Innovator Drugs Facing Paragraph IV Filings
Drugs approaching patent expiration that have been challenged through Paragraph IV filings with limited generic competition
1. Belbuca patent expiration
Can you believe BELBUCA received compensation for the extended wait time during the regulatory approval process?
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). | ||||
| US8147866 | BDSI | Transmucosal delivery devices with enhanced uptake |
Jul, 2027
(11 months from now) | |
| US9655843 | BDSI | Transmucosal delivery devices with enhanced uptake |
Jul, 2027
(11 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 23, 2018 |
Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE ingredient
Market Authorisation Date: 23 October, 2015
Treatment: Treatment of pain by transmucosal delivery of buprenorphine; Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options...
Dosage: FILM
How can I launch a generic of BELBUCA before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of BELBUCA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the BELBUCA'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 BELBUCA:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 24 Oct, 2016 | 23 Jul, 2027 | Extinguished Non-Forfeiture | Less | ||
| 04 Oct, 2016 | 23 Jul, 2027 | Extinguished Non-Forfeiture | Less | ||
| 12 Sep, 2016 | 23 Jul, 2027 | Extinguished Non-Forfeiture | Less |
More Information on Dosage
BELBUCA 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
(3 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 |
More Information on Dosage
BOSULIF family patents
3. Dificid 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. | ||||
| US7863249 | CUBIST | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof |
Jul, 2027
(11 months from now) | |
| US7378508 | CUBIST | Polymorphic crystalline forms of tiacumicin B |
Jul, 2027
(11 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US8859510 | CUBIST | Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof |
Jul, 2027
(11 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 27, 2016 |
| New Product(NP) | Jan 24, 2023 |
| New Patient Population(NPP) | Jan 24, 2023 |
| Pediatric Exclusivity(PED) | Jul 24, 2023 |
| Orphan Drug Exclusivity(ODE-367) | Jan 24, 2027 |
Drugs and Companies using FIDAXOMICIN ingredient
NCE-1 date: 28 May, 2015
Market Authorisation Date: 27 May, 2011
Treatment: Treatment of clostridioides difficile-associated diarrhea (cdad) in patients from 6 months of age and older
Dosage: TABLET
How can I launch a generic of DIFICID before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of DIFICID's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the DIFICID'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 DIFICID:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 27 May, 2015 | 31 Jul, 2027 | Deferred | 16 Jan, 2024 | Less |
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DIFICID family patents
4. 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
(13 days 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 |
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DYMISTA 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
(4 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
(3 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. Lenvima 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). | ||||
| US9006256 | EISAI | Antitumor agent for thyroid cancer |
Jul, 2027
(11 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-734) | May 13, 2019 |
| New Chemical Entity Exclusivity(NCE) | Feb 13, 2020 |
| New Indication(I-787) | Aug 15, 2021 |
| Orphan Drug Exclusivity(ODE) | Feb 13, 2022 |
| Orphan Drug Exclusivity(ODE-87) | Feb 13, 2022 |
| New Indication(I-807) | Sep 17, 2022 |
| M(M-269) | Jul 21, 2024 |
| New Indication(I-868) | Aug 10, 2024 |
| M(M-272) | Dec 19, 2024 |
| Orphan Drug Exclusivity(ODE-196) | Aug 15, 2025 |
| M(M-14) | Apr 03, 2027 |
| Pediatric Exclusivity(PED) | Oct 03, 2027 |
Drugs and Companies using LENVATINIB MESYLATE ingredient
NCE-1 date: 13 February, 2019
Market Authorisation Date: 13 February, 2015
Treatment: Method for treating thyroid carcinoma including differentiated thyroid cancer
Dosage: CAPSULE
How can I launch a generic of LENVIMA before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of LENVIMA's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the LENVIMA'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 LENVIMA:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Feb, 2019 | 27 Jul, 2027 | Less |
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LENVIMA 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). | ||||
| US10022447 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(2 months from now) | |
| US9144559 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(2 months from now) | |
| US8945620 | UPJOHN | Solid pharmaceutical compositions containing pregabalin |
Nov, 2026
(2 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
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 |
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LYRICA CR family patents
9. Oxtellar 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 focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US11166960 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US7722898 | SUPERNUS | Modified-release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US7910131 | SUPERNUS | Method of treating seizures using modified release formulations of oxcarbazepine |
Apr, 2027
(8 months from now) | |
| US8617600 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US8821930 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US9119791 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US9351975 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US9370525 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US9855278 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US10220042 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| US11896599 | SUPERNUS | Modified release preparations containing oxcarbazepine and derivatives thereof |
Apr, 2027
(8 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Oct 19, 2015 |
Drugs and Companies using OXCARBAZEPINE ingredient
Market Authorisation Date: 19 October, 2012
Treatment: Treatment of partial-onset seizures
Dosage: TABLET, EXTENDED RELEASE
How can I launch a generic of OXTELLAR XR before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of OXTELLAR XR's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the OXTELLAR 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 OXTELLAR XR:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 12 Apr, 2013 | 13 Apr, 2027 | Extinguished | Less | ||
| 20 Mar, 2013 | 13 Apr, 2027 | Extinguished | Less |
More Information on Dosage
OXTELLAR XR family patents
10. Picato 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). | ||||
| US8278292 | LEO | Therapeutic compositions |
Jul, 2027
(10 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 23, 2017 |
| M(M-169) | Nov 19, 2018 |
Drugs and Companies using INGENOL MEBUTATE ingredient
NCE-1 date: 24 January, 2016
Market Authorisation Date: 23 January, 2012
Treatment: NA
Dosage: GEL
How can I launch a generic of PICATO before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of PICATO's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the PICATO'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 PICATO:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 27 Jan, 2016 | 06 Jul, 2027 | Eligible | 09 Jan, 2019 | Less | |
| 27 Jan, 2016 | 06 Jul, 2027 | Eligible | 07 Jan, 2019 | Less |
More Information on Dosage
PICATO family patents
11. Vyndaqel 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. | ||||
| US7214695 | FOLDRX | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding |
Dec, 2026
(4 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US7214696 | FOLDRX | Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding |
Dec, 2026
(4 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 03, 2024 |
| Orphan Drug Exclusivity(ODE-237) | May 03, 2026 |
Drugs and Companies using TAFAMIDIS MEGLUMINE ingredient
NCE-1 date: 04 May, 2023
Market Authorisation Date: 03 May, 2019
Treatment: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (attr-cm)
Dosage: CAPSULE
How can I launch a generic of VYNDAQEL before its drug patent expiration?
You can seek FDA approval to launch a generic drug before the expiration of VYNDAQEL's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the VYNDAQEL'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 VYNDAQEL:-
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 03 May, 2023 | 19 Dec, 2026 | Less |
More Information on Dosage
VYNDAQEL family patents