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

Generic competition · all medicines · read 12 November 2026

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

Glycopyrrolate appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 35 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 11 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.
Glycopyrrolate7 dosage-form groups in the Orange Book
35generic makers listed
  1. Glycopyrrolate appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 35 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 11 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: Robinul and Robinul Forte. 13 generic makers with 25 generic products listed as marketed; the first generic approval is dated 22 December 2004.

200520102015202020252030013Ph Health Ltd, first approval 31 August 2006Chartwell Rx Sciences Llc, first approval 21 March 2008Rising Pharma Holdings Inc, first approval 29 December 2008Sun Pharmaceutical Industries Ltd, first approval 18 August 2009Tp Anda Holdings Llc, first approval 19 October 2011Lgm Pharma Solutions Llc, first approval 12 March 2012Velzen Pharma Pvt Ltd, first approval 21 September 2012Aurobindo Pharma Ltd, first approval 15 April 2013Regcon Holdings Llc, first approval 3 February 2014Natco Pharma Ltd, first approval 20 June 2016Appco Pharma Llc, first approval 3 January 2017Alembic Pharmaceuticals Ltd, first approval 30 November 2018Quagen Pharmaceuticals Llc, first approval 10 July 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ph Health Ltd31 August 20062
Chartwell Rx Sciences Llc21 March 20082
Rising Pharma Holdings Inc29 December 20082
Sun Pharmaceutical Industries Ltd18 August 20092
Tp Anda Holdings Llc19 October 20112
Lgm Pharma Solutions Llc12 March 20121
Velzen Pharma Pvt Ltd21 September 20122
Aurobindo Pharma Ltd15 April 20132
Regcon Holdings Llc3 February 20142
Natco Pharma Ltd20 June 20162
Appco Pharma Llc3 January 20172
Alembic Pharmaceuticals Ltd30 November 20182

1 more makers are listed in the data.

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

Brand listed as marketed: Robinul. 16 generic makers with 18 generic products listed as marketed; the first generic approval is dated 24 June 1983.

1985199019952000200520102015202020252030016American Regent Inc, first approval 23 July 1986Hikma Farmaceutica (Portugal) Sa, first approval 21 September 2011Amneal Eu Ltd, first approval 15 June 2017Somerset Therapeutics Llc, first approval 23 June 2017Fresenius Kabi Usa Llc, first approval 27 October 2017Piramal Critical Care Inc, first approval 25 October 2018Prinston Pharmaceutical Inc, first approval 31 October 2018Caplin Steriles Ltd, first approval 20 March 2019Sandoz Inc, first approval 14 May 2019Gland Pharma Ltd, first approval 30 September 2019Sagent Pharmaceuticals, first approval 21 February 2020Accord Healthcare Inc, first approval 8 July 2020Meitheal Pharmaceuticals Inc, first approval 6 July 2021Nivagen Pharmaceuticals Llc, first approval 13 October 2021Alembic Pharmaceuticals Ltd, first approval 26 October 2022Omnivium Pharmaceuticals Llc, first approval 29 November 2022data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
American Regent Inc23 July 19861
Hikma Farmaceutica (Portugal) Sa21 September 20111
Amneal Eu Ltd15 June 20172
Somerset Therapeutics Llc23 June 20171
Fresenius Kabi Usa Llc27 October 20172
Piramal Critical Care Inc25 October 20181
Prinston Pharmaceutical Inc31 October 20181
Caplin Steriles Ltd20 March 20191
Sandoz Inc14 May 20191
Gland Pharma Ltd30 September 20191
Sagent Pharmaceuticals21 February 20201
Accord Healthcare Inc8 July 20201

4 more makers are listed in the data.

Patents and exclusivities still listed

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

Solution, Oral

Four or more generic makers listed

Brand listed as marketed: Cuvposa. 11 generic makers with 11 generic products listed as marketed; the first generic approval is dated 9 August 2021.

20102015202020252030011brand 2010Ph Health Ltd, first approval 9 August 2021Annora Pharma Private Ltd, first approval 5 July 2022Cohance Lifesciences Ltd, first approval 5 July 2022Granules Pharmaceuticals Inc, first approval 19 August 2024Chartwell Rx Sciences Llc, first approval 28 August 2024Sciegen Pharmaceuticals Inc, first approval 7 October 2024Aurobindo Pharma Ltd, first approval 31 December 2024Msn Laboratories Private Ltd, first approval 8 April 2025Ajenat Pharmaceuticals Llc, first approval 27 October 2025Bionpharma Inc, first approval 23 December 2025Quagen Pharmaceuticals Llc, first approval 18 May 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ph Health Ltd9 August 20211
Annora Pharma Private Ltd5 July 20221
Cohance Lifesciences Ltd5 July 20221
Granules Pharmaceuticals Inc19 August 20241
Chartwell Rx Sciences Llc28 August 20241
Sciegen Pharmaceuticals Inc7 October 20241
Aurobindo Pharma Ltd31 December 20241
Msn Laboratories Private Ltd8 April 20251
Ajenat Pharmaceuticals Llc27 October 20251
Bionpharma Inc23 December 20251
Quagen Pharmaceuticals Llc18 May 20261

Patents and exclusivities still listed

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

Solution, Intramuscular, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Glycopyrrolate and Glyrx-Pf. No generic is listed as marketed.

201520202025203001brand 2018data 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.

Tablet, Orally Disintegrating, Oral

Nothing listed as marketed

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

20202025203001brand 2021data 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.

Powder, Inhalation

Nothing listed as marketed

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

201520202025203001brand 2015data 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, Inhalation

Nothing listed as marketed

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

201520202025203001brand 2017data 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.