FORTEO Drug Patent Profile
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When do Forteo patents expire, 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 |
Radius Health, Inc. | Phase 4 |
Daniel Horwitz | 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 | 021318-001 | Nov 26, 2002 | ⤷ 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
When does loss-of-exclusivity occur for FORTEO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05231731
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 26052
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0509269
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 57897
Estimated Expiration: ⤷ Try a Trial
China
Patent: 33864
Estimated Expiration: ⤷ Try a Trial
Patent: 0581607
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191242
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 32628
Estimated Expiration: ⤷ Try a Trial
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 9497
Estimated Expiration: ⤷ Try a Trial
Patent: 0601801
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 32628
Estimated Expiration: ⤷ Try a Trial
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 45180
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7829
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 68982
Estimated Expiration: ⤷ Try a Trial
Patent: 74233
Estimated Expiration: ⤷ Try a Trial
Patent: 07530240
Estimated Expiration: ⤷ Try a Trial
Patent: 07530241
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06011230
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 411
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9099
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 6161
Estimated Expiration: ⤷ Try a Trial
Patent: 064955
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 32628
Estimated Expiration: ⤷ Try a Trial
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 818
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 32629
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0606885
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 0763051
Estimated Expiration: ⤷ Try a Trial
Patent: 060131946
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 69671
Estimated Expiration: ⤷ Try a Trial
Patent: 28788
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering FORTEO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1308545 | ⤷ Try a Trial | |
Peru | 20001089 | METODO PARA INCREMENTAR LA DUREZA Y RESISTENCIA OSEA | ⤷ Try a Trial |
Malaysia | 129227 | METHOD FOR INCREASING BONE TOUGHNESS AND STIFFNESS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |