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Generic and biosimilar maker · US openings

Zydus

Zydus has no confirmed US launch yet among the blockbuster drugs on this tracker, holds FDA approval for 4 of them, and has 4 filed or in development. Those brands earned $102.1B in 2025. No other maker we follow is lined up to copy more of these drugs.

Ahmedabad, India · Listed: NSE (ZYDUSLIFE), as Zydus Lifesciences

Drugs targeted
1211 generic · 1 biosimilar
On the US market
0
Approved, not launched
4
Next opening
NowFarxiga and 2 more
2025 sales of those brands
$102.1B
Company revenue
Rs 271.5B in the year to March 2026North America formulations 40% of the business (Rs 116.8B, up 5.7%)

Approved, no US launch confirmed 4

DrugZydus' statusOther makers listed2025 brand sales
EntrestoGeneric · Novartis · US LOE 2025 FDA-approved 9 Jul 2024 2 on sale · 13 approvedof 15 other makers listed $7.7B
FarxigaGeneric · AstraZeneca · US LOE 2026 FDA-approved 6 Apr 2026; said it was eligible for 180-day shared exclusivity, which ended about 3 Oct 2026. Eligible for 180-day shared generic exclusivity 2 on sale · 12 approvedof 14 other makers listed $8.4B
OpsumitGeneric · Johnson & Johnson · US LOE 2026 FDA-approved 6 Apr 2021; first filer; FDA found it eligible for 180-day shared exclusivity, to about 3 Dec 2026 2 on sale · 9 approvedof 11 other makers listed $2.3B
ErleadaGeneric · Johnson & Johnson · US LOE 2033 FDA-approved 17 Mar 2025; settled Nov 2024, terms confidential. Not launched 0 on sale · 0 approvedof 3 other makers listed $3.6B

Approved but not marketed 4

DrugZydus' statusOther makers listed2025 brand sales
XtandiGeneric · Capsules · Astellas / Pfizer · US LOE 2027 Capsules: FDA-approved 26 Sep 2024, not marketed 0 on sale · 2 approvedof 5 other makers listed ≈$6.0B
JardianceGeneric · Boehringer Ingelheim / Eli Lilly · US LOE 2029 FDA-approved 3 Aug 2022, not marketed 0 on sale · 1 approvedof 1 other maker listed ≈$9.9B
VraylarGeneric · AbbVie · US LOE 2029 FDA-approved 9 Sep 2022, not marketed 0 on sale · 0 approvedof 2 other makers listed $3.6B
ImbruvicaGeneric · Capsules · AbbVie / Johnson & Johnson · US LOE 2032 Capsules: FDA-approved 31 Mar 2021, not marketed 0 on sale · 1 approvedof 2 other makers listed $4.0B

Filed with the FDA 4

DrugZydus' statusOther makers listed2025 brand sales
LynparzaGeneric · AstraZeneca / Merck · US LOE 2027 Filed with the FDA; in litigation 0 on sale · 1 approvedof 3 other makers listed $3.3B
Keytruda FYB206Biosimilar · Merck · US LOE 2028 Filed with the FDA 2026. FDA accepted the application for review in Oct 2026; decision expected Q3 2027
With Formycon
0 on sale · 0 approvedof 9 other makers listed $31.7B
OtezlaGeneric · Amgen · US LOE 2028 Filed with the FDA; barred by court until Feb 2028 0 on sale · 5 approvedof 8 other makers listed $2.3B
OzempicGeneric · Novo Nordisk · US LOE 2032 Filed with the FDA; settled, terms confidential 0 on sale · 1 approvedof 6 other makers listed ≈$19.3B

Next openings

Copies not yet on sale, by the earliest year each could reach the US market: a settlement or court date where one is public, otherwise the brand's US exclusivity date. "Now" means that date has passed. Court rulings and new patents can move these.

Makers on the same drugs

  • Cipla5 shared: Farxiga, Keytruda, Lynparza and Otezla and more
  • MSN5 shared: Entresto, Farxiga, Otezla and Erleada and more
  • Sandoz5 shared: Farxiga, Keytruda, Xtandi and Lynparza and more
  • Alembic4 shared: Entresto, Farxiga, Lynparza and Opsumit
  • Aurobindo4 shared: Entresto, Farxiga, Vraylar and Opsumit
  • Lupin4 shared: Entresto, Farxiga, Xtandi and Erleada

How to read this

Each row is a copy Zydus sells, holds an approval for, has filed, or is developing, for one of the 63 blockbuster drugs this site tracks. It is not Zydus' full portfolio. "Other makers listed" counts the other companies on the same drug's list: how many sell a copy and how many more hold an approval. Brand owners and the FDA don't always name every filer, so a list can be incomplete; the drug page says so where we know.

Brand sales

2025 sales are what each brand earned, the size of the market at stake. They are not Zydus' sales; several makers usually share a market once copies launch.

Sources

Every row is sourced on its drug's page: FDA Orange Book and Purple Book approvals, company releases and filings for launches, and court and company records for settlements. Company facts: Stock Analysis; Zydus results release, 19 May 2026.

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