Mylan Drug Patent Portfolio
Mylan owns 7 orange book drugs protected by 39 US patents with Ermeza having the least patent protection, holding only 1 patent. And Yupelri with maximum patent protection, holding 21 patents. Given below is the list of Mylan's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11484531 | Methods for treating chronic obstructive pulmonary disease | 23 Oct, 2039 | Active |
| US12048692 | Methods for treating chronic obstructive pulmonary disease | 29 Aug, 2039 | Active |
| US12285417 | Methods for treating chronic obstructive pulmonary disease | 29 Aug, 2039 | Active |
| US9345772 | Liquid levothyroxine formulations | 27 Feb, 2035 | Active |
| US8541451 | Crystalline freebase forms of a biphenyl compound | 25 Aug, 2031 | Active |
| US10550081 | Crystalline freebase forms of a biphenyl compound | 14 Jul, 2030 | Active |
| US11008289 | Crystalline freebase forms of a biphenyl compound | 14 Jul, 2030 | Active |
| US11691948 | Crystalline freebase forms of a biphenyl compound | 14 Jul, 2030 | Active |
| US11858898 | Crystalline freebase forms of a biphenyl compound | 14 Jul, 2030 | Active |
| US9765028 | Crystalline freebase forms of a biphenyl compound | 14 Jul, 2030 | Active |
| US7288657 | Biphenyl compounds useful as muscarinic receptor antagonists | 31 Oct, 2028 | Active |
| US8147852 | Modified azole compounds as antifungal and antibacterial agents | 30 Mar, 2028 | Active |
| US7645801 | Reduced irritant enema for treatment of inflammatory bowel disease (IBD) | 24 Jul, 2027 | Active |
| US8168620 | Combination of azelastine and steroids | 24 Aug, 2026 | Active |
| US8168620 | Combination of azelastine and steroids | 24 Feb, 2026 | Active |
| US10106503 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US10343995 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US11247969 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US7491736 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US7521041 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US7550595 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US7585879 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US7910608 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US8034946 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US8053448 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US8273894 | Biphenyl compounds useful as muscarinic receptor antagonists | 10 Mar, 2025 | Expired |
| US8163723 | Combination of azelastine and steroids | 29 Feb, 2024 | Expired |
| US9259428 | Combination of azelastine and fluticasone for nasal administration | 13 Dec, 2023 | Expired |
| US8163723 | Combination of azelastine and steroids | 29 Aug, 2023 | Expired |
| US9259428 | Combination of azelastine and fluticasone for nasal administration | 13 Jun, 2023 | Expired |
| US9901585 | Combination of azelastine and fluticasone for nasal administration | 13 Jun, 2023 | Expired |
| US6579981 | Antiviral guanine derivatives | 17 Jun, 2020 | Expired |
| US6469015 | Pharmaceutical formulation | 22 Oct, 2019 | Expired |
| US5866591 | Stable formulations of remifentanil | 10 Mar, 2018 | Expired |
| US5866591 | Stable formulations of remifentanil | 10 Sep, 2017 | Expired |
| US5840763 | Treatment of a latent infection of herpes viruses | 01 Sep, 2015 | Expired |
| US5916893 | Treatment of a latent infection of herpes virus | 01 Sep, 2015 | Expired |
| US5866581 | Penciclovir for the treatment of post therapeutic neuralgia | 04 Oct, 2014 | Expired |
| US6124304 | Penciclovir for the treatment of zoster associated pain | 04 Oct, 2014 | Expired |
Latest Legal Activities on Mylan's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Mylan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
|
Expire Patent
Critical
| 03 Jun, 2024 | US8168620 (Litigated) |
|
Expire Patent
Critical
| 27 May, 2024 | US8163723 (Litigated) |
|
Change in Power of Attorney (May Include Associate POA)
Critical
| 03 May, 2024 | US7585879 |
|
Email Notification
Critical
| 03 May, 2024 | US7585879 |
|
Email Notification
Critical
| 25 Apr, 2024 | US7288657 |
|
Change in Power of Attorney (May Include Associate POA)
Critical
| 25 Apr, 2024 | US7288657 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Mar, 2024 | US8273894 |
|
Expire Patent
Critical
| 25 Mar, 2024 | US9259428 (Litigated) |
| Notice of Final Determination -Election Required | 22 Mar, 2024 | US7585879 |
| Notice of Final Determination -Election Required | 22 Mar, 2024 | US7288657 |
| Mail Patent eCofC Notification | 20 Feb, 2024 | US11858898 |
| Recordation of Patent eCertificate of Correction | 20 Feb, 2024 | US11858898 |
| Patent eCofC Notification | 20 Feb, 2024 | US11858898 |
|
Email Notification
Critical
| 20 Feb, 2024 | US11858898 |
| Post Issue Communication - Certificate of Correction | 31 Jan, 2024 | US11858898 |
Mylan's Drug Patent Litigations
Mylan's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 14, 2000, against patent number US6579981. The petitioner , challenged the validity of this patent, with JARVEST et al as the respondent. Click below to track the latest information on how companies are challenging Mylan's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8163723 | January, 2020 |
Institution Denied
(31 Jul, 2020)
| Cipla Limited et al. | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8163723 | January, 2020 |
Terminated-Denied
(31 Jul, 2020)
| Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8168620 | January, 2020 |
Institution Denied
(31 Jul, 2020)
| Cipla Limited et al. | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8168620 | January, 2020 |
Terminated-Denied
(31 Jul, 2020)
| Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9259428 | January, 2020 |
Institution Denied
(31 Jul, 2020)
| Cipla Limited et al. | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9259428 | January, 2020 |
Terminated-Denied
(31 Jul, 2020)
| Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9901585 | January, 2020 |
Institution Denied
(31 Jul, 2020)
| Cipla Limited et al. | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9901585 | January, 2020 |
Terminated-Denied
(31 Jul, 2020)
| Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8168620 | February, 2017 |
Terminated-Settled
(21 May, 2018)
| Cipla Limited | Argentum Pharmaceuticals LLC |
| US8147852 | November, 2010 |
Decision
(08 Aug, 2011)
| Marcel Borgers et al | |
| US7645801 | April, 2008 |
Decision
(08 Dec, 2008)
| Bala VENKATARAMAN et al | |
| US6579981 | January, 2000 |
Decision
(26 Sep, 2002)
| JARVEST et al | |
| US6579981 | January, 2000 |
Decision
(04 Jul, 1776)
| JARVEST et al | |
Mylan Drug Patents' Oppositions Filed in EPO
Mylan drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 14, 2010, by Glaxo Group Limited. This opposition was filed on patent number EP03738280A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09075100A | Apr, 2016 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP09075101A | Oct, 2014 | Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi | Revoked |
| EP09075101A | Oct, 2014 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP03738280A | Jan, 2010 | Glaxo Group Limited | Revoked |
Mylan's Family Patents
Recent FDA approvals and tentative approvals for Mylan
This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.
Innovator drugs
Includes innovator drug submissions that appear in FDA approval and tentative approval disclosures.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Efavirenz, Emtricitabine And Tenofovir Alafenamide |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 4 - New Combination | 22 Mar, 2024 |
| Darunavir And Ritonavir |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 4 - New Combination | 22 Dec, 2023 |
| Dolutegravir, Lamivudine, And Tenofovir Disoproxil Fumarate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 4 - New Combination | 02 Aug, 2017 |
Generic drugs
Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Aprepitant |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 17 Nov, 2025 |
| Sugammadex |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 20 Nov, 2024 |
| Paliperidone Palmitate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 20 May, 2024 |
Mylan Drug List
Given below is the complete list of Mylan's drugs and the patents protecting them.
1. Denavir
Denavir is protected by 6 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US6579981 | Antiviral guanine derivatives |
17 Jun, 2020
(5 years ago)
| Expired |
| US6469015 | Pharmaceutical formulation |
22 Oct, 2019
(6 years ago)
| Expired |
| US5840763 | Treatment of a latent infection of herpes viruses |
01 Sep, 2015
(10 years ago)
| Expired |
| US5916893 | Treatment of a latent infection of herpes virus |
01 Sep, 2015
(10 years ago)
| Expired |
| US5866581 | Penciclovir for the treatment of post therapeutic neuralgia |
04 Oct, 2014
(11 years ago)
| Expired |
| US6124304 | Penciclovir for the treatment of zoster associated pain |
04 Oct, 2014
(11 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Denavir's drug page
2. Dymista
Dymista is protected by 7 patents, out of which 5 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US8168620
(Pediatric)
| Combination of azelastine and steroids |
24 Aug, 2026
(7 months from now)
| Active |
| US8168620 | Combination of azelastine and steroids |
24 Feb, 2026
(a month from now)
| Active |
| US8163723
(Pediatric)
| Combination of azelastine and steroids |
29 Feb, 2024
(1 year, 10 months ago)
| Expired |
| US9259428
(Pediatric)
| Combination of azelastine and fluticasone for nasal administration |
13 Dec, 2023
(2 years ago)
| Expired |
| US8163723 | Combination of azelastine and steroids |
29 Aug, 2023
(2 years ago)
| Expired |
| US9259428 | Combination of azelastine and fluticasone for nasal administration |
13 Jun, 2023
(2 years ago)
| Expired |
| US9901585 | Combination of azelastine and fluticasone for nasal administration |
13 Jun, 2023
(2 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Dymista's drug page
3. Ermeza
Ermeza is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US9345772 | Liquid levothyroxine formulations |
27 Feb, 2035
(9 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Ermeza's drug page
4. Sfrowasa
Sfrowasa is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US7645801 | Reduced irritant enema for treatment of inflammatory bowel disease (IBD) |
24 Jul, 2027
(1 year, 6 months from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Sfrowasa's drug page
5. Ultiva
Ultiva is protected by 2 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US5866591
(Pediatric)
| Stable formulations of remifentanil |
10 Mar, 2018
(7 years ago)
| Expired |
| US5866591 | Stable formulations of remifentanil |
10 Sep, 2017
(8 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Ultiva's drug page
Explore Our Curated Drug Screens
6. Vusion
Vusion is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US8147852 | Modified azole compounds as antifungal and antibacterial agents |
30 Mar, 2028
(2 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Vusion's drug page
7. Yupelri
Yupelri is protected by 21 patents, out of which 11 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11484531 | Methods for treating chronic obstructive pulmonary disease |
23 Oct, 2039
(13 years from now)
| Active |
| US12048692 | Methods for treating chronic obstructive pulmonary disease |
29 Aug, 2039
(13 years from now)
| Active |
| US12285417 | Methods for treating chronic obstructive pulmonary disease |
29 Aug, 2039
(13 years from now)
| Active |
| US8541451 | Crystalline freebase forms of a biphenyl compound |
25 Aug, 2031
(5 years from now)
| Active |
| US10550081 | Crystalline freebase forms of a biphenyl compound |
14 Jul, 2030
(4 years from now)
| Active |
| US11008289 | Crystalline freebase forms of a biphenyl compound |
14 Jul, 2030
(4 years from now)
| Active |
| US11691948 | Crystalline freebase forms of a biphenyl compound |
14 Jul, 2030
(4 years from now)
| Active |
| US11858898 | Crystalline freebase forms of a biphenyl compound |
14 Jul, 2030
(4 years from now)
| Active |
| US9765028 | Crystalline freebase forms of a biphenyl compound |
14 Jul, 2030
(4 years from now)
| Active |
| US7288657 | Biphenyl compounds useful as muscarinic receptor antagonists |
31 Oct, 2028
(2 years from now)
| Active |
| US10106503 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US10343995 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US11247969 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US7491736 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US7521041 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US7550595 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US7585879 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US7910608 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US8034946 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US8053448 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
| US8273894 | Biphenyl compounds useful as muscarinic receptor antagonists |
10 Mar, 2025
(9 months ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Yupelri's drug page