Innovator Drugs Facing Paragraph IV Filings
Drugs approaching patent expiration that have been challenged through Paragraph IV filings with limited generic competition
1. Auryxia patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US8093423 | KERYX BIOPHARMS | Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same |
Apr, 2026
(a month from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-790) | Nov 06, 2020 |
Drugs and Companies using FERRIC CITRATE ingredient
Market Authorisation Date: 05 September, 2014
Treatment: Control of serum phosphorous levels
Dosage: TABLET
How can I launch a generic of AURYXIA before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of AURYXIA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the AURYXIA's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on AURYXIA:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 30 Mar, 2015 | 21 Apr, 2026 | Non-Forfeiture | Less |
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AURYXIA family patents
2. Bosulif patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7767678 | PF PRISM CV | Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same |
Nov, 2026
(8 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 04, 2017 |
| Orphan Drug Exclusivity(ODE) | Sep 04, 2019 |
| Orphan Drug Exclusivity(ODE-30) | Sep 04, 2019 |
| New Indication(I-759) | Dec 19, 2020 |
| Orphan Drug Exclusivity(ODE-163) | Dec 19, 2024 |
| New Indication(I-923) | Sep 26, 2026 |
| New Product(NP) | Sep 26, 2026 |
| Pediatric Exclusivity(PED) | Mar 26, 2027 |
| Orphan Drug Exclusivity(ODE-444) | Sep 26, 2030 |
Drugs and Companies using BOSUTINIB MONOHYDRATE ingredient
NCE-1 date: 04 September, 2016
Market Authorisation Date: 04 September, 2012
Treatment: NA
Dosage: TABLET
How can I launch a generic of BOSULIF before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of BOSULIF's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the BOSULIF's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on BOSULIF:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 25 Oct, 2018 | 23 Nov, 2026 | Less | |||
| 06 Sep, 2016 | 23 Nov, 2026 | Deferred | 23 May, 2025 | Less |
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BOSULIF family patents
3. Dymista patent
expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
|
US8168620 (Pediatric) | MYLAN | Combination of azelastine and steroids |
Aug, 2026
(5 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | May 01, 2015 |
| New Patient Population(NPP) | Feb 20, 2018 |
| Pediatric Exclusivity(PED) | Aug 20, 2018 |
Drugs and Companies using AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE ingredient
Market Authorisation Date: 01 May, 2012
Treatment: NA
Dosage: SPRAY, METERED
How can I launch a generic of DYMISTA before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of DYMISTA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the DYMISTA's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on DYMISTA:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Jun, 2014 | 24 Aug, 2026 | Eligible | 28 Apr, 2017 | Less |
More Information on Dosage
DYMISTA family patents
4. Fycompa patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US8772497 | CATALYST | Method for producing 1, 2-dihydropyridine-2-one compound |
Jul, 2026
(4 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 22, 2017 |
| New Indication(I-710) | Jun 19, 2018 |
Drugs and Companies using PERAMPANEL ingredient
NCE-1 date: 22 October, 2016
Market Authorisation Date: 22 October, 2012
Treatment: NA
Dosage: TABLET; SUSPENSION
How can I launch a generic of FYCOMPA before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of FYCOMPA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the FYCOMPA's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on FYCOMPA:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 20 Dec, 2022 | 01 Jul, 2026 | Less | |||
| 24 Oct, 2016 | 01 Jul, 2026 | Eligible | 23 May, 2025 | Less |
More Information on Dosage
FYCOMPA family patents
5. Halaven patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| USRE46965 | EISAI | Intermediates for the preparation of analogs of Halichondrin B |
Jan, 2027
(10 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2015 |
| New Indication(I-721) | Jan 28, 2019 |
| Orphan Drug Exclusivity(ODE) | Jan 28, 2023 |
| Orphan Drug Exclusivity(ODE-107) | Jan 28, 2023 |
| M(M-280) | Sep 13, 2025 |
| Pediatric Exclusivity(PED) | Mar 13, 2026 |
Drugs and Companies using ERIBULIN MESYLATE ingredient
NCE-1 date: 15 November, 2014
Market Authorisation Date: 15 November, 2010
Treatment: NA
Dosage: SOLUTION
How can I launch a generic of HALAVEN before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of HALAVEN's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the HALAVEN's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on HALAVEN:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 20 Dec, 2019 | 08 Jan, 2027 | Extinguished | Less |
More Information on Dosage
HALAVEN family patents
6. Janumet Xr patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7326708 | MERCK | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
Nov, 2026
(8 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-244) | Aug 12, 2022 |
| Pediatric Exclusivity(PED) | Jun 04, 2024 |
| M(M-187) | Dec 04, 2023 |
Drugs and Companies using METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ingredient
Market Authorisation Date: 02 February, 2012
Treatment: Method of treating type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin hcl extended release is appropriate
Dosage: TABLET, EXTENDED RELEASE
How can I launch a generic of JANUMET XR before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of JANUMET XR's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the JANUMET XR's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on JANUMET XR:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 22 Oct, 2012 | 24 Nov, 2026 | Eligible | 04 Jun, 2025 | Less | |
| 16 Mar, 2012 | 24 Nov, 2026 | Eligible | 04 Jun, 2025 | Less |
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JANUMET XR family patents
7. Juvisync patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US7326708 | MERCK | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
Apr, 2026
(a month from now) | |
Drugs and Companies using SIMVASTATIN; SITAGLIPTIN PHOSPHATE ingredient
Market Authorisation Date: 18 September, 2012
Treatment: Method of treating type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Dosage: TABLET
How can I launch a generic of JUVISYNC before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of JUVISYNC's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the JUVISYNC's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on JUVISYNC:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 06 Nov, 2012 | 11 Apr, 2026 | Extinguished | Less | ||
| 25 Jun, 2012 | 11 Apr, 2026 | Extinguished | Less | ||
| 19 Jun, 2012 | 11 Apr, 2026 | Extinguished | Less |
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JUVISYNC family patents
8. Lyrica Cr patent expiration
The table below displays the last qualifying patent listed at the time of the Paragraph IV filing. This patent determined eligibility for 180-day exclusivity. Patents granted or listed after the Para IV submission are not considered for exclusivity qualification.
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9144559 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(8 months from now) | |
| US10022447 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(8 months from now) | |
| US8945620 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(8 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 11, 2020 |
| Pediatric Exclusivity(PED) | Apr 11, 2021 |
Drugs and Companies using PREGABALIN ingredient
Market Authorisation Date: 11 October, 2017
Treatment: Treatment of neuropathic pain associated with diabetic peripheral neuropathy; Treatment of postherpetic neuralgia
Dosage: TABLET, EXTENDED RELEASE
How can I launch a generic of LYRICA CR before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of LYRICA CR's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the LYRICA CR's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Here are the details of the already filed Para IV certificates on LYRICA CR:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 02 Feb, 2018 | 02 Nov, 2026 | Extinguished | 12 Apr, 2021 | Less | |
| 29 Jan, 2018 | 02 Nov, 2026 | Extinguished | 12 Apr, 2021 | Less |
More Information on Dosage
LYRICA CR family patents