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Generated: July 23, 2017
What are the generic drug sources for leuprolide acetate and what is the scope of leuprolide acetate patent protection?
Leuprolide acetate is the generic ingredient in seven branded drugs marketed by Abbvie Endocrine Inc, Genzyme, Sandoz, Tolmar Therap, Teva Pharms Usa, Sun Pharma Global, Ortho Mcneil Janssen, and Abbvie Endocrine, and is included in sixteen NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 24 |
| Applicants: | 8 |
| NDAs: | 16 |
| Drug Master File Entries: see list | 21 |
| Suppliers / Packagers: see list | 6 |
| Bulk Api Vendors: see list | 38 |
| Clinical Trials: see list | 979 |
| Patent Applications: see list | 9,692 |
| Therapeutic Class: | Hormonal Agents, Suppressant (Pituitary) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | leuprolide acetate at DailyMed |
| Drug Class | Gonadotropin Releasing Hormone Receptor Agonist |
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | 6,626,870 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | RX | Yes | Yes | 9,283,282 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Sun Pharma Global | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 078885-001 | Mar 9, 2009 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-005 | Jan 21, 1994 | RX | Yes | Yes | 6,036,976 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | 8,486,455 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | 5,330,767 | ► Subscribe | ||||||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-005 | Jan 21, 1994 | 6,036,976 | ► Subscribe | ||||||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-007 | Aug 15, 2011 | 5,575,987 | ► Subscribe | ||||||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | 6,036,976 | ► Subscribe | ||||||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 5,631,020 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,246,987 | Controlled release composition and method of producing the same | ► Subscribe | |||||||||||||||||||||||||||
| 6,261,584 | Sustained delivery of an active agent using an implantable system | ► Subscribe | |||||||||||||||||||||||||||
| 5,851,451 | Production of microspheres | ► Subscribe | |||||||||||||||||||||||||||
| 7,655,257 | Sustained delivery of an active agent using an implantable system | ► Subscribe | |||||||||||||||||||||||||||
| 8,535,701 | Sustained delivery of an active agent using an implantable system | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 100388916 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2263788 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2001527035 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 200970600 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2315890 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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