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Generated: December 18, 2017

DrugPatentWatch Database Preview

Leuprolide acetate; norethindrone acetate - Generic Drug Details

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What are the generic drug sources for leuprolide acetate; norethindrone acetate and what is the scope of leuprolide acetate; norethindrone acetate freedom to operate?

Leuprolide acetate; norethindrone acetate
is the generic ingredient in one branded drug marketed by Abbvie Endocrine and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate; norethindrone acetate has fifteen patent family members in eight countries.

There are twenty-one drug master file entries for leuprolide acetate; norethindrone acetate. One supplier is listed for this compound.

Summary for leuprolide acetate; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie EndocrineLUPANETA PACKleuprolide acetate; norethindrone acetateINJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-002Dec 14, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Abbvie EndocrineLUPANETA PACKleuprolide acetate; norethindrone acetateINJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-001Dec 14, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: leuprolide acetate; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie EndocrineLUPANETA PACKleuprolide acetate; norethindrone acetateINJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-001Dec 14, 2012► Subscribe► Subscribe
Abbvie EndocrineLUPANETA PACKleuprolide acetate; norethindrone acetateINJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-002Dec 14, 2012► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: leuprolide acetate; norethindrone acetate

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
5,851,451 Production of microspheres► 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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International Patent Family for Ingredient: leuprolide acetate; norethindrone acetate

Country Document Number Estimated Expiration
Japan2008291041► Subscribe
Japan2001252552► Subscribe
Denmark1142567► Subscribe
Germany69635249► Subscribe
Spain2249362► Subscribe
JapanH09221418► Subscribe
Austria219662► Subscribe
European Patent Office1142567► Subscribe
Japan4988660► Subscribe
Canada2192782► 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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Daiichi Sankyo

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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