FDA Orange Book · active-ingredient family
Glycopyrrolate
Glycopyrrolate: 9 brands, 59 generics; first approved Jun 24, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 59 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
9
Generics (ANDA)
59
Listed patents
11
Next patent expiry
Aug 16, 2026
2 mo ago
Brand (NDA) products
Originator applications
- GLYCOPYRROLATERLDRSFRESENIUS KABI USANDA 2149192022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.6MG/3ML (0.2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — - DARTISLA ODTRLDEDENBRIDGE PHARMSNDA 21501920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.7MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 0.85MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - GLYRX-PFRLDEXELA PHARMANDA 21099720184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML (0.2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — 0.4MG/2ML (0.2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — 1MG/5ML (0.2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — 0.6MG/3ML (0.2MG/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - SUMITOMO PHARMA AMNDA 2084372017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MCG/ML SOLUTION INHALATION Discontinued — - NOVARTISNDA 2079232015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15.6MCG/INH POWDER INHALATION Discontinued — - MERZ PHARMSNDA 0225712010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - ROBINULRLDHIKMANDA 017558—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - ROBINULRLDCASPER PHARMA LLCNDA 012827—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - ROBINS AHNDA 014764—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (59)
Abbreviated applications
- GLYCOPYRROLATEQUAGENANDA 2169102026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEBIONPHARMAANDA 2200622025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEAJENAT PHARMSANDA 2192672025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEMSNANDA 2160842025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEAUROBINDO PHARMA LTDANDA 2148472024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATESCIEGEN PHARMSANDA 2162972024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATECHARTWELL RXANDA 2163682024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEGRANULESANDA 2147352024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEQUAGENANDA 21269620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEMANKIND PHARMAANDA 2173542023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATELUPINANDA 2136552023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEOMNIVIUM PHARMSANDA 2128712022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEALEMBICANDA 2146352022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEAMNEALANDA 2153332022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEANNORA PHARMAANDA 2136982022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATESUVEN PHARMSANDA 2124672022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEZYDUS PHARMSANDA 2142132021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATENIVAGENANDA 2125912021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEPH HEALTHANDA 2044382021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML SOLUTION ORAL Rx AA - GLYCOPYRROLATEMEITHEALANDA 2128022021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEXIROMEDANDA 2122272021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEACCORD HLTHCAREANDA 2132382020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATESAGENTANDA 2100832020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEAPOTEXANDA 2102462019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEGLANDANDA 2126122019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATESANDOZANDA 2113342019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATECAPLINANDA 2117052019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEALEMBICANDA 20365720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEEUGIA PHARMAANDA 2102442018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEFRESENIUS KABI USAANDA 2090242018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEPRINSTON INCANDA 2109272018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEPIRAMAL CRITICALANDA 2108422018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEFRESENIUS KABI USAANDA 2093282017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATESOMERSET THERAPS LLCANDA 2076392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEAMNEALANDA 2089732017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEAPPCOANDA 20720120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATENATCOANDA 09141320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEREGCON HOLDINGSANDA 09118220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEAUROBINDO PHARMAANDA 20267520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEVELZEN PHARMA PVTANDA 09019520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATERSLGM PHARMAANDA 0915222012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Rx — - GLYCOPYRROLATEOXFORD PHARMSANDA 09002020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATERSHIKMA FARMACEUTICAANDA 0909632011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATESUN PHARM INDS LTDANDA 04084420092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATEHIKMA INTL PHARMSANDA 04083620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - GLYCOPYRROLATERISINGANDA 04082120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATECHARTWELL RXANDA 04084720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATERSPH HEALTHANDA 04065320062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - GLYCOPYRROLATECHARTWELL RXANDA 04056820042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - GLYCOPYRROLATETEVA PARENTERALANDA 0811691991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEHOSPIRAANDA 0893931988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEAM REGENTANDA 0893351986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Rx AP - GLYCOPYRROLATEABRAXIS PHARMANDA 0884751984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 0869471983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/ML INJECTABLE INJECTION Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 085562—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 086902—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 085563—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 086178—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - GLYCOPYRROLATEWATSON LABSANDA 086900—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11278683 | 2 mo ago | Product | |
| 8479730 | in 2 yr | Product | |
| 8182838 | in 2 yr 1 mo | Product | |
| 9265900 | in 2 yr 2 mo | Product | |
| 10940110 | in 2 yr 5 mo | ProductU-1773 | |
| 9789270 | in 4 yr 1 mo | Product | |
| 9168556 | in 6 yr | Product | |
| 9604018 | in 6 yr 8 mo | Product | |
| 10376661 | in 9 yr 1 mo | Product | |
| 10688518 | in 10 yr 3 mo | Product | |
| 10744277 | in 10 yr 4 mo | ProductU-2941 |
Approval history
FDA approval span
First approval
43 yr 11 mo ago
Most recent approval
5 mo ago
Approvals span 1983–2026 across 68 FDA applications.
Brand (NDA) 913%
Generic (ANDA) 5987%
Glycopyrrolate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
