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Generated: June 29, 2017
What are the generic sources for testosterone and what is the scope of testosterone freedom to operate?
Testosterone is the generic ingredient in eighteen branded drugs marketed by Eli Lilly And Co, Abbvie, Auxilium Pharms Inc, Watson Labs, Actavis Labs Ut Inc, Auxilium Pharms Llc, Par Pharm, Perrigo Israel, Alza, Endo Pharms, Ani Pharms Inc, Aytu Bioscience Inc, Allergan Sales Llc, Upsher-smith Labs, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Pharmacia And Upjohn, Hikma Farmaceutica, Mylan Institutional, West-ward Pharms Int, Bel Mar, Lilly, Elkins Sinn, and Endo Pharms Inc, and is included in forty-eight NDAs. There are forty-six patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 18 |
| Patents: | 46 |
| Applicants: | 26 |
| NDAs: | 48 |
| Drug Master File Entries: see list | 61 |
| Suppliers / Packagers: see list | 17 |
| Bulk Api Vendors: see list | 52 |
| Clinical Trials: see list | 728 |
| Patent Applications: see list | 9,898 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | testosterone at DailyMed |
| Ingredient-type | Androstanes |
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 30MG/1.5ML | SOLUTION;TOPICAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Perrigo Israel | TESTOSTERONE | testosterone | SOLUTION, METERED;TRANSDERMAL | 204255-001 | Feb 28, 2017 | AT | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 201720-002 | Jun 3, 2013 | AO | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Institutional | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 040647-001 | Oct 5, 2009 | AO | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Watson Labs | TESTOSTERONE ENANTHATE | testosterone enanthate | INJECTABLE;INJECTION | 083667-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hikma Farmaceutica | TESTOSTERONE CYPIONATE | testosterone cypionate | INJECTABLE;INJECTION | 091244-001 | May 1, 2012 | AO | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-002 | Oct 12, 1993 | 4,725,439 | ► Subscribe | ||||||||||||||||||||||
Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-001 | Oct 12, 1993 | 4,867,982 | ► Subscribe | ||||||||||||||||||||||
Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-002 | Oct 12, 1993 | 4,867,982 | ► Subscribe | ||||||||||||||||||||||
Alza | TESTODERM | testosterone | FILM, EXTENDED RELEASE;TRANSDERMAL | 019762-002 | Oct 12, 1993 | 4,704,282 | ► Subscribe | ||||||||||||||||||||||
Eli Lilly And Co | AXIRON | testosterone | SOLUTION, METERED;TRANSDERMAL | 022504-001 | Nov 23, 2010 | 8,071,075 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,153,845 | Bioadhesive progressive hydration tablets | ► Subscribe | |||||||||||||||||||||||||||
| 2,014,073,618 | ► Subscribe | ||||||||||||||||||||||||||||
| 7,157,097 | Penetration enhancing and irritation reducing systems | ► Subscribe | |||||||||||||||||||||||||||
| 6,916,486 | Transdermal delivery of analgesics | ► Subscribe | |||||||||||||||||||||||||||
| 7,438,203 | Dermal penetration enhancers and drug delivery systems involving same | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100861603 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 019214 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 047722 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1011632 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 8699501 | ► 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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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 00010 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 2012 00012 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 973 | Luxembourg | ► Subscribe | 91973, EXPIRES: 20220219 | ||||||||||||||||||||||||||
| 00521 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| 972 | Luxembourg | ► Subscribe | 91972, EXPIRES: 20220219 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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