Alembic Drug Patent Portfolio

Alembic owns 1 orange book drug protected by 7 US patents Given below is the list of Alembic's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10238634 Aqueous-based metronidazole gel formulations 28 Jun, 2032
Active
US10596155 Aqueous-based metronidazole gel formulations 28 Jun, 2032
Active
US8946276 High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis 28 Jun, 2032
Active
US9198858 Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations 28 Jun, 2032
Active
US8658678 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water 27 Jun, 2028
Active
US7893097 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water 19 Feb, 2028
Active
US8877792 Compositions for increasing solubility of azole drug compounds that are poorly soluble in water 02 Feb, 2028
Active


Given below is the list of recent legal activities going on the following drug patents of Alembic.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 23 Jul, 2025 US8658678
Payment of Maintenance Fee, 4th Year, Large Entity 25 Sep, 2023 US10596155
Payment of Maintenance Fee, 8th Year, Large Entity 01 Jun, 2023 US9198858
Payment of Maintenance Fee, 4th Year, Large Entity 26 Sep, 2022 US10238634
Payment of Maintenance Fee, 8th Year, Large Entity 03 Aug, 2022 US8946276
Payment of Maintenance Fee, 12th Year, Large Entity 20 Jul, 2022 US7893097
Payment of Maintenance Fee, 8th Year, Large Entity 21 Apr, 2022 US8877792
Payment of Maintenance Fee, 8th Year, Large Entity 27 Jul, 2021 US8658678
Patent Issue Date Used in PTA Calculation 24 Mar, 2020 US10596155
Recordation of Patent Grant Mailed 24 Mar, 2020 US10596155
Issue Notification Mailed 04 Mar, 2020 US10596155
Dispatch to FDC 20 Feb, 2020 US10596155
Application Is Considered Ready for Issue 14 Feb, 2020 US10596155
Issue Fee Payment Received 07 Feb, 2020 US10596155
Issue Fee Payment Verified 07 Feb, 2020 US10596155


Alembic's Family Patents

Alembic drugs have patent protection in a total of 9 countries. It has a significant patent presence in the US with 55.6% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree.

Family Patents



Recent FDA approvals and tentative approvals for Alembic

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


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
Binimetinib ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 18 Jun, 2026
Bosutinib Monohydrate SUPPL-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
Manufacturing (CMC) 12 Jun, 2026
Ribociclib ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 10 Jan, 2024

Alembic Drug List

Given below is the complete list of Alembic's drugs and the patents protecting them.


1. Nuvessa

Nuvessa is protected by 7 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10238634 Aqueous-based metronidazole gel formulations 28 Jun, 2032
(6 years from now)
Active
US10596155 Aqueous-based metronidazole gel formulations 28 Jun, 2032
(6 years from now)
Active
US8946276 High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis 28 Jun, 2032
(6 years from now)
Active
US9198858 Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations 28 Jun, 2032
(6 years from now)
Active
US8658678 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water 27 Jun, 2028
(2 years from now)
Active
US7893097 Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water 19 Feb, 2028
(1 year, 7 months from now)
Active
US8877792 Compositions for increasing solubility of azole drug compounds that are poorly soluble in water 02 Feb, 2028
(1 year, 7 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 Nuvessa's drug page


Explore Our Curated Drug Screens

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NCE-1 Patent Expiry in the Next 1 Year
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