations depend on the identified reference listed in MoH systems and imported/marketed comparators.

EU-style influence, US-style operational issues

  • Israel uses a framework that is more comparable to reference-based European generics than US-style brand listing mechanics.
  • However, Israel’s market access and litigation environment can function similarly to a “no-entry-no-capture” regime when IP protections are actively enforced.

Practical regulatory bottlenecks for generics

  • Complex generics: modified release, combination products, and formulations with clinically relevant device/PK behavior.
  • Narrow therapeutic index: stricter quality and in vivo/in vitro bridging demands.
  • Manufacturing changes: comparability and validation proof needed to sustain approval and supply continuity.

How do patent protections work in Israel for branded drugs, and what patents block generic entry?

Featured answer: Generic entry risk in Israel is primarily driven by how the branded innovator’s patent estate is structured across active ingredient, formulation, use, and manufacturing methods, and whether enforcement is actively pursued against potential infringers.

Patent estate categories that typically block generics

  1. Product (active ingredient) patents
    • Block early “same API” generics until expiry or successful design-around.
  2. Formulation patents
    • Common for sustained release, co-crystals, specific polymorphs, particle size distributions, or excipient systems.
  3. Method-of-use patents
    • Block claims for specific indications, dosing regimens, or patient subpopulations.
  4. Manufacturing process patents
    • Block supply if the generic’s process uses a protected step sequence.

Enforcement and litigation mechanics

  • Israel permits injunction-seeking behavior that can delay entry even when authorization exists.
  • Patent enforcement strategy often targets the specific generic product dossier and planned market launch, not just the generic company.

What is the “Orange Book” equivalent in Israel, and how does it affect market entry timing?

Featured answer: Israel uses public drug and patent-related mechanisms administered through MoH processes rather than a single US-style Orange Book list; the practical effect is still that branded patent listings and enforcement can constrain launch timelines.

What drives discoverability for generic planners

  • Patent relevance mapping against intended generic product and labeling.
  • Regulatory dossier alignment with label carve-outs that avoid method-of-use infringement.
  • Launch sequencing that accounts for injunction risk and potential settlement timelines.

Why this affects planning more than approval

  • MoH authorization does not automatically neutralize infringement risk.
  • Market entry depends on a dual gate: authorization plus freedom-to-operate.

When does exclusivity end for innovative drugs in Israel, and how do pediatric or data exclusivity interact with patents?

Featured answer: Exclusivity and patents are not identical timelines; even after regulatory data protections end, patent estate and enforcement can still delay generic and biosimilar entry.

Timeline drivers

  • Regulatory data exclusivity can delay generic reliance on originator data.
  • Patent expiry sets the “legal” endpoint.
  • Line extensions can extend practical exclusivity via additional patents tied to formulation, new indications, or dosing.

Key timing risk points

  • Substitution and reimbursement contracts may lock in brand share until post-expiry switching thresholds are met.
  • If the originator files additional patents late in the life cycle, generic launch windows can narrow.

What patent litigation affects generic and biosimilar entry in Israel?

Featured answer: Litigation risk concentrates around injunctions, settlement leverage, and claim construction around formulation and method-of-use patents.

Typical litigation patterns seen in small markets

  • Pre-launch injunction targeting: generic prepared but held off by court orders.
  • Settlement to “license and delay” (or carve-out labeling): common where the originator has at least one high-confidence, narrow claim.
  • Design-around disputes: generic tweaks formulation or dosing but faces infringement theories.

Litigation outcomes that change the commercial map

  • A single strong formulation patent can block a whole dosage form.
  • A method-of-use patent can allow generic approval but block labeling, delaying substitution until the brand indication is narrowed or the generic launches an alternate label.

Which companies challenge branded medicines with generics in Israel, and where do they focus?

Featured answer: Generic challengers in Israel typically target high-volume, high-spend therapeutic areas where reimbursement supports rapid substitution and where patent landscapes are navigable through carve-outs.

Common target areas for challenges

  • Cardiometabolic (statins, antihypertensives, diabetes medicines)
  • Oncology supportive and adjunctive therapy
  • Central nervous system agents with strong demand
  • Anti-infectives where supply continuity is commercially valuable

Challenger strategy for small markets

  • Narrow product count, high expected win probability
  • Manufacturing reliability as a competitive advantage
  • Labeling strategies that minimize method-of-use infringement and preserve substitution potential

How strong is the patent estate for top-selling drugs in Israel’s protected segment?

Featured answer: Patent estates are strongest when they combine product + formulation + method-of-use coverage with active enforcement, creating “stacked barriers” for generics and biosimilars.

Strength scoring framework used by market entrants

  • Claim breadth: whether broad composition claims exist or only narrow formulation/processing claims.
  • Multiplicity: number of distinct families covering the same commercial product.
  • Residual term: years remaining across each family.
  • Enforcement history: whether prior challengers settled or exited.
  • Design-around feasibility: whether a “different salt/polymorph/release profile” is plausibly non-infringing.

Portfolio-level implications

  • Even when active ingredient patents expire, formulation and use patents can keep a brand “sticky.”
  • For generics, it can be rational to launch at “launch-of-label” rather than attempt a full substitution if method-of-use coverage remains.

What formulations are protected by patents in Israel, and which dosage forms are most at risk for generic delay?

Featured answer: Sustained release, complex solid oral dosage, and multi-component formulations are the highest risk for formulation-patent blocking in Israel.

Dosage forms most often implicated

  • Modified-release tablets and capsules
  • Transdermal systems
  • Injectable prefilled devices
  • Combination products where each component and their interaction can be claimed

Why formulation patents matter commercially

  • A generic can be approved but blocked from substitution if its formulation falls into an infringement theory.
  • Payer switching often relies on therapeutic equivalence plus labeling similarity; formulation differences can trigger conservative substitution behavior.

What method-of-use patents are most likely to restrict generic labeling in Israel?

Featured answer: Method-of-use patents most often constrain indication-specific labeling, dosing regimens, or patient subgroup claims that are meaningful for real-world prescribing.

How it plays out

  • Generic enters with narrower labeling, reducing interchangeability.
  • Brand maintains share in the protected indication while generics compete in unprotected sub-uses.
  • Over time, if the protected indication narrows (or guidelines shift), generic share rises without needing full patent invalidation.

What generic entry risks exist for complex copies, and when do they become economically rational?

Featured answer: Economic rationality improves only when IP barriers are mapped tightly and reimbursement supports substitution of the specific label/dosage form that is legally safe.

High-risk generic categories

  • Narrow therapeutic index drugs (quality + bridging burdens)
  • Complex modified-release products
  • Products requiring specialized manufacturing steps
  • Multi-API combinations with multiple infringement vectors

Entry timing economics

  • If injunction risk is non-trivial, the generic may wait for either:
    • patent expiry,
    • settlement,
    • or a claim narrowed by court interpretation.

How does Israel’s biosimilar market compare with generics in speed to entry?

Featured answer: Biosimilars typically face heavier evidentiary and IP burdens, but once authorized and cleared, uptake can be rapid where payers adopt switching protocols.

Key biosimilar friction points

  • Product-specific clinical comparability evidence
  • Patent estates often include process and formulation-like quality attributes
  • Method-of-use or device-related claims can affect labeling and interchangeability

Biosimilar commercial path

  • Faster than innovative biologics, but slower than small-molecule generics if IP is actively enforced.
  • Uptake depends on payer policies and hospital formularies.

What are the main regulatory opportunities for investors and BD teams in Israel’s generic market?

Featured answer: Opportunities cluster around complex generic development, line-extension copromotion with branded companies, and manufacturing and tech transfer platforms that reduce regulatory and supply risk.

Opportunity themes with actionable hooks

  • Complex generics where fewer competitors exist and where regulatory dossiers can be differentiated.
  • Portfolio build-outs to achieve payer coverage breadth.
  • Manufacturing localization or contracted reliability to reduce shortage risk and increase tender win probability.
  • Strategic partnerships with local distributors or MoH-facing dossier developers.

Licensing structures that typically fit the market

  • Distribution agreements contingent on regulatory milestones
  • Cross-licensing on method-of-use or formulation carve-outs
  • Supply agreements that align with settlement timing

What regulatory and IP challenges block commercial scale-up in Israel?

Featured answer: The main challenges are (1) stacked patent estates that force label and dosage form carve-outs, (2) injunction risk around pre-launch, and (3) constrained manufacturing supply chains that can undermine tender execution.

Regulatory challenges

  • Evidence scaling for complex generics
  • Labeling constraints linked to method-of-use patents
  • Comparability expectations for manufacturing changes

IP challenges

  • Broad formulation claims that are hard to design around
  • Multiple patent families covering the same commercial product
  • Litigation that targets launch dates, not just eventual damages

Commercial challenges

  • Small market size makes “partial launch” economics less forgiving
  • Contracting and price resets can outpace R&D amortization if launch timing slips

What does the Israel branded vs generic competition landscape look like across major therapeutic areas?

Featured answer: Competition is intense in high-spend chronic therapeutic areas; branded share persists where method-of-use and formulation patents enforce label stickiness.

Competitive dynamics by class (pattern-based)

  • Metabolic disease: generics compete aggressively, but line extensions and dosing optimization patents can preserve brand share.
  • Cardiovascular: fixed-dose combinations and extended-release profiles create formulation/IP leverage.
  • Oncology-supportive: patents tied to specific regimens can block full substitution.
  • CNS: narrow therapeutic index and patient-specific regimens increase formulation and method-of-use risk.

Which commercial deals and settlements matter for market access in Israel’s drug sector?

Featured answer: Settlement agreements that include launch-delay terms, labeling carve-outs, or cross-licenses can determine which products actually reach the market on time.

Settlement deal components that impact launch

  • Date-based launch triggers
  • Territory-specific scope (Israel vs broader jurisdictions)
  • Labeling constraints to avoid infringement
  • Supply permissions and product characteristics permitted

Key risk matrix for branded-to-generic transitions in Israel

Transition stage Main risk Who is exposed Typical mitigation
Patent mapping Wrong claim coverage assumptions Generic entrants Claim-by-claim freedom-to-operate review
Regulatory alignment Label mismatch triggers infringement Generic entrants Label carve-outs + dossier strategy
Pre-launch Injunction risk Both sides Settlement or design-around narrowing
Reimbursement Price reset reduces margin All Portfolio expansion + tender strategy
Post-launch Additional patents (line extensions) Generic entrants Monitor continuing claims and new filings

How to model generic launch scenarios in Israel given patent expiry and litigation risk

Featured answer: A practical launch model uses three gates: regulatory authorization, IP clearance for the specific label/dosage form, and reimbursement contracting readiness.

Scenario set used by market entrants

  • Base case: patent expiry + no injunction, full label entry within expected authorization-to-market window.
  • Downside: injunction or partial labeling carve-out delays substitution; revenue ramps slower and price compression is higher.
  • Upside: early settlement allows launch aligned with reimbursement renewal cycles.

What drives outcome variance

  • Strength of the last remaining formulation or method-of-use claims
  • Speed of court handling for injunctions
  • Whether the payer’s substitution policy is permissive for the protected indication

Which regulatory opportunities are highest-return for branded companies defending share in Israel?

Featured answer: Brand companies can defend via line extensions that create patent-protected differentiation while maintaining reimbursement access through clinical and economic contracting narratives.

Defensive levers

  • Develop and register line extensions aligned with enforceable patents
  • Use indication-specific evidence to strengthen method-of-use positions
  • Prepare for generic substitution behavior with real-world data packages

Key Takeaways

  • Israel’s market rewards fast, legally clean entry: authorization is necessary but not sufficient when formulation and method-of-use patents are actively enforced.
  • Patent estates frequently stack product, formulation, and method-of-use claims, forcing generic label and dosage form carve-outs.
  • Regulatory pathways are navigable, but complex generics carry higher evidence and bridging burdens that increase both cost and timeline risk.
  • Biosimilars follow a similar IP-driven pattern with heavier comparability and quality attribute expectations.
  • Commercial outcomes hinge on reimbursement contracting and tender cycles, so launch timing and portfolio breadth are as important as IP position.

FAQs

1) What categories of generics face the highest regulatory evidence burden in Israel?

Complex modified-release, narrow therapeutic index products, injectables, and multi-component combinations.

2) Do method-of-use patents block MoH authorization in Israel or only delay market entry?

They most often constrain labeling and interchangeability, creating practical entry and substitution delays even when authorization is possible.

3) Are injunctions a major driver of generic delay in Israel?

Yes, injunction risk concentrated around planned launch dates can materially shift effective entry timing.

4) How should generic companies plan around line extensions in Israel?

Map continuing and later-filed patent families against the exact formulation and labeling intended for the Israeli market.

5) What tends to speed generic adoption after patent expiry in Israel?

Reimbursement contracting that supports substitution for the specific label/dosage form, plus uninterrupted supply and competitive tender outcomes.


References

  1. Israel Ministry of Health. Drug registration and regulatory guidance (official MoH publications).
  2. World Health Organization. Regulatory assessment and post-approval considerations for generic and biosimilar medicines.
  3. European Medicines Agency (EMA). Guideline on the investigation of bioequivalence and comparability principles for generics and biosimilars.
  4. OECD. Competition and pricing dynamics in pharmaceutical markets and incentives for generics.

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