interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Azithromycin

Generic competition · all medicines · read 12 November 2026

Is there a generic of Azithromycin, and who makes it?

Azithromycin appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 8.9 and 11.8 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Azithromycin6 dosage-form groups in the Orange Book
19generic makers listed
  1. Azithromycin appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came between 8.9 and 11.8 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Zithromax. 11 generic makers with 28 generic products listed as marketed; the first generic approval is dated 14 November 2005.

19952000200520102015202020252030011brand 1996Pliva Inc, first approval 14 November 2005Sandoz Inc, first approval 14 November 2005Teva Pharmaceuticals Usa Inc, first approval 14 November 2005Chartwell Rx Sciences Llc, first approval 11 February 2008Lupin Ltd, first approval 15 May 2015Aurobindo Pharma Ltd, first approval 5 July 2018Cspc Ouyi Pharmaceutical Co Ltd, first approval 24 September 2018Sunshine Lake Pharma Co Ltd, first approval 6 December 2018Bionpharma Inc, first approval 26 December 2018Alembic Pharmaceuticals Ltd, first approval 27 January 2020Carlsbad Technology Inc, first approval 8 May 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Pliva Inc14 November 20053
Sandoz Inc14 November 20053
Teva Pharmaceuticals Usa Inc14 November 20051
Chartwell Rx Sciences Llc11 February 20083
Lupin Ltd15 May 20153
Aurobindo Pharma Ltd5 July 20182
Cspc Ouyi Pharmaceutical Co Ltd24 September 20183
Sunshine Lake Pharma Co Ltd6 December 20183
Bionpharma Inc26 December 20183
Alembic Pharmaceuticals Ltd27 January 20203
Carlsbad Technology Inc8 May 20201

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

For Suspension, Oral

Four or more generic makers listed

Brand listed as marketed: Zithromax. 6 generic makers with 12 generic products listed as marketed; the first generic approval is dated 5 July 2006.

19901995200020052010201520202025203006brand 1994Pliva Inc, first approval 5 July 2006Chartwell Rx Sciences Llc, first approval 15 May 2015Epic Pharma Llc, first approval 9 April 2018Zydus Lifesciences Global Fze, first approval 31 July 2018Aurobindo Pharma Ltd, first approval 9 October 2018Zhejiang Poly Pharm Co Ltd, first approval 27 July 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Pliva Inc5 July 20062
Chartwell Rx Sciences Llc15 May 20152
Epic Pharma Llc9 April 20182
Zydus Lifesciences Global Fze31 July 20182
Aurobindo Pharma Ltd9 October 20182
Zhejiang Poly Pharm Co Ltd27 July 20232

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Injectable, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 13 December 2005.

1995200020052010201520202025203005brand 1997Fresenius Kabi Usa Llc, first approval 13 December 2005Hospira Inc, first approval 26 June 2009Gland Pharma Ltd, first approval 9 November 2009Eugia Pharma Specialities Ltd, first approval 19 June 2015Hainan Poly Pharm Co Ltd, first approval 9 October 2018data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc13 December 20051
Hospira Inc26 June 20091
Gland Pharma Ltd9 November 20091
Eugia Pharma Specialities Ltd19 June 20151
Hainan Poly Pharm Co Ltd9 October 20181

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Capsule, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

19901995200020052010201520202025203001brand 1991data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

For Suspension, Extended Release, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

20052010201520202025203001brand 2005data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution/Drops, Ophthalmic

Brand listed, no generic listed as marketed

Brand listed as marketed: Azasite. No generic is listed as marketed.

20052010201520202025203001brand 2007data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.