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Glycopyrrolate - Generic Drug Details
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What are the generic sources for glycopyrrolate and what is the scope of patent protection?
Glycopyrrolate
is the generic ingredient in eight branded drugs marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal, Apotex, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Piramal Critical, Prinston Inc, Riconpharma Llc, Sandoz Inc, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Hikma, Robins Ah, Novartis, Sunovion Resp, Exela Pharma, Merz Pharms, Alembic Labs, Aurolife Pharma Llc, Dr Reddys Labs Ltd, Heritage Pharms Inc, Hikma Intl Pharms, Kenton, Leading Pharma Llc, Lgm Pharma, Natco Pharma Ltd, Oxford Pharms, Par Pharm, Renata, Rising, Sun Pharm Inds Ltd, and Casper Pharma Llc, and is included in forty-six NDAs. There are thirty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Glycopyrrolate has four hundred and fifteen patent family members in forty-one countries.
There are seventeen drug master file entries for glycopyrrolate. There is one tentative approval for this compound.
Summary for glycopyrrolate
International Patents: | 415 |
US Patents: | 32 |
Tradenames: | 8 |
Applicants: | 39 |
NDAs: | 46 |
Drug Master File Entries: | 17 |
Bulk Api Vendors: | 87 |
Clinical Trials: | 133 |
Patent Applications: | 4,255 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for glycopyrrolate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycopyrrolate |
DailyMed Link: | glycopyrrolate at DailyMed |
Recent Clinical Trials for glycopyrrolate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Temple University | Phase 4 |
Tanta University | Phase 1 |
Rajesh Deshar | N/A |
Generic filers with tentative approvals for GLYCOPYRROLATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 1MG/5ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for glycopyrrolate
Paragraph IV (Patent) Challenges for GLYCOPYRROLATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
CUVPOSA | SOLUTION;ORAL | glycopyrrolate | 022571 | 2012-06-20 |
ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2010-10-12 |
ROBINUL FORTE | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
ROBINUL | TABLET;ORAL | glycopyrrolate | 012827 | 2009-08-14 |
US Patents and Regulatory Information for glycopyrrolate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 086947-001 | Jun 24, 1983 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Casper Pharma Llc | ROBINUL FORTE | glycopyrrolate | TABLET;ORAL | 012827-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Watson Labs | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 086178-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Hospira | GLYCOPYRROLATE | glycopyrrolate | INJECTABLE;INJECTION | 089393-001 | Jun 15, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Aurolife Pharma Llc | GLYCOPYRROLATE | glycopyrrolate | TABLET;ORAL | 202675-001 | Apr 15, 2013 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for glycopyrrolate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | Start Trial | Start Trial |
Sunovion Resp | LONHALA MAGNAIR KIT | glycopyrrolate | SOLUTION;INHALATION | 208437-001 | Dec 5, 2017 | Start Trial | Start Trial |
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | Start Trial | Start Trial |
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for glycopyrrolate
Country | Patent Number | Estimated Expiration |
---|---|---|
Czech Republic | 20023437 | Start Trial |
United Kingdom | 0029265 | Start Trial |
Germany | 102005038619 | Start Trial |
Singapore | 146648 | Start Trial |
Mexico | PA02010212 | Start Trial |
European Patent Office | 2883564 | Start Trial |
European Patent Office | 1274406 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for glycopyrrolate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1267866 | SPC/GB13/020 | United Kingdom | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928 |
1267866 | 122013000029 | Germany | Start Trial | PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
1267866 | 132013902141564 | Italy | Start Trial | PRODUCT NAME: GLICOPIRRONIO BROMURO(SEEBRI BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/788/001-006, 20120928 |
1267866 | 300583 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
1267866 | C300583 | Netherlands | Start Trial | PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928 |
1267866 | 2014C/022 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME) |
1267866 | 493 | Finland | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |