Forteo Drug Patent Profile
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Which patents cover Forteo, and when can generic versions of Forteo launch?
Forteo is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-seven patent family members in twenty-five countries.
The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Forteo
A generic version of Forteo was approved as teriparatide by APOTEX on November 16th, 2023.
Summary for Forteo
International Patents: | 37 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 73 |
Patent Applications: | 1,432 |
Drug Prices: | Drug price information for Forteo |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Forteo |
What excipients (inactive ingredients) are in Forteo? | Forteo excipients list |
DailyMed Link: | Forteo at DailyMed |
Recent Clinical Trials for Forteo
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
RANI Therapeutics | Phase 1 |
Daniel Horwitz | Phase 4 |
Radius Health, Inc. | Phase 4 |
Pharmacology for Forteo
Drug Class | Parathyroid Hormone Analog |
Anatomical Therapeutic Chemical (ATC) Classes for Forteo
Paragraph IV (Patent) Challenges for FORTEO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FORTEO | Injection | teriparatide | 250 mcg/mL, 2.4 mL prefilled Pen | 021318 | 1 | 2015-07-27 |
US Patents and Regulatory Information for Forteo
Forteo is protected by one US patents.
Patents protecting Forteo
Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 Forteo
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for Forteo
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
STADA Arzneimittel AG | Movymia | teriparatide | EMEA/H/C/004368 Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-11 | |
Eli Lilly Nederland B.V. | Forsteo | teriparatide | EMEA/H/C/000425 Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | no | no | 2003-06-10 | |
Gedeon Richter Plc. | Terrosa | teriparatide | EMEA/H/C/003916 Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-04 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for Forteo
See the table below for patents covering Forteo around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1059933 | ⤷ Try a Trial | |
Japan | 4405666 | ⤷ Try a Trial | |
Cyprus | 1114000 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |